Transcript
44 Adverse Events Project 44 Clinical Management Application 45 Custom Development Collection/ 46 Data Management Mining and 48 Data Visualization 48 Data Warehousing 49 Document Management Data 50 Electronic Capture (EDC) 52 Electronic Submissions 54 IT Consulting 54 Knowledge Management 55 Medical Imaging 55 Statistical Analysis 56 Training Management/ 56 Trials Administration 57 Validation 57 Web-Based Software Services 58 Wireless/Mobile Technologies 58 Other Applications
Clinical Project Management AEC Software 22611-113 Markey Ct., Sterling, VA 20166, USA, (703) 450-1980, fax (703) 450-9786, e-mail:
[email protected], www.aecsoft.com
Details 3.0 See Data Collection/Management FastTrack Schedule 7.0 FastTrack Schedule 7.0 delivers
The Applied Clinical Trials 2001 IT Solutions Directory presents information about applications used in the conduct of clinical trials. It is compiled from information provided by application developers, and Applied Clinical Trials cannot accept responsibility for the accuracy of the information they supplied.
tools to organize tasks, meet deadlines, and achieve project goals. This award-winning program creates clear, precise schedules, calendars, and resource graphs with ease. Outline activities for multiple clinical projects, establish task dependencies—even track people, equipment, and costs. FastTrack Schedule 7.0 is available for Macintosh, Windows, and Palm OS.
Araccel Corporation
Adverse Events Acumen Healthcare Solutions, LLC TracIt2k EDC System See Electronic Data Capture (EDC)
BioObjects, Inc. Web Services See Web-Based Software Services
Cardinal systems
Internet-intranet application.
PQIntelligence See Knowledge Management RegistryExpert See Data Collection/Management ReportExpert See Data Mining and Visualization TrackExpert See Data Collection/Management
OmniComm Systems, Inc.
Araccel Solutions Platform See Electronic Data Capture (EDC)
Axio Research Corporation Internet-based data management services See Data Collection/Management
Biostat, Inc. Power And Precision See Statistical Analysis
TrialMaster See Data Collection/Management
Cardiff Software, Inc.
Phase Forward Incorporated InForm See Electronic Data Capture (EDC)
LiquidOffice See Electronic Submissions TELEform See Data Collection/Management
USA, (203) 588-3000, fax (203) 356-1673, e-mail:
[email protected], www.clinarium.com
ProIRB Plus, Inc.
Cardinal systems
PRO_IRB See Trials Management/Administration
CRFSuite and DBMSuite See Electronic Data Capture
ARISg ARISg is an advanced drug safety surveillance
QED Solutions, Inc. 8300 Greensboro Dr., Ste.
system designed to meet the regulatory requirements for the global collection, assessment, reporting, and analysis of clinical and postmarketing adverse event data.
970, McLean, VA 22102, USA, (703) 821-3200, fax (703) 821-0600, e-mail:
[email protected], www.qedrx.com
Clinarium 2777 Summer St., Stamford, CT 06902,
Qscan QED Solutions specializes in lifecycle drug safety
e-TRIALS e-TRIALS is a comprehensive Web-based clini-
WebCRF See Electronic Data Capture (EDC)
management and pharmacovigilance. QED has developed a host of software platforms to support data conversion and cleanup, coding, and analysis. Qscan is an integrated offering, which includes data, tools, and a “Q” Team that acts as an extension of a biopharmaceutical research department.
cal trials management system that enables you to plan, track, and control the entire clinical trials process, from protocol design to completion of the final report, while utilizing the Internet for global trial participation and real-time information exchange.
DataLabs
ClinicalTrialsNet Inc.
StudyBuilder B.V.
ClinTriNet See Web-Based Software Services
StudyBuilder Enterprise Edition See Electronic Data
ClinPhone Group Ltd. Lady Bay House, Meadow
CRFSuite and DBMSuite See Electronic Data Capture (EDC)
Clinarium 2777 Summer St., Stamford, CT 06902,
Clinsoft Corporation Clintrial, Clintrial Connect, Clintrace See Trials Management/Administration
CompleWare Corporation
DataLabs CTMS See Clinical Project Management
DataScout Software, Inc.
Capture (EDC)
IVRQuest See Clinical Project Management
Synteract 187 Calle Magdalena, Encinitas, CA
Dendrite International, Inc. eClinical Global Deployment Facilitators See Electronic
92024, USA, (760) 634-2133, fax (760) 634-2170, e-mail:
[email protected], www.synteract.com
Data Capture (EDC)
SynCoder SynCoder is an SAS application that imple-
eResearchTechnology, Inc.
ments the MedDRA terminology, as well as COSTART and WHO-DRUG dictionaries, for coding adverse event and medication text reported during clinical trials or postmarketing. The product requires SAS v8.1 or higher, and works with SAS v6 or v8 databases.
eResearch Network and Community Technologies See Electronic Data Capture (EDC)
INC Research Clinical Drug Development Services See Data
(EDC) USA, (203) 588-3000, fax (203) 356-1673, e-mail:
[email protected], www.clinarium.com
Grove, Nottingham NG2 3HF, UK, +44 115 9557333 or (609) 620-7000 (USA), fax +44 115 9557555, e-mail:
[email protected], www.clinphone.com Providing IT solutions that accelerate the drug development process, ClinPhone applications include IVR, EDC, and ePatient Diaries. These services allow sponsors to track study progress, collect clinical subject data, manage drug supply, and screen/randomize patients. These applications are reported in real-time using a Web-based client interface. ClinPhone—making the clinical trial connection.
Collection/Management
TrialTrac, Inc.
LifeTree Technology, LLC
SiteTrac See Trials Management/Administration TrialWorks See Trials Management/Administration
Clinsoft Corporation
LifeTree ICTM See Electronic Data Capture (EDC)
MAJARO InfoSystems Inc.
Winchester Business Systems, Inc. 50
ClinAccess Casebook See Data Collection/Management ClinAccess Dictionary Coder See Data Collection/
Cross St., Winchester, MA 01890, USA, (781) 7297150, fax (781) 729-7211, e-mail:
[email protected], www.wbsnet.com
CompleWare Corporation
Management
ClinAccess PowerServer See Data Collection/
adWatch adWatch helps the clinical trial team track AEs
Management
and SAEs as well as product inquiries and complaints from around the world. Integrates seamlessly with Protocol Manager, our clinical trials management system. Automatically generates CIOMS and MEDWATCH 3500 reports for electronic submission.
MarCon Global Data Solutions, Inc.
Custom application development See Custom Application
Management
ClinAccess SureStart See Data Collection/Management ClinAccess Web Component See Data Collection/
See Clinical Project Management
Development
NetRegulus One Tower Lane, Ste. 1700, Oakbrook
Health Agency Tracking See Document Management Product Complaint Management Product Complaint
Terrace, IL 60181, USA, (888) 707-6900, fax (630) 573-6050, e-mail:
[email protected], www. netregulus.com
ActivityExpert See Electronic Data Capture (EDC) IssueExpert IssueExpert provides all the tools and capabilities necessary for collecting, documenting, tracking, trending, and reporting product quality issues including adverse events, CAPA management, audit management, complaints, nonconformities, vigilance reporting, product tracking, and more. This 21 CFR 11–compliant module is available as a client-server or
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Management System documents the product inquiry and complaint lifecycle for medical devices. System manages product registration, inquiries, complaints, investigations, return material authorizations, repairs, adverse events, medical device reports, CIOMS, MEDWATCH 3500, and customer notifications. Meets 21 CFR 11 requirements for electronic submission.
Protocol Manager See Clinical Project Management
Clintrial, Clintrial Connect, Clintrace See Trials Management/Administration
WebCRF See Electronic Data Capture (EDC)
CRF Box Ltd. CRF Box Wireless See Electronic Data Capture (EDC)
DataLabs 17310 Redhill Ave., Ste. 200, Irvine, CA 92614, USA, (949) 851-2030, fax (949) 851-2043, e-mail:
[email protected], www.datalabsinc.com
DataLabs CTMS DataLabs CTMS is the first Internetbased product that integrates the elements of project, data, and document management into a single application. Based in Microsoft’s NET framework and servers, this integrated approach provides significant benefits, including an accelerated time to market, lower development costs, and improved research quality.
Datapharm Australia Pty. Ltd. 56-56A Thompson St., Drummoyne, NSW 2047, Australia, +61 2 9719 2800, fax +61 2 9719 2811, e-mail:
[email protected], www.datapharm.com.au
SMART SMART (Smooth Monitoring A Resource Tool) was developed by Datapharm to assist project managers of clinical trials to assess and track monitoring requirements over several projects and to adjust estimates based on actuals iteratively. It is quick to use and allows monitoring of actuals vs. estimated progress APPLIED CLINICAL TRIALS
August 2001
milestones.
DataScout Software, Inc. 6817 Falls of the Neuse Rd., Ste. 106, Raleigh, NC 27615, USA, (919) 866-1712 ext. 13, or (919) 866-1712 ext. 14, fax (919) 866-1727, e-mail:
[email protected], www.datascoutsoftware.com
IVRQuest IVRQuest is innovative interactive voice (IVR) and Web response software for clinical research. IVRQuest accelerates study initiation while ensuring compliance with 21 CFR 11 for electronic records. IVRQuest is configurable for management of multiple multilingual IVR processes for randomization, enrollment, subject diaries, EDC, site activation, and clinical supply requests.
DATATRAK
ClinAccess SureStart See Data Collection/Management ClinAccess Web Component See Data Collection/
CompleWare Corporation
Management
DataLabs
MarCon Global Data Solutions, Inc. 2736
DataLabs CTMS See Clinical Project Management
NW 22nd Terrace, Gainesville, FL 32605, USA, (352) 870-9843, fax (352) 378-5526, e-mail: ronmarks@ marconglobal.com, www.marconglobal.com
Datapharm Australia Pty. Ltd.
MarCon’s Web-based clinical research management system centralizes and coordinates clinical trials processes, including EDC, IRB, randomization, medication distribution, compensation, AE reporting, and provides comprehensive reports for sponsors, sites, and monitors to maximize trial efficiency and accuracy. The MarCon system enhances subject safety through coordination of trial safety processes.
TrialOne Services See Electronic Data Capture (EDC)
WebCRF See Electronic Data Capture (EDC)
SMART See Clinical Project Management
Datasential LLC First Consulting Group FirstDocs for CRFs See Document Management
Health Care Online, Inc. HCOL Clinical Study Enterprise Edition See Electronic Data Capture (EDC)
Intrasphere Technologies, Inc.
DATATRAK EDC See Electronic Data Capture (EDC)
NetRegulus
Systems Integration See IT Consulting
Dendrite International, Inc.
ActivityExpert See Electronic Data Capture (EDC) PQIntelligence See Knowledge Management RegistryExpert See Data Collection/Management ReportExpert See Data Mining and Visualization StudyExpert See Trials Management/Administration TrackExpert See Data Collection/Management
Kronos Communicated Data, Inc. 860
eClinical Global Deployment Facilitators See Electronic Data Capture (EDC)
ETRAC Solutions, Inc. One Martin Ave., Cherry Hill, NJ 08002, USA, (856) 662-1290, fax (856) 6628540, e-mail:
[email protected], www. etracsolutions.com
Project Management Solutions ETRAC Solutions, Inc. is an international consulting and software sales organization specializing in the implementation of project management solutions and enterprise resource planning. We offer an extensive curriculum of programs covering project management concepts and methodology, expert process consulting, Primavera certified training, and sales of project management software.
First Consulting Group FirstDocs for CRFs See Document Management
Fortress Medical Systems, Inc. Clindex 2.0 See Data Collection/Management
FW Pharma Systems IMPACT See Trials Management/Administration INITIATOR See Trials Management/Administration
Health Care Online, Inc. HCOL Clinical Study Enterprise Edition See Electronic Data Capture (EDC)
Lower Ferry Rd., Trenton, NJ 08628, USA, (888) 5381690 or (609) 538-9205, fax (609) 538-9208, e-mail:
[email protected], www.kronosdata.com
Numoda mTrial See Wireless/Mobile Technologies
APERS Reduce time to locked database with IVR and Web-based platforms for real-time enrollment, randomization, study drug management, and subject diaries. Specializing in systems tailored to maximize study team effectiveness, these fully supported systems are delivered in three to six weeks.
Phase Forward Incorporated
OutcomesCall Reduce time to locked database with IVR
Numoda Corporation
InForm See Electronic Data Capture (EDC)
ProIRB Plus, Inc. PRO_IRB See Trials Management/Administration
Propack Data Corp. PMX CTM Solution See Trials Management/
and Web-based platforms for real-time enrollment, randomization, study drug management, and subject diaries. Specializing in systems tailored to maximize study team effectiveness, these fully supported systems are delivered in three to six weeks.
Administration
MAJARO InfoSystems Inc.
StudyBuilder B.V.
ClinAccess Casebook See Data Collection/Management ClinAccess Dictionary Coder See Data Collection/
StudyBuilder Enterprise Edition See Electronic Data Capture (EDC)
Management
TrialTrac, Inc.
ClinAccess PowerServer See Data Collection/
SiteTrac See Trials Management/Administration TrialWorks See Trials Management/Administration
Management
Valid Systems Incorporated
ClinAccess SureStart See Data Collection/Management ClinAccess Web Component See Data Collection/
Records Manager for Lotus Notes Mail See Knowledge
Management
iBiomatics
Management
P21 Biomedical Knowledge Platform See Data Ware-
NetRegulus
Winchester Business Systems, Inc. 50 Cross St., Winchester, MA 01890, USA, (781) 7297150, fax (781) 729-7211, e-mail: sales@ WBSNET.com, www.wbsnet.com
ActivityExpert See Electronic Data Capture (EDC) IssueExpert See Adverse Events PQIntelligence See Knowledge Management RegistryExpert See Data Collection/Management ReportExpert See Data Mining and Visualization StudyExpert See Trials Management/Administration TrackExpert See Data Collection/Management
housing
idv Data Analysis & Study Planning Wessobrunner Str. 6, 82131 Gauting/Munich, Germany, +49 89 8508001, fax +49 89 8503666, e-mail:
[email protected]
ICH-Study-Report-Manager Systems supported: Windows 95/98/2000/NT/ME. This program dramatically speeds the creation of a clinical research report conforming to ICH guidelines. It is directly implemented into Word and offers: default phrases, hundreds of predefined tables for depicting results, easy inclusion of figures and text files.
N See Statistical Analysis Nnpar 1.0 See Statistical Analysis Nsurv See Statistical Analysis Rancode Prof. See Statistical Analysis
adWatch See Adverse Events Custom application development See Custom Application Development
Health Agency Tracking See Document Management Protocol Manager Protocol Manager is a fully functional Web-enabled software suite that helps an entire trial team (sponsor, CRO, SMO, site, investigator, and CRA) manage all documents associated with clinical trials— all investigator documents, protocol documents, inventory, SOPs, subject recruiting, SAEs, and financials. Validation software is included.
Custom Application Development
Study Assistant See Data Collection/Management Clinical Drug Development Services See Data Collection/Management
Insightful Corporation S-PLUS and SeqTrial, Server Products See Statistical Analysis
Invantage, Inc. Investigator DataWeb System See Trials Management/ Administration
LifeTree Technology, LLC LifeTree ICTM See Electronic Data Capture (EDC)
MAJARO InfoSystems Inc. ClinAccess Casebook See Data Collection/Management ClinAccess Dictionary Coder See Data Collection/ Management
ClinAccess PowerServer See Data Collection/ Management
August 2001
APPLIED CLINICAL TRIALS
Numoda mTrial See Wireless/Mobile Technologies
OmniComm Systems, Inc. TrialMaster See Data Collection/Management
Propack Data Corp. PMX CTM Solution See Trials Management/ Administration
iMedRIS Data Corp. INC Research
Numoda Corporation
Araccel Corporation Araccel Solutions Platform See Electronic Data Capture (EDC)
BBK Healthcare, Inc. TrialCentral.net See Knowledge Management
Cardinal systems CRFSuite and DBMSuite See Electronic Data Capture (EDC)
CB Technologies, Inc. MetaTrial See Electronic Data Capture (EDC)
ClickFind MED ClickTrials See Web-Based Software Services
ClinicalTrialsNet Inc. ClinTriNet See Web-Based Software Services
ClinPhone Group Ltd.
Check Your Information If you submitted information for the 2001 IT Solutions directory, please carefully examine your listings, and contact us about any problems. If necessary, we will publish an addendum with corrected information in a subsequent ACT issue. Send corrections to IT Solutions Editor Applied Clinical Trials 859 Willamette Street Eugene, OR 97401-6806 fax: (541) 984-5250 e-mail:
[email protected]
See Clinical Project Management
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QED Solutions, Inc. Qscan See Adverse Events
StudyBuilder B.V. StudyBuilder Enterprise Edition See Electronic Data Capture (EDC)
TrialTrac, Inc. SiteTrac See Trials Management/Administration TrialWorks See Trials Management/Administration
Internet can provide speed, quality, and cost savings for your next trial.
Cardiff Software, Inc. 3220 Executive Ridge Dr., Vista, CA 92083, USA, (760) 936-4500, fax (760) 936-4800, e-mail:
[email protected], www.cardiff.com LiquidOffice See Electronic Submissions TELEform TELEform streamlines collection of data from
Spirotrac Centralized Spirometry System See Electronic
paper and online forms. Built-in business rules and intuitive validation processes help you quickly capture accurate information. Operators spend seconds verifying data rather than minutes manually keying entire forms. Connects to leading clinical database applications, including SAS, SPSS, Oracle Clinical, and Clintrial.
Data Capture (EDC)
Cardinal systems
Winchester Business Systems, Inc. 50
CRFSuite and DBMSuite See Electronic Data Capture
Cross St., Winchester, MA 01890, USA, (781) 7297150, fax (781) 729-7211, e-mail:
[email protected], www.wbsnet.com
CB Technologies, Inc.
adWatch See Adverse Events Custom application development Winchester Business
ClickFind MED
Systems develops software applications for pharmaceutical, biotechnology, and medical device companies that are designed to improve drug and product development processes. Winchester employs Lotus Notes/Domino technology for multisite/multivendor clinical trials projects, electronic data collection, workflow management and project management systems, information management, and exception reporting for decision support.
Clinical DataFax Systems Inc. 21 King St.
Vitalograph Ltd. Electronic PEF/FEV1 Diary See Electronic Data Capture (EDC)
Health Agency Tracking See Document Management paraFILE See Document Management Product Complaint Management See Adverse Events Protocol Manager See Clinical Project Management
Zurich Biostatistics, Inc.
(EDC)
MetaTrial See Electronic Data Capture (EDC) ClickTrials See Web-Based Software Services West, Ste. 305, Hamilton, ON L8P 4W7, Canada, (905) 522-3282, fax (905) 522-7284, email: info@datafax. com, www.datafax.com
their own studies and data entry systems, collect and monitor data, manage and compensate physicians, report on data, and interface to statistical packages. Clindex is the clinical trial in a box solution!
Health Care Online, Inc. HCOL Clinical Study Enterprise Edition See Electronic Data Capture (EDC)
iBiomatics PH.Dataware See Data Warehousing
iMedRIS Data Corp. 36213 Highland Ave., Yucaipa, CA 92399, USA, (909) 520-9164, fax (909) 797-3100, e-mail:
[email protected], www.imedris. com
Study Assistant iMedRis has designed an application that integrates clinical study management and data capture. Sites now have the ability to manage all aspects of clinical studies including subject data, study information, visit tracking, screening, reporting, and budget/financial information while having the ability to design, capture, and export data into other applications.
INC Research 6131 Falls of the Neuse Rd., Ste. 200, Raleigh, NC 27609, USA, (919) 876-9300, fax (919) 876-9360, e-mail:
[email protected], www.incresearch.com
DataFax A complete clinical trials management solution using CRFs and simple fax technology at the clinical sites and powerful software at the coordinating center including: intelligent character recognition from faxed CRFs, query tracking, standard reports, audit trails, study setup tool, bookmarked PDFs of patient CRFs, acceptance test kit, and much more.
Clinical Drug Development Services INC Research, a fullservice contract research organization, manages all aspects of clinical drug development programs for pharmaceutical and biotechnology companies developing drugs and devices used for disorders of the central nervous system. In addition, we have specialized experience in providing clinical data services across all therapeutic areas.
ClinicalTrialsNet Inc.
InferMed Limited
ClinTriNet See Web-Based Software Services
MACRO See Electronic Data Capture (EDC)
ClinPhone Group Ltd.
Insightful Corporation
Tekoa XML Automation Technology See Statistical
See Clinical Project Management
S-PLUS and SeqTrial, Server Products See Statistical
Analysis
Clinsoft Corporation
Analysis
Clintrial, Clintrial Connect, Clintrace See Trials
invivodata, inc. 5615 Scotts Valley Dr., Ste. 150,
Management/Administration
WebCRF See Electronic Data Capture (EDC)
Scotts Valley, CA 95066, USA, (831) 438-9550, fax (831) 440-1770, e-mail:
[email protected], www.invivodata.com
CRF Box
invivosystem The invivosystem is a subject-focused
CRF Box Wireless See Electronic Data Capture (EDC)
DataLabs CTMS See Clinical Project Management
solution for collecting real-time, real-world subject experience data for clinical research that is valid, reliable, and timely. Using hand-held technology, invivosystem supports all study phases by applying human factors and concepts from clinical psychology to facilitate subject compliance and collection of valid data.
Tekoa XML Technology See Data Collection/Management
Data Collection/ Management Acumen Healthcare Solutions, LLC TracIt2k EDC System See Electronic Data Capture (EDC)
CompleWare Corporation
DataCeutics, Inc. Clinical Information Technology Consulting See IT
Adapt~EDC, LLC 5872 York Rd., PO Box 663,
Consulting
Lahaska, PA 18931, USA, (215) 794-8028, fax (215) 794-8028, e-mail:
[email protected], www. adaptedc.com
DataLabs
Adapt~EDC Clinical Trials Suite Adapt~EDC serves the pharmaceutical and biotechnology industries by developing and supporting advanced software applications and outsourcing services designed to dramatically reduce the costs and time associated with the collection, distribution, and analysis of clinical trial data. Adapt~EDC enables companies to make go, no-go decisions much earlier than ever before possible.
Datapharm Australia Pty. Ltd.
Kronos Communicated Data, Inc.
eCRF See Electronic Data Capture (EDC)
Datasential LLC
APERS See Custom Application Development OutcomesCall See Custom Application Development
TrialOne Services See Electronic Data Capture (EDC)
LifeTree Technology, LLC
DATATRAK
LifeTree ICTM See Electronic Data Capture (EDC)
DATATRAK EDC See Electronic Data Capture (EDC)
Logos Technologies Ltd.
Dendrite International, Inc.
ALPHADAS See Electronic Data Capture (EDC) SMART Patient Diary Card See Electronic Data Capture
AEC Software 22611-113 Markey Ct., Sterling, VA 20166, USA, (703) 450-1980, fax (703) 450-9786, e-mail:
[email protected], www.aecsoft.com Details 3.0 Make your project information work for you! With Details, your clinical project information is centralized, organized, and always up-to-date. Instantly communicate project statuses to colleagues and clients with presentation-quality reports and colorful, custom forms. You’ll be amazed at how quickly and easily you can capture, track, and route project details.
Analyse-it Software, Ltd. Analyse-it Clinical Laboratory See Statistical Analysis
eClinical Global Deployment Facilitators See Electronic Data Capture (EDC)
(EDC)
DZS Software Solutions, Inc. 1661 Route 22
MAJARO InfoSystems Inc. 1731 Technology
West, Bound Brook, NJ 08805, USA, (732) 764-6969, fax (732) 764-6755, e-mail:
[email protected], www.clinplus.com
ClinPlus Data Management DZS Software Solutions is the leader in SAS-based software solutions for clinical data management and reporting. The ClinPlus family of products enables your company to meet its goals in a timely and cost-effective manner.
eResearchTechnology, Inc. eResearch Network and Community Technologies See
Araccel Corporation
Electronic Data Capture (EDC)
Araccel Solutions Platform See Electronic Data Capture
ETRAC Solutions, Inc.
(EDC)
Axio Research Corporation 2601 Fourth Ave., Ste. 200, Seattle, WA 98121, USA, (206) 547-2829, fax (206) 547-4671, e-mail:
[email protected], www.axioresearch.com Internet-based data management services Axio Research provides expert data management and statistical services for Internet-based clinical trials using our proprietary trial management system. Contact us to learn if our expertise coupled with the power of the
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Project Management Solutions See Clinical Project Management
First Consulting Group FirstDocs for CRFs See Document Management
Fortress Medical Systems, Inc 310 7th Ave., North Hopkins, MN 55343, USA, (952) 988-9123, e-mail:
[email protected], www.fortressmedical.com
Clindex 2.0 Clindex is in an easy-to-use Windows-based package allowing clinical trials staff to plan and create
Dr., Ste. 560, San Jose, CA 95110, USA, (408) 5621890 or (714) 985-9661, fax (408) 562-1899, e-mail:
[email protected], www.majaro.com
ClinAccess Casebook Imaging system written specifically for clinical data management. Integrates with ClinAccess PowerServer or as stand alone. Images received via fax, scan, or from file. Images tie directly to data; CRF dynamically appears throughout. Integrates with standard e-mail systems, fax servers, and Web. Tracks correspondence and other files (i.e., scans, video images). ClinAccess Dictionary Coder SAS-powered. Integrates with ClinAccess or as standalone. Works with any dictionary, including MedDRA, COSTART, WHO, or custombuilt. Autoencodes exact matches. Flexible term search, learning capabilities, entered word as replacement, etc., to assist with uncoded terms. Variety of reports. Used with entire system, images dynamically appear for easy coding. ClinAccess PowerServer Validated SAS-powered clinical data management software with integrated dictionary autoencoder, data clarification system, workflow, APPLIED CLINICAL TRIALS
August 2001
imaging, and Web components. Study setup wizards, automated forms tracking, CRF images received from scan, fax, or file links directly to data for view throughout system. Completely operational within 30 days. Easily customizable by client.
TrackExpert TrackExpert offers a centralized, easy-to-use
Propack Data Corp.
method for tracking your inventory from the factory to delivery to the patient. The software is designed to meet the regulations for implantable devices as specified by 21 CFR 821.
Administration
ClinAccess SureStart Validated SAS-powered clinical data management software with study set-up wizards, double key entry, validation, audit trails, point-and-click statistical tools, option for dictionary autoencoder (for adverse events, etc.). Designed as entry-level clinical data management system, completely upgradeable to PowerServer. Operational within 30 days. Easily customizable by client.
Numoda Corporation
ClinAccess Web Component Enter data and resolve queries using the Internet. When combined with other ClinAccess modules, supports studies in which each investigator can choose between paper CRFs, fax, or Web CRFs, while entering all data into a single SAS database. Call for availability.
MarCon Global Data Solutions, Inc. See Clinical Project Management
NetRegulus One Tower Lane, Ste. 1700, Oakbrook Terrace, IL 60181, USA, (888) 707-6900, fax (630) 573-6050, e-mail:
[email protected], www. netregulus.com
ActivityExpert See Electronic Data Capture (EDC) IssueExpert See Adverse Events PQIntelligence See Knowledge Management RegistryExpert RegistryExpert allows users to link and track products, patients, care facilities, capital equipment, medical professionals, and more. Register and track capital equipment and products by product number, serial/lot number, date, or your own system. Features multiple address capability to quickly locate patients with products in critical situations.
ReportExpert See Data Mining and Visualization StudyExpert See Trials Management/Administration
August 2001
APPLIED CLINICAL TRIALS
Numoda mTrial See Wireless/Mobile Technologies
OmniComm Systems, Inc. 3250 Mary St., Ste. 402, Coconut Grove, FL 33133, USA, (305) 4484700, fax (305) 448-4757, e-mail: info@omnicomm. com, www.omnicomm.com
TrialMaster OmniComm Systems provides Web-based data capture applications for the clinical trial industry. Our applications include electronic CRFs, subject enrollment tracking, randomization, e-mail communication, and a robust enterprise manager designed for trial budget, payment information, site(s) overview, and more.
PMX CTM Solution See Trials Management/
QED Solutions, Inc. Qscan See Adverse Events
SAM GmbH ars RDE system See Electronic Data Capture (EDC)
Skila, Inc. iKnow—New Product Launch See Knowledge Management
iWorksite See Knowledge Management
StudyBuilder B.V. StudyBuilder Enterprise Edition See Electronic Data Capture (EDC)
SyMetric Sciences, Inc. 1-2082 Sherbrooke
PerMedics, Inc.
West, Montreal, QC H3H 1G5, Canada, (514) 9354562, fax (514) 935-9911, e-mail:
[email protected], www.symetric.ca
Surveyor See Trials Management/Administration
SyMetric Clinical Data Management system Comprehen-
Phase Forward Incorporated
sive data management system for clinical trials including full support for double data entry, multivariate data validation, data dictionary, autoencoders for all standard dictionaries (ICD9, MedDRA, WHO, etc.), query management, flexible export to ASCII, HTML, and SAS, etc. Complies with all regulatory requirements. For more information, please visit our Web site.
InForm See Electronic Data Capture (EDC)
PHT Corporation Esendant Clinical Network See Electronic Data Capture (EDC)
PPD Informatics 84 Sherman St., Cambridge, MA 02140, USA, (617) 868-6878, fax (617) 868-2654, e-mail:
[email protected], www.ppdinformatics. com TableTrans TableTrans helps specify complex data transformations by using Oracle as a powerful data transformation engine. You can execute transformations interactively or generate SQL scripts for batch execution. Applications of TableTrans include migrating legacy databases, validating/cleaning data, creating analysis views of a database, extracting data for analysis.
Synteract SynCoder See Adverse Events
TEAMworks Clinical Services TRIALink EDC Systems See Electronic Data Capture (EDC)
Valid Systems Incorporated Records Manager for Lotus Notes Mail See Knowledge Management
Vitalograph Ltd.
ProIRB Plus, Inc.
Electronic PEF/FEV1 Diary See Electronic Data Capture
PRO_IRB See Trials Management/Administration
(EDC)
47
Spirotrac Centralized Spirometry System See Electronic
Management
CB Technologies, Inc.
Data Capture (EDC)
ClinAccess PowerServer See Data Collection/
MetaTrial See Electronic Data Capture (EDC)
Winchester Business Systems, Inc.
Management
ClickFind MED
paraFILE See Document Management
ClinAccess SureStart See Data Collection/Management ClinAccess Web Component See Data Collection/
ClickTrials See Web-Based Software Services
Zurich Biostatistics, Inc. 45 Park Place South, PMB 178, Morristown, NJ 07960, USA, (973) 727-0025 or (973) 727-0024, e-mail:
[email protected], www.zbi.net
Tekoa XML Technology Tekoa XML Technology brings XML into the SAS world. Import, process, and export XML using 100% nonexperimental base SAS tools in a way that feels natural to SAS users unfamiliar with XML. The CDISC XML ODM clinical data model is fully supported.
Data Mining and Visualization Analyse-it Software, Ltd. Analyse-it Clinical Laboratory See Statistical Analysis
Araccel Corporation Araccel Solutions Platform See Electronic Data Capture (EDC)
Cardiff Software, Inc. LiquidOffice See Electronic Submissions
ClinicalTrialsNet Inc.
Management
ClinTriNet See Web-Based Software Services
MarCon Global Data Solutions, Inc.
ClinPhone Group Ltd.
See Clinical Project Management
See Clinical Project Management
NetRegulus One Tower Lane, Ste. 1700, Oakbrook Terrace, IL 60181, USA, (888) 707-6900, fax (630) 573-6050, e-mail:
[email protected], www. netregulus.com
CompleWare Corporation
ActivityExpert See Electronic Data Capture (EDC) IssueExpert See Adverse Events PQIntelligence See Knowledge Management RegistryExpert See Data Collection/Management ReportExpert Deliver sophisticated analytical reports
DataCeutics, Inc.
from one or many databases using ReportExpert’s intuitive Web-based interface. Allows you to create unlimited ad hoc reports or drill down into important data using a library of predefined reports. Features automated reporting and e-mail generation as well as the ability to export data to popular applications.
eCRF See Electronic Data Capture (EDC)
WebCRF See Electronic Data Capture (EDC)
CRF Box CRF Box Wireless See Electronic Data Capture (EDC) Clinical Information Technology Consulting See IT Consulting
DataLabs DataLabs CTMS See Clinical Project Management
Datapharm Australia Pty. Ltd. DATATRAK DATATRAK EDC See Electronic Data Capture (EDC)
Dendrite International, Inc. eClinical Global Deployment Facilitators See Electronic Data Capture (EDC)
CRFSuite and DBMSuite See Electronic Data Capture
StudyExpert See Trials Management/Administration TrackExpert See Data Collection/Management
(EDC)
Numoda Corporation
CB Technologies, Inc.
Numoda mTrial See Wireless/Mobile Technologies
MetaTrial See Electronic Data Capture (EDC)
OmniComm Systems, Inc.
ClinicalTrialsNet Inc.
TrialMaster See Data Collection/Management
ClinTriNet See Web-Based Software Services
Management
PHT Corporation
First Consulting Group
Cardinal systems
ClinPhone Group Ltd.
Esendant Clinical Network See Electronic Data Capture
See Clinical Project Management
(EDC)
CompleWare Corporation
ProIRB Plus, Inc.
WebCRF See Electronic Data Capture (EDC)
PRO_IRB See Trials Management/Administration
CRF Box
Propack Data Corp.
CRF Box Wireless See Electronic Data Capture (EDC)
PMX CTM Solution See Trials Management/
DataCeutics, Inc.
Administration
Clinical Information Technology Consulting See IT
QED Solutions, Inc.
Consulting
Qscan See Adverse Events
DataLabs
Skila, Inc.
DataLabs CTMS See Clinical Project Management
iKnow—New Product Launch See Knowledge
Datapharm Australia Pty. Ltd.
Management
eCRF See Electronic Data Capture (EDC)
iWorksite See Knowledge Management
DATATRAK
StudyBuilder B.V.
DATATRAK EDC See Electronic Data Capture (EDC)
StudyBuilder Enterprise Edition See Electronic Data
Dendrite International, Inc.
Capture (EDC)
eClinical Global Deployment Facilitators See Electronic
Synergy Software 2457 Perkiomen Ave.,
Data Capture (EDC)
Reading, PA 19606, USA, (610) 779-0522 or (800) 876-8376, fax (610) 370-0548, e-mail: info@synergy. com, www.synergy.com
eResearchTechnology, Inc. eResearch Network and Community Technologies See Electronic Data Capture (EDC)
KaleidaGraph KaleidaGraph transforms your complex
ETRAC Solutions, Inc.
data into meaningful 2D graphs! Data can be entered or imported from an Excel or text file with a flexible import facility. Use algebraic and statistical functions to manipulate billions of data points. Graph 20 variables with precise control of plot elements. Powerful curve-fitting.
Project Management Solutions See Clinical Project Management
First Consulting Group FirstDocs for CRFs See Document Management
Health Care Online, Inc.
Valid Systems Incorporated Records Manager for Lotus Notes Mail See Knowledge
eResearchTechnology, Inc. eResearch Network and Community Technologies See Electronic Data Capture (EDC)
ETRAC Solutions, Inc. Project Management Solutions See Clinical Project
FirstDocs for CRFs See Document Management
Health Care Online, Inc. HCOL Clinical Study Enterprise Edition See Electronic Data Capture (EDC)
iBiomatics 11000 Weston Parkway, Ste. 110, Cary, NC 27513, USA, (919) 653-2700, fax (919) 653-2701, e-mail:
[email protected], www.ibiomatics.com G23 Genomics Knowledge Platform The G23 Genomics Knowledge Platform integrates data from genomic instrumentation systems and other sources, and then delivers standardized data via the Internet to researchers’ desktops. Instead of spending their time restructuring data, scientists can begin their analyses immediately, enabling them to find potential targets faster. P21 Biomedical Knowledge Platform P21 consolidates disparate data and documents into a validated, Webbased collaborative environment. Professionals in R&D, biometrics, regulatory affairs, and QA can explore biomedical data when they want to, how they want to. Because of its open architecture, you can use existing analysis tools and applications within the platform. PH.Clinical PH.Clinical provides researchers with a clinical data exploration and reporting system for generating standard or ad hoc tables, listings, and analysis output.
PH.Dataware PH.DataWare allows researchers to manage clinical trials data from a variety of sources in a clinical data warehouse.
INC Research
HCOL Clinical Study Enterprise Edition See Electronic
Management
Data Capture (EDC)
Winchester Business Systems, Inc.
Collection/Management
paraFILE See Document Management
Insightful Corporation
iBiomatics PH.Dataware See Data Warehousing
S-PLUS and SeqTrial, Server Products See Statistical
Insightful Corporation
Data Warehousing
S-PLUS and SeqTrial, Server Products See Statistical Analysis
invivodata, inc. invivosystem See Data Collection/Management
Kronos Communicated Data, Inc.
Acumen Healthcare Solutions, LLC TracIt2k EDC System See Electronic Data Capture (EDC)
Analyse-it Software, Ltd. Analyse-it Clinical Laboratory See Statistical Analysis
APERS See Custom Application Development OutcomesCall See Custom Application Development
Araccel Corporation
LifeTree Technology, LLC
(EDC)
LifeTree ICTM See Electronic Data Capture (EDC)
Cardiff Software, Inc.
MAJARO InfoSystems Inc.
LiquidOffice See Electronic Submissions
ClinAccess Casebook See Data Collection/Management ClinAccess Dictionary Coder See Data Collection/
Cardinal systems
48
Clinical Drug Development Services See Data
Araccel Solutions Platform See Electronic Data Capture
CRFSuite and DBMSuite See Electronic Data Capture (EDC)
Analysis
Kronos Communicated Data, Inc. APERS See Custom Application Development OutcomesCall See Custom Application Development
LifeTree Technology, LLC LifeTree ICTM See Electronic Data Capture (EDC)
MAJARO InfoSystems Inc. ClinAccess Casebook See Data Collection/Management ClinAccess Dictionary Coder See Data Collection/ Management
ClinAccess PowerServer See Data Collection/ Management
ClinAccess SureStart See Data Collection/Management APPLIED CLINICAL TRIALS
August 2001
ClinAccess Web Component See Data Collection/
http://lifesciences.fcg.com
P21 Biomedical Knowledge Platform See Data Ware-
Management
FirstDocs for CRFs FCG has combined the industry’s
housing
MarCon Global Data Solutions, Inc.
best practices, state-of-the-art technology, and consulting services to produce FirstDocs for CRFs, the industry’s only Documentum-based, prepackaged electronic document management solution for case report forms (CRFs). Our solution addresses highly complex document management requirements associated with CRFs.
idv Data Analysis & Study Planning
See Clinical Project Management
NetRegulus ActivityExpert See Electronic Data Capture (EDC) IssueExpert See Adverse Events PQIntelligence See Knowledge Management RegistryExpert See Data Collection/Management ReportExpert See Data Mining and Visualization StudyExpert See Trials Management/Administration TrackExpert See Data Collection/Management
Data Capture (EDC)
Numoda Corporation
iBiomatics
Fortress Medical Systems, Inc. Clindex 2.0 See Data Collection/Management
Health Care Online, Inc. HCOL Clinical Study Enterprise Edition See Electronic
Numoda mTrial See Wireless/Mobile Technologies
G23 Genomics Knowledge Platform See Data Ware-
OmniComm Systems, Inc.
housing
ICH-Study-Report-Manager See Clinical Project Management
INC Research Clinical Drug Development Services See Data Collection/Management
IntraLinks, Inc. IntraLinks digital workspaces See Web-Based Software Services
Invantage, Inc. Investigator DataWeb System See Trials Management/ Administration
LifeTree Technology, LLC LifeTree ICTM See Electronic Data Capture (EDC)
TrialMaster See Data Collection/Management
PHT Corporation Esendant Clinical Network See Electronic Data Capture (EDC)
ProIRB Plus, Inc. PRO_IRB See Trials Management/Administration
Propack Data Corp. PMX CTM Solution See Trials Management/ Administration
QED Solutions, Inc. Qscan See Adverse Events
Skila, Inc. iKnow—New Product Launch See Knowledge Management
iWorksite See Knowledge Management
StudyBuilder B.V. StudyBuilder Enterprise Edition See Electronic Data Capture (EDC)
Valid Systems Incorporated Records Manager for Lotus Notes Mail See Knowledge Management
Winchester Business Systems, Inc. paraFILE See Document Management
Document Management Adapt~EDC, LLC Adapt~EDC Clinical Trials Suite See Data Collection/ Management
Araccel Corporation Araccel Solutions Platform See Electronic Data Capture (EDC)
Cardiff Software, Inc. LiquidOffice See Electronic Submissions TELEform See Data Collection/Management
CDC Solutions Inc. EZsubs See Electronic Submissions
CompleWare Corporation WebCRF See Electronic Data Capture (EDC)
DataLabs DataLabs CTMS See Clinical Project Management
Document Control Systems, Inc. 6322 South 3000 East, Ste. 300, Salt Lake City, UT 84121, USA, (800) 825-9117, fax (801) 942-7088, e-mail:
[email protected], www.mastercontrol.com MASTERControl FDA Edition Validation-ready document control software that addresses electronic signatures/ electronic record management and document security requirements of 21 CFR 11 and FDA CGMP. This includes both the enhanced features needed to comply with those standards and assistance with validation. Software has been used by FDA companies since early 1998.
eResearchTechnology, Inc. eResearch Network and Community Technologies See Electronic Data Capture (EDC)
First Consulting Group 575 E. Swedesford Rd., Ste. 200, Wayne, PA 19087, USA, (610) 989-7000, fax (610) 989-7100, e-mail:
[email protected], August 2001
APPLIED CLINICAL TRIALS
49
ClinPhone Group Ltd.
Management
review, approve, distribute, retrieve, and manage electronic documents globally—documents from any computer source or application. Document creation, review, and approval is done collaboratively. Manage NDAs, submissions, SOPs, protocols, etc. Exceeds requirements for electronic signatures and records as required by 21 CFR 11 regulation.
ClinAccess SureStart See Data Collection/Management ClinAccess Web Component See Data Collection/
Product Complaint Management See Adverse Events Protocol Manager See Clinical Project Management
City, IA 52244, USA, (319) 338-8888 or (800) 3698888, fax (319) 338-1604, e-mail: info@compleware. com, www.compleware.com
MAJARO InfoSystems Inc. ClinAccess Casebook See Data Collection/Management ClinAccess Dictionary Coder See Data Collection/ Management
ClinAccess PowerServer See Data Collection/
See Clinical Project Management
Clinsoft Corporation Clintrial, Clintrial Connect, Clintrace See Trials Management/Administration
CompleWare Corporation PO Box 3090, Iowa
Management
Zurich Biostatistics, Inc.
NetRegulus
WebCRF WebCRF allows for the complete integration of
Tekoa XML Automation Technology See Statistical
ActivityExpert See Electronic Data Capture (EDC) IssueExpert See Adverse Events PQIntelligence See Knowledge Management RegistryExpert See Data Collection/Management ReportExpert See Data Mining and Visualization StudyExpert See Trials Management/Administration TrackExpert See Data Collection/Management
Analysis
case report form (CRF), diary, laboratory, ECG, and spirometry data. Data is available online, 24 hours a day, 7 days a week, increasing monitoring capabilities and allowing clinical trials to be completed much more rapidly than with other data collection methods.
Electronic Data Capture (EDC) Acumen Healthcare Solutions, LLC 14252
Numoda Corporation
23rd Ave. North, Plymouth, MN 55447, USA, (763) 5598232 ext. 24, fax (765) 559-2821, e-mail: wgk@ winternet.com, www.acumenhealthcare.com
Numoda mTrial See Wireless/Mobile Technologies
TracIt2k EDC System TracIt2k is a fully automated, off-
OmniComm Systems, Inc.
Administration
line EDC system that cleanses and validates all data prior to transmission to a sponsor. The system also automatically maps and uploads to any ODBC database. Acumen also provides Web-based EDC and wireless technology. To speed up and reduce the cost of trials, use TracIt2k.
QUMAS Inc. 325 Columbia Turnpike, Florham
Adapt~EDC, LLC
Park, NJ 07932, USA, (973) 377-8750 or +353 21 432 0050, fax (973) 377-8687, e-mail:
[email protected], www.qumas.com
Adapt~EDC Clinical Trials Suite See Data Collection/
CAPAcompliance QUMAS provides enterprise compliance
106, Horsham, PA 19044, USA, (919) 674-8174, fax (919) 674-8146, e-mail:
[email protected], www.araccel.com
TrialMaster See Data Collection/Management
Propack Data Corp. PMX CTM Solution See Trials Management/
management solutions for regulated companies. QUMAS solutions allow companies to effectively secure, manage, and distribute regulatory information in compliance with the latest FDA and international regulations, including 21 CFR 11. QUMAS solutions are finished applications and are delivered with validation, training, and rapid-deployment services.
DocCompliance QUMAS provides enterprise compliance management solutions for regulated companies. QUMAS solutions allow companies to effectively secure, manage, and distribute regulatory information in compliance with the latest FDA and international regulations, including 21 CFR 11. QUMAS solutions are finished applications and are delivered with validation, training, and rapid-deployment services.
Management
Araccel Corporation 120 Gibraltar Rd., Ste.
Araccel Solutions Platform Araccel Corporation is a biomedical information technology company that provides integrated enabling technology solutions to the pharmaceutical industry. Araccel develops and markets e-R&D pharmaceutical software and system solutions that capture and clean clinical data, improve processes and provide metric reports on clinical trial data for enhancing and accelerating drug development.
Axio Research Corporation Internet-based data management services See Data Collection/Management
BioObjects, Inc.
Management
tory biometry and technology management (e.g., IVRS and Internet combined) constitutes Cardinal systems’ guarantee to manage your clinical data in the most secure way. Cardinal systems’ Internet applications DBMSuite and CRFSuite are dedicated to CRF design, investigator data entry, monitoring, data management, and safety reporting.
Records Manager for Lotus Notes Mail See Knowledge Management
Winchester Business Systems, Inc. 50 Cross St., Winchester, MA 01890, USA, (781) 7297150, fax (781) 729-7211, e-mail:
[email protected], www.wbsnet.com
CB Technologies, Inc. 350 Eagleview Blvd., Exton, PA 19341-1155, USA, (610) 280-7400, fax (610) 280-0440, e-mail:
[email protected], www.cbtech.com MetaTrial CB Technologies is the premier provider of
Development
technology tools and services to the life science industries. CB’s solutions include MetaTrial clinical electronic data capture software and myMetaTrial Management Portal. These innovative solutions enable greater efficiencies in the clinical trials process. For more MetaTrial information, visit www.metatrial.com.
Health Agency Tracking The Health Agency Tracking
ClickFind MED
system tracks documents associated with queries and responses made by and to regulatory agencies. Automatic workflow notifies all project team members and initiates action items for resolution of the query. Maintains complete audit trail. Conforms to 21 CFR 11 regulations for electonic records and signatures.
ClickTrials See Web-Based Software Services
adWatch See Adverse Events Custom application development See Custom Application
paraFILE paraFILE helps users capture, author, edit,
50
North Cambridge, MA 02138, USA, (617) 520-6609 or (617) 494-5590, fax (617) 494-5589, e-mail: info@ crfbox.com, www.crfbox.com
CRF Box Wireless CRF Box Wireless is the first electronic subject diary solution utilizing multiple platform technology. This allows multiple end-terminals, high data security, and flexible integration to existing IT infrastructure. The technology accelerates trial completion, encourages protocol compliance, and enhances therapeutic claims, allowing communication of a drug’s value to the medical marketplace.
DataLabs DataLabs CTMS See Clinical Project Management
Datapharm Australia Pty. Ltd. 56-56A Thompson St., Drummoyne, NSW 2047, Australia, +61 2 9719 2800, fax +61 2 9719 2811, e-mail: info@ datapharm.com.au, www.datapharm.com.au
eCRF eCRF is a remote data capture tool allowing sites
Datasential LLC 440 Getty Ave., Clifton, NJ
CRFSuite and DBMSuite Five years of expertise in regula-
Capture (EDC)
CRF Box U.S. 124 Mt. Auburn St., Ste. 20026,
DataScout Software, Inc.
iKnow—New Product Launch See Knowledge
Valid Systems Incorporated
12033 Stockholm, Sweden, +46 8 643 4270 or +358 40 560 8189, fax +46 8 5560 9340, e-mail: info@ crfbox.com, www.crfbox.com
75011 Paris, France, +33 1 40 21 19 07, fax +33 1 40 21 94 95, e-mail:
[email protected], www. cardinal-sys.com
Cardiff Software, Inc.
StudyBuilder Enterprise Edition See Electronic Data
CRF Box Scandinavia Hammarby Fabriksväg 23,
Cardinal systems 91 avenue de la République,
ance management solutions for regulated companies. QUMAS solutions allow companies to effectively secure, manage, and distribute regulatory information in compliance with the latest FDA and international regulations, including 21 CFR 11. QUMAS solutions are finished applications and are delivered with validation, training, and rapid-deployment services.
StudyBuilder B.V.
Tammasaarenkatu 5, 180 Helsinki, Finland, +358 201 700 70 or +358 201 700 740, fax +358 201 700 710, e-mail:
[email protected], www.crfbox.com
LiquidOffice See Electronic Submissions TELEform See Data Collection/Management
Web Services See Web-Based Software Services
iWorksite See Knowledge Management
CRF Box Ltd.—Headquarters
to send clinical trial data electronically to Datapharm’s secure server. Fields are programmed with edit checks and database lookups allowing quick access to clean data that can be viewed on the Web. System setup and maintenance is cost-effective.
e-DocCompliance QUMAS provides enterprise compli-
Skila, Inc.
CRF Box Central Europe Vinohradska 184, 13052 Prague 3, Czech Republic, +420 2 6713 2764 or +420 602 669 062, fax +420 2 6713 2765, e-mail:
[email protected], www.crfbox.com
Clinical DataFax Systems Inc. DataFax See Data Collection/Management
ClinicalTrialsNet Inc. ClinTriNet See Web-Based Software Services
IVRQuest See Clinical Project Management 07011, USA, (866) 840-2202 or (201) 655-5005, fax (973) 478-0037, e-mail:
[email protected], www.datasential.com
TrialOne Services TrialOne is a turn-key, Web-based, outsourced solution for gathering clinical trial data. Providing solutions for investigator sites, subject diary data, and lab reports. Offering features and functionality not found anywhere else in the EDC marketplace. Realize the full potential of EDC with TrialOne by Datasential.
DATATRAK Deutschland, GmbH Am Propsthof 80, 53121 Bonn, Germany, +49 228 979 8330, fax +49 228 979 8334, e-mail: contact@ datatraknet.com, www.datatraknet.com
DATATRAK International, Inc. 20600 Chagrin Blvd., Ste. 1050, Cleveland, OH 44122, USA, (216) 921-6505, fax (216) 921-6702, e-mail: contact@ datatraknet.com, www.datatraknet.com DATATRAK EDC DATATRAK International, Inc., with offices in Cleveland, OH, and Bonn, Germany, specializes in electronic data capture using DATATRAK EDC. The product suite operates in centralized or stand-alone modes, and offers state-of-the-art security and real-time data entry and review. Electronic site-assessment, Webbased training offered.
Dendrite International, Inc. 1200 Mt. Kemble Ave., Morristown, NJ 07960-6797, USA, (732) 246APPLIED CLINICAL TRIALS
August 2001
8518 or (973) 615-9369, fax (732) 745-8737, e-mail:
[email protected], www.dendrite.com
eClinical Global Deployment Facilitators Dendrite is a software and hardware independent facilitator of e-clinical program implementation for hardware deployment, help desk, Web-based training, IVRS voice recognition for subject randomization and diaries and short CRF data entry, adverse event management and reporting, site and subject recruitment, to save time and cost to market.
Document Control Systems, Inc. MASTERControl FDA Edition See Document Management
eResearchTechnology, Inc. 1150 Route 22, East Bridgewater, NJ 08807, USA, (908) 704-8010, (908) 704-8010 ext. 134, fax (908) 541-0091, e-mail:
[email protected], www.ert.com
SMART Patient Diary Card We are an international company leading the way in EDC from clinical trials. Our product ALPHADAS uses smartcards in order to comply with GCP and FDA 21 CFR 11 on the archival of source data. ALPHADAS can be used across all areas of clinical research for remote or direct data collection.
MAJARO InfoSystems Inc. ClinAccess Casebook See Data Collection/Management ClinAccess Dictionary Coder See Data Collection/ Management
ClinAccess PowerServer See Data Collection/ Management
ClinAccess SureStart See Data Collection/Management ClinAccess Web Component See Data Collection/ Management
eResearch Network and Community Technologies
MarCon Global Data Solutions, Inc.
eResearchTechnology, Inc. (eRT) is a provider of integrated Web-based technology products and services to the biotechnology, pharmaceutical, and medical device industries. eRT can streamline the conduct of a study by transforming it from a manual paper-based system to an electronic process of data collection, analysis, and reporting. eRT also provides centralized collection and interpretation of electrogradiographic information.
See Clinical Project Management
First Consulting Group FirstDocs for CRFs See Document Management
FW Pharma Systems INITIATOR See Trials Management/Administration
Health Care Online, Inc. PO Box 6524, Annapolis, MD 21401, USA, (410) 897-9509 or (410) 897-9080, fax (410) 510-1984, e-mail:
[email protected], www.hcol.com
HCOL Clinical Study Enterprise Edition HCOL Clinical
NetRegulus One Tower Lane, Ste. 1700, Oakbrook Terrace, IL 60181, USA, (888) 707-6900, fax (630) 573-6050, e-mail:
[email protected], www. netregulus.com ActivityExpert ActivityExpert is an entirely Web-based solution that enables any authorized person to input information into NetRegulus’ PQIntelligence Software System. It is ideal for vendors, field representatives, auditors, clinical trial personnel, and others who require limited access to the system’s functionality. User training is not required for this Web-based module.
IssueExpert See Adverse Events PQIntelligence See Knowledge Management RegistryExpert See Data Collection/Management StudyExpert See Trials Management/Administration TrackExpert See Data Collection/Management
StudyBuilder Enterprise Edition StudyBuilder Enterprise Edition ($4999/study designer; no site/subject/data manager fees) integrated study design, data management and collection package. Use wizards and drag-anddrop to design and deploy your study. Includes data collection/management system for Web, palmtop, and desktop computers and integrates data from spirometers, etc., automatically.
TEAMworks Clinical Services 1 Farnham Rd., Guildford, Surrey GU2 5RG, UK, +44 1483 549 019, fax +44 1483 549 119, e-mail:
[email protected], www.teamworks.de
TRIALink EDC Systems TEAMworks was founded in 1997 following successful introduction of our Internet-based TRIALink electronic data capture (EDC) system. The TEAMworks organization has since established itself as a leading EDC innovator and vendor with experience in the implementation, deployment, and support of e-clinical trials across all phases and international geographies. With offices in Switzerland, the UK, Germany, Singapore, and USA, TEAMworks is also establishing itself as a global leader in applying innovative Internet technologies together with high performance processes to automate the clinical trial process.
Valid Systems Incorporated Records Manager for Lotus Notes Mail See Knowledge Management
Vitalograph Ltd. Maids Moreton, Buckingham, Buckinghamshire MK18 1SW, UK, +44 1280 827120 or +44 1280 827107, fax +44 1280 823302, e-mail:
[email protected], www.vitalograph.co.uk
Electronic PEF/FEV1 Diary Vitalograph has been a world leader in respiratory diagnostics for almost 40 years. The Centralized Spirometry System transmits encrypted data every day via e-mail from investigator sites direct to the sponsor or via a dedicated and unique over-read software system where data quality is ensured on a daily basis.
Study Enterprise Edition takes advantage of the efficiencies of the Web, wireless, PDAs, and touch-screen PCs to accelerate the capture of clinical data. Our system allows both clinicians and subjects to enter data anywhere. Studies can be monitored remotely in realtime and managed cost-effectively.
Numoda Corporation
INC Research Collection/Management
Waltham, MA 02451, USA, (888) 703-1122 or (781) 890-7878, fax (781) 890-4848, e-mail: info@ phaseforward.com, www.phaseforward.com
been a world leader in respiratory diagnostics for almost 40 years. The first of its kind, this PC Spirometry system enables investigators to click on an e-mail button to transmit encrypted data over the Internet. Optional and unique over-reading software ensures highquality data on a daily basis.
InferMed Limited 23 Bedford Square, London
InForm Phase Forward’s InForm provides the first
Winchester Business Systems, Inc.
WC1B 3HH, UK, +44 20 7269 3708 or +44 20 7269 3708, fax +44 20 7269 3716, e-mail: infermed@ infermed.com, www.infermed.com
completely integrated clinical data management solution that leverages the power of the Internet to accelerate the clinical trial process and helps to ensure rapid database lock and facilitate FDA approval. Using any Web browser, InForm offers security and scalability with minimal training efforts.
adWatch See Adverse Events Custom application development See Custom Application
Clinical Drug Development Services See Data
MACRO MACRO is an application based on core propri-
Numoda mTrial See Wireless/Mobile Technologies
OmniComm Systems, Inc. TrialMaster See Data Collection/Management
Phase Forward Incorporated 1440 Main St.,
Spirotrac Centralized Spirometry System Vitalograph has
Development
Health Agency Tracking See Document Management paraFILE See Document Management Protocol Manager See Clinical Project Management
etary technology. It is a modular system for running Internet-based multicenter trials. MACRO’s intuitive, interactive tools for remote study definition, online and off-line remote data entry, and remote study monitoring reduce set-up time and improve time to database closure.
PHT Corporation 500 Rutherford Ave., Charlestown, MA 02129, USA, (617) 973-1600, fax (617) 973-1601, e-mail:
[email protected], www.phtcorp.com
invivodata, inc.
Esendant Clinical Network Esendant Clinical Network
invivosystem See Data Collection/Management
Center Dr., Temecula, CA 92591, USA, (800) 843-7477, fax (800) 418-4333, e-mail:
[email protected], www.lifetree-tech.com
collects, processes, and archives data used in development, approval, and marketing of pharmaceuticals. Unique Web EDC system architecture based on XMLbased open data model consistent with CDISC standards, yielding easy integration with legacy systems plus ready system expansion. Palm-based LogPad subject diary offers true e-source.
Collection/Management
Propack Data Corp.
BioObjects, Inc.
PMX CTM Solution See Trials Management/
Web Services See Web-Based Software Services
LifeTree ICTM LifeTree ICTM is a comprehensive Internet-
Administration
based solution that accelerates trials, setting the standard for trial data management. ICTM’s Web-based system simplifies study design and data management, automates electronic case report forms (eCRFs) and accelerates data entry and validation. ICTM answers the demand for exceptional data management.
SAM GmbH Huettenstr. 7, D-52068 Aachen, NRW,
Cardiff Software, Inc. 3220 Executive Ridge Dr., Vista, CA 92083, USA, (760) 936-4500, fax (760) 936-4800, e-mail:
[email protected], www.cardiff.com
Kronos Communicated Data, Inc. APERS See Custom Application Development OutcomesCall See Custom Application Development
LifeTree Technology, LLC 41093 County
Logos Technologies Ltd. Chiltern House, Feathers Yard, Basingstoke, Hampshire RG21 7AT, UK, +44 1256 478900, fax +44 1256 473332, e-mail: info@ logostechnologies.com, www.logostechnologies.com
ALPHADAS We are an international company leading the way in EDC from clinical trials. Our product ALPHADAS uses smartcards in order to comply with GCP and FDA 21 CFR 11 on the archival of source data. ALPHADAS can be used across all areas of clinical research for remote or direct data collection.
52
Germany, +49 241 8882103 or +32 87 789120, fax +49 241 8882100, e-mail:
[email protected], www.SAM-Germany.de
ars RDE system Windows NT and 2000–based, unlimited number of checks/crosschecks. ars meets all FDA RDE requirements; ars monitoring modules support source data verification, modem-based transfer of data, automatically PGP-coded, from trial centers via RDE server to monitors, drug safety, DM/biometric departments, interfaces to electronic (e.g., blood pressure) devices.
StudyBuilder B.V. Postbus 177, 1000 AD Amsterdam, The Netherlands, +31 71 514 2988, fax +31 71 514 2986, e-mail:
[email protected], www.studybuilder.com
Zurich Biostatistics, Inc. Tekoa XML Technology See Data Collection/Management
Electronic Submissions Axio Research Corporation Internet-based data management services See Data
LiquidOffice The LiquidOffice eForm Management System is a complete XML-based solution that is used to automate forms and the business processes they drive. LiquidOffice uses XML, HTML, and Adobe PDF standards to put forms into an online system— complete with routing, online approval, digital signatures, and data processing.
Cardinal systems CRFSuite and DBMSuite See Electronic Data Capture (EDC)
CDC Solutions Inc. 6 Tower Bridge, Ste. 440, 181 Washington St., Conshohocken, PA 19428, USA, (610) 834-9021 or (610) 834-4212, fax (610) 8349023, e-mail:
[email protected], www. cdcsolutions.com APPLIED CLINICAL TRIALS
August 2001
EZsubs EZsubs from CDC Solutions provides unparal-
Cardinal systems
leled document assembly, delivery, and publishing solutions for the process of publishing complex regulatory documents and submissions. EZsubs is a highly scalable publishing solution capable of handling submissions to regulatory agencies, ranging in size from small Biologics License Applications (BLAs) to New Drug Applications (NDAs).
CRFSuite and DBMSuite See Electronic Data Capture
CRF Box
DataCeutics, Inc. 1610 Medical Dr., Ste. 300, Pottstown, PA 19464, USA, (610) 970-2333 or (610) 970-4050, fax (610) 970-4884, e-mail: info@ dataceutics.com, www.dataceutics.com
CRF Box Wireless See Electronic Data Capture (EDC)
DataCeutics, Inc. Clinical Information Technology Consulting See IT
(EDC)
CB Technologies, Inc. MetaTrial See Electronic Data Capture (EDC)
ClickFind MED ClickTrials See Web-Based Software Services
BBK Healthcare, Inc. 320 Needham St., Ste. 150, Newton, MA 02464, USA, (617) 630-4477, fax (617) 630-5090, e-mail:
[email protected], www.bbkhealthcare.com TrialCentral.net With TrialCentral.net, BBK connects clinical teams, regulatory groups, investigators, and their staffs, outsource suppliers, and study participants in a “virtual community,” improving operational efficiency and ultimately accomplishing trial recruitment and retention goals. The application is compatible with the wide range of telemanagement and EDC systems currently in the marketplace.
Biostat, Inc.
Electronic Data Capture (EDC)
Clinical Information Technology Consulting DataCeutics is the leader in clinical information technology support and services for clinical, data management, and biostatistical teams. Primary services are clinical data management and clinical reporting consulting, electronic submission support, ASP service, migration, outsourcing, validation, and 21 CFR 11 compliance.
First Consulting Group
DataLabs
CompleWare Corporation
FirstDocs for CRFs See Document Management
DataLabs CTMS See Clinical Project Management
WebCRF See Electronic Data Capture (EDC)
iBiomatics
First Consulting Group
Document Control Systems, Inc.
P21 Biomedical Knowledge Platform See Data Ware-
FirstDocs for CRFs See Document Management
MASTERControl FDA Edition See Document Management
housing
Health Care Online, Inc.
eResearchTechnology, Inc.
Consulting
Document Control Systems, Inc. MASTERControl FDA Edition See Document Management
eResearchTechnology, Inc. eResearch Network and Community Technologies See
INC Research
Comprehensive Meta Analysis See Statistical Analysis
CB Technologies, Inc. MetaTrial See Electronic Data Capture (EDC)
CDC Solutions Inc. EZsubs See Electronic Submissions
HCOL Clinical Study Enterprise Edition See Electronic
eResearch Network and Community Technologies See
Clinical Drug Development Services See Data
Data Capture (EDC)
Electronic Data Capture (EDC)
Collection/Management
First Consulting Group
Services
Intrasphere Technologies, Inc. 100 Broadway, 10th Floor, New York, NY 10005, USA, (212) 9378200, email:
[email protected], www.intrasphere. com
LifeTree Technology, LLC
Systems Integration Intrasphere Technologies provides
LifeTree ICTM See Electronic Data Capture (EDC)
technology consulting and systems integration for EDC, clinical trials management, safety and pharmcovigilance, e-intelligence, document management, corporate finance, and enterprise information portals.
iBiomatics
IntraLinks, Inc. IntraLinks digital workspaces See Web-Based Software
MAJARO InfoSystems Inc. ClinAccess Casebook See Data Collection/Management ClinAccess Dictionary Coder See Data Collection/ Management
ClinAccess PowerServer See Data Collection/ Management
ClinAccess SureStart See Data Collection/Management ClinAccess Web Component See Data Collection/ Management
NetRegulus ActivityExpert See Electronic Data Capture (EDC) IssueExpert See Adverse Events PQIntelligence See Knowledge Management RegistryExpert See Data Collection/Management ReportExpert See Data Mining and Visualization StudyExpert See Trials Management/Administration TrackExpert See Data Collection/Management
OmniComm Systems, Inc.
Logos Technologies Ltd.
Insightful Corporation
ALPHADAS See Electronic Data Capture (EDC) SMART Patient Diary Card See Electronic Data Capture
Analysis
IntraLinks, Inc.
Propack Data Corp.
Services
PMX CTM Solution See Trials Management/ Administration
SEC Associates, Inc. Computer system compliance consulting See Validation
StudyBuilder B.V. StudyBuilder Enterprise Edition See Electronic Data Capture (EDC)
Winchester Business Systems, Inc.
Management
Winchester Business Systems, Inc.
Zurich Biostatistics, Inc.
Development
Tekoa XML Automation Technology See Statistical Analysis
Tekoa XML Technology See Data Collection/Management
Health Agency Tracking See Document Management paraFILE See Document Management Protocol Manager See Clinical Project Management
Zurich Biostatistics, Inc.
Authentica, Inc. 170 Tracer Lane, Waltham, MA
Analysis
02451, USA, (781) 487-2600, fax (781) 290-0424, e-mail:
[email protected], www.authentica.com
Araccel Corporation Araccel Solutions Platform See Electronic Data Capture (EDC)
BioObjects, Inc. Web Services See Web-Based Software Services
54
IntraLinks digital workspaces See Web-Based Software
Invantage, Inc. Investigator DataWeb System See Trials Management/ Administration
LifeTree Technology, LLC LifeTree ICTM See Electronic Data Capture (EDC)
NetRegulus One Tower Lane, Ste. 1700, Oakbrook Terrace, IL 60181, USA, (888) 707-6900, fax (630) 573-6050, e-mail:
[email protected], www. netregulus.com ActivityExpert See Electronic Data Capture (EDC) PQIntelligence PQIntelligence is the smart, 21 CFR 11–compliant software system that provides enterprisewide, Web-enabled data management specifically for the medical products industry. Working in the background, PQIntelligence organizes, automates, and manages clinical, regulatory, and other product data, while you focus on what you do best: developing and marketing your product.
ReportExpert See Data Mining and Visualization TrackExpert See Data Collection/Management
Numoda Corporation
Knowledge Management
Tekoa XML Automation Technology See Statistical
IT Consulting
S-PLUS and SeqTrial, Server Products See Statistical
(EDC)
Health Agency Tracking See Document Management paraFILE See Document Management Product Complaint Management See Adverse Events Protocol Manager See Clinical Project Management
adWatch See Adverse Events Custom application development See Custom Application
P21 Biomedical Knowledge Platform See Data WarePH.Clinical See Data Warehousing PH.Dataware See Data Warehousing
Development
Records Manager for Lotus Notes Mail See Knowledge
G23 Genomics Knowledge Platform See Data Warehousing
APERS See Custom Application Development OutcomesCall See Custom Application Development
StudyBuilder B.V. Valid Systems Incorporated
Clindex 2.0 See Data Collection/Management
housing
adWatch See Adverse Events Custom application development See Custom Application
Capture (EDC)
Fortress Medical Systems, Inc.
Kronos Communicated Data, Inc.
TrialMaster See Data Collection/Management StudyBuilder Enterprise Edition See Electronic Data
FirstDocs for CRFs See Document Management
MailRecall, PageRecall, NetRecall Authentica, Inc. provides information security software that lets businesses and organizations protect intellectual property and sensitive information throughout their lifecycle. With Authentica, users can dynamically control and manage their recipients’ use rights to information including the rights to view, print, copy, and forward information.
Numoda mTrial See Wireless/Mobile Technologies
QED Solutions, Inc. Qscan See Adverse Events
Skila, Inc. 1200 MacArthur Blvd., Mahwah, NJ 07430, USA, (888) 887-5452 or (201) 818-2277, fax (201) 818-5222, e-mail:
[email protected], www.skila.com iKnow—New Product Launch Skila’s integrated new product launch Web-based knowledge solution enables global product launch teams “to know,” “exchange knowledge,” and “take action” with internal (from clinical and manufacturing to marketing and sales) and external stakeholders to shorten time to market, increase the uptake curve, and increase revenues for new products. APPLIED CLINICAL TRIALS
August 2001
iWorksite Skila’s Web-based global business intelligence solution redefines how health care intelligence decisions are made through decision-enabling applications, market-based intelligence, and connectivity. Skila’s Intelligration technology synthesizes and transforms thousands of sources into succinct views of actionable business intelligence for smarter and more confident decisions.
Cardinal systems
SmarTest Systems supported: Windows 95/98/2000/
CRFSuite and DBMSuite See Electronic Data Capture
NT/ME. SmarTest: nonparametric multivariate analysis of multiple endpoints and repeated measures following the procedure of Wei and Lachin (1984): multivariate generalization of Wilcoxon-and-Logrank tests; two-group comparisons. Test for difference and equivalence/noninferiority, tests and confidence intervals.
StudyBuilder B.V.
DZS Software Solutions, Inc. 1661 Route 22 West, Bound Brook, NJ 08805, USA, (732) 764-6969, fax (732) 764-6755, e-mail:
[email protected], www.clinplus.com
StudyBuilder Enterprise Edition See Electronic Data Capture (EDC)
Valid Systems Incorporated 800 West
(EDC)
CompleWare Corporation WebCRF See Electronic Data Capture (EDC)
CRF Box CRF Box Wireless See Electronic Data Capture (EDC)
ClinPlus Coding See Web-Based Software Services ClinPlus Data Management See Data Collection/
Cummings Park, Ste. 6800, Woburn, MA 01801, USA, (781) 756-6200 or (781) 756-6226, fax (781) 7566220, e-mail:
[email protected], www.validsys.com
Management
Records Manager for Lotus Notes Mail The Valid Record
ClinPlus NDA Systems supported: Unix, Windows 95/NT,
Manager for Lotus Notes Mail is a complete solution for providing electronic recordkeeping to your e-mail. The product uses a folder-based interface for accepting records from e-mail, and then provides record classification and record lifecycle management. No modifications of the mail template are required.
Winchester Business Systems, Inc. adWatch See Adverse Events Custom application development See Custom Application Development
and SAS platform. DZS Software Solutions is the leader in SAS-based software solutions for clinical data management and reporting. The ClinPlus family of products enables your company to meet its goals in a timely and cost-effective manner.
ClinPlus Remote See Web-Based Software Services ClinPlus Report DZS Software Solutions is the leader in SAS-based software solutions for clinical data management and reporting. The ClinPlus family of products enables your company to meet its goals in a timely and cost-effective manner.
TESTIMATE 6.0 Systems supported: Windows 95/98/ 2000/NT/ME. TESTIMATE 6.0 offers exact tests based on a number of permutational algorithm and classical procedures. Descriptive statistics, ROC, ANOVA/ ANCOVA, and two-period crossover (bioequivalence), medical diagnostics, and nonparametric tests. P-values and confidence intervals, test for equivalence/noninferiority.
INC Research Clinical Drug Development Services See Data Collection/Management
Insightful Corporation 1700 Westlake Ave. North, Ste. 500, Seattle, WA 98109, USA, (206) 2838802 or (800) 569-0123, fax (206) 283-8691, e-mail:
[email protected], www.insightful.com S-PLUS and SeqTrial, Server Products Insightful Corporation provides software and services for statistics, predictive modeling, and data mining. Our products include S-PLUS, StatServer, and S-PLUS Analytic Server. Our data analytics help thousands of people understand reality and anticipate the future. Insightful’s consulting services provide modeling and development for CRM and business intelligence using Web-based analytics.
Health Agency Tracking See Document Management paraFILE See Document Management Product Complaint Management See Adverse Events Protocol Manager See Clinical Project Management
GraphPad Software, Inc. 5755 Oberlin Dr., Ste. 110, San Diego, CA 92028, USA, (858) 457-3909, fax (858) 457-8141, e-mail:
[email protected], www.graphpad.com
Zurich Biostatistics, Inc.
InStat InStat (Windows/Macintosh) conquers routine
Tekoa XML Automation Technology See Statistical
MAJARO InfoSystems Inc.
statistics by escorting you through analyses step by step. You’ll master the program in minutes—really. InStat is designed for analyzing small amounts of data, and is a perfect companion to more complex programs. Download a free InStat demo at www.graphpad.com.
ClinAccess Casebook See Data Collection/Management ClinAccess Dictionary Coder See Data Collection/
Management
StudyBuilder Enterprise Edition See Electronic Data
Prism GraphPad Prism (Windows/Macintosh) combines biostatistics, curve fitting, and graphing in one comprehensive program. Prism’s unique design helps efficiently analyze, graph, and organize experimental data. Prism helps you choose the right test and interpret the results. Download a free Prism demo at www.graphpad. com.
Capture (EDC)
Health Care Online, Inc.
Analysis
Tekoa XML Technology See Data Collection/Management
Medical Imaging Adapt~EDC, LLC Adapt~EDC Clinical Trials Suite See Data Collection/ Management
StudyBuilder B.V.
HCOL Clinical Study Enterprise Edition See Electronic
Statistical Analysis
Data Capture (EDC)
iBiomatics
Acumen Healthcare Solutions, LLC
PH.Clinical See Data Warehousing
TracIt2k EDC System See Electronic Data Capture (EDC)
idv Data Analysis & Study Planning Wesso-
Adapt~EDC, LLC Management
brunner Str. 6, 82131 Gauting/Munich, Germany, +49 89 8508001, fax +49 89 8503666, e-mail:
[email protected].
Analyse-it Software, Ltd. PO Box 77, Leeds
N Systems supported: Windows 95/98/2000/NT/ME.
LS12 5XA, UK, +44 113 229 5599, fax +44 113 263 2101, e-mail:
[email protected], www.analyse-it.com
N: planning and interpreting sample sizes. Event data (binomial test) or quantitative data (t-test). Target: sample size, beta, alpha, smallest detectable difference. Test for difference and equivalence/noninferiority. One sample and a constant, two correlated samples, parallel-group design, two-period crossover.
Adapt~EDC Clinical Trials Suite See Data Collection/
Analyse-it Clinical Laboratory Analyse-it! Method validation and evaluation software for Microsoft Excel. Includes NCCLS and IFCC protocols, Altman-Bland and NCCLS bias plots, Deming, Passing-Bablok, and Kappa method comparisons, NCCLS EP5imprecision, NCCLS EP6 linearity, IFCC reference ranges, ROC curves, and sensitivity and specificity analysis. Visit our web site to download a free trial.
Axio Research Corporation Internet-based data management services See Data Collection/Management
Biostat, Inc. 14 North Dean St., Englewood, NJ 07631, USA, (201) 541-5688, fax (201) 541-5526, e-mail:
[email protected], www.MetaAnalysis.com Comprehensive Meta Analysis Comprehensive Meta Analysis is a computer program for meta-analysis that combines ease of use with a wide array of computational options and sophisticated graphics. Power And Precision Power and Precision is a computer program for power analysis, to find the sample size required for a planned study. Work with confidence. Get the big picture in seconds. Present your results professionally.
August 2001
APPLIED CLINICAL TRIALS
Nnpar 1.0 Systems supported: Windows 95/98/2000/ NT/ME. Nnpar 1.0: planning and interpretation of studies concerning samples within the framework of the Wilcoxon-Mann-Whitney test. Target parameters: sample size, alpha, beta, and smallest detectable difference expressed as Mann-Whitney statistic P (X
