Richmond Pharmacology Integrated Trials Centre

Transcript

integrated trials centre richmond pharmacology Richmond Pharmacology Ltd St George’s University of London Cranmer Terrace, Tooting London, SW17 0RE T +44 (0)20 8664 5200 F +44 (0)20 8664 5201 E [email protected] www.richmondpharmacology.com Contents 04 Our goal 05 Our facilities 06 Our services 08 Volunteer recruitment 09 Patient recruitment 10 Meet the experts 03 Our goal An integrated solution to your Early Phase requirements ’Our goal is to deliver full service Early Phase clinical solutions swiftly, efficiently, and to the highest clinical standard. Our integrated set-up is designed to manage your Early Phase study within the controlled environment of Phase I. We compliment this through our out-patient facilities offering flexibility through the Early Phases in clinical trials. ‘Richmond Pharmacology is the UK’s only Early Phase Clinical Research Organisation (CRO) to conduct trials from within 2 acute NHS Teaching Hospitals. We are based within St George’sHospital, St George’s University of London, and Mayday University Hospital. Through our unique NHS Trust surroundings, we provide innovative Early Phase clinical and SMO (Site Management Organisation) solutions to 7 of the world’s top 10 pharmaceutical companies. ‘Finally, our on-site access to consultants across an unrivalled range of therapeutic areas ensures your study is designed and delivered to the highest clinical standard, from Protocol to Report.’ Dr Jörg Täubel, Managing Director, Richmond Pharmacology 04 Our facilities Unrivalled access to consultants, patients & Early Phase facilities The EU Clinical Trials Directive has enhanced the potential of the Phase I patient study into Early Phase clinical trials. To capitalise on this opportunity, Richmond Pharmacology has developed facilities based on our integrated ethos to deliver expertly managed, efficient and swift studies, within controlled and responsive acute NHS Trust settings. We have immediate on-site access to consultants across numerous specialties including: cardiology, respiratory, oncology, neurology, renal, dermatology and urology to reference just a few. This setting also provides access to 2 hospital patient populations covering an exceptional range of conditions. Within the hospitals, our accesscontrolled acute Phase I units feature 100 beds and 120 staff, with 24/7 hospital crash teams onsite. Our in-house clinical facilities provide additional control and support to protocol requirements and client requests. Our dedicated laboratories include a sample preparatory area, darkout blinds for photosensitive sample preparation, along with standardized equipment required for the preparation and storage of study samples. We maintain storage refrigerators and freezers of both −20°C and −70°C which are continuously monitored by the XJ500 alarm system. All lab and sample preparation activities are managed by experienced and trained laboratory personnel. Our custom-designed accesscontrolled pharmacies and drug preparation areas provide alarmed cold drug storage, incubation facilities and a controlled drugs cabinet. They are fully compliant with MHRA guidelines, allowing Richmond Pharmacology to repackage from bulk. Our on-site pharmacists are experienced in a number of drug preparation techniques and can cater to most protocol requirements. We host leading technology such as the sophisticated MUSE CV server and we are, to date, the world’s only CRO to have a networked ECG by every bed. We hold additional technology such as the Finometer for accurate capture and analysis of blood pressure and the wave form. Continuous monitoring is delivered through our Telemetry equipment. This expanding range of technologies is designed to optimize every stage of the clinical trial process. Richmond Pharmacology’s inhouse kitchens are manned by our fully qualified catering manager and her experienced team. We are able to provide a number of nutritionally balanced menus for an assortment of different study requirements, catering for young, elderly, Japanese, obese and varied patient populations. For client monitors, we have a number of dedicated rooms both within our office areas and attached to the wards providing our Clients with comfortable and private surroundings in which to work on site. Our in-patient facilities are set within spacious, open plan wards and include internet access, DVD’s, magazines, games consoles and volunteer lounges to relax and socialise with other volunteers. 05 Our services All encompassing, efficient and expertly run Our acute Phase I environment, in and out-patient facilities, leading technology and on-site therapeutic consultancy combine to offer a full service on any Early Phase study. Our Project Managers are life science graduates and provide you with a single point of contact to keep you updated on progress through each milestone. Protocol writing & CRF design To offer a full service, we can undertake both the CRF design and protocol writing for any study we take on. The protocol will be written by a team of Richmond’s experts including the Medical Director, Project Management, and our department of dedicated Medical Writers. In addition all data will be reviewed by our scientific advisory board which includes a toxicologist and clinical pharmacologists. Regulatory applications We undertake all regulatory matters on behalf of our sponsors, depending on your regulatory requirements. We 06 write and present the ethics submission and CTA application to gain regulatory approval for clinical studies from the relevant Ethics Committee and the MHRA. We attend ethics meetings and present all protocols to facilitate the efficient progression of your application through the regulatory process. First into man Based within the security of an NHS Hospital environment, we have extensive experience with both existing compounds and new chemical entities. This includes single and multiple dose studies, measuring tolerability and safety and a range of pharmacokinetic and pharmacodynamic assessments. We maintain NHS quality crash trolleys across our wards, with direct access to the hospital’s crash teams. QTc studies & Cardiac services We have a long standing relationship with the Department of Cardiac and Vascular Sciences within St George’s University London. Each bed has a dedicated MAC 1200 12-lead ECG machine, connected via a dedicated network to a MUSE CV server running the latest version GE-Marquette MUSE software. We support this state-of-the-art storage and ECG analysis system with our 16-channel telemetry unit and holter monitoring units. Through this expertise and technology, we offer our clients unparalleled cardiovascular expertise in the recording, manual interval measurement and analysis of ECGs. Bridging studies We are the largest provider of Japanese / Caucasian Bridging Studies in Europe. Our unique recruitment set up ensures a large panel of both Caucasian and Japanese volunteers. We have Japanese and Caucasian staff working together on all studies. Their understanding of both the culture and language ensure the safety and comfort of our Japanese volunteers and most importantly, guarantee accurate adverse events recording. Patient studies Our Integrated Trials Centre provides the foundations for Early Phase patient studies. Our Data management & statistics Our highly experienced team delivers procedures to ensure consistent highest quality data within set timelines, prompt and secure access to collected data, and a faster database lock, whilst satisfying regulatory requirements. We make use of the latest technology - Oracle Clinical Version 4.5 - which is considered to be the industry standard in Data Management. Oracle 4.5 is fully validated and FDA 21 CFR compliant. It facilitates database construction and swift, user friendly, accurate data lock and reporting. Data manipulation is performed using SAS 8.2 from predefined extract views in Oracle Clinical. We can provide specific Tables, Figures and Listings, Statistical Analysis Plans and Reports using SAS reporting. We also offer quick lock data capture in addition to conventional paper CRF. Medical writing Our professional, full time, in-house medical writing department produce clinical study reports with a comprehensive schedule, ensuring all aspects including integration, QC and review are well documented. Our writers are involved in the study through every stage to ensure a comprehensive understanding of the trial – consequently our reports are insightful and accurate. Delivery of your final, summarised data will be presented in paper copy as well as password-protected electronic files. We also provide stand alone report writing. We are specialists in QTc studies, Bridging studies, First into man, Patient studies, Data management, Medical writing, Drug free plasma acute NHS surroundings and in and out-patient facilities provide the sponsor with the option to include the control benefits of Phase I in their patient study. On-site access to relevant consultants and patient panels is supported by our background in pharmacological proficiency, all managed within our ‘one centre’ ethos to deliver a direct and efficient clinical solution. 07 Guaranteed panel delivery, on time and in budget We have set up an innovative and dedicated Volunteer Recruitment Department to provide you with a panel guarantee on every study conducted. Our team of professional marketers and recruiters is the UK’s largest in-house department of any Early Phase CRO in the UK. We blend innovative branding and marketing campaigns with traditional volunteer recruitment methods to deliver over 1,000 volunteer registrations every month. Our volunteer database is custom designed to sort volunteers demographically and enable instant access to the required volunteer panel. 08 We have extensive experience in delivering young, old and obese Caucasians. Our in-house Japanese recruitment team is recruiting the fastest growing Japanese panel in Europe. We have developed a detailed understanding of the Japanese community and our trials4japanese brand is the best known brand of its type. Our style of communication is tailored to the tastes and requirements of the Japanese community. Our Japanese Recruitment Project Managers are Japanese and bilingual to ensure effective communication with the volunteer panels. We have set up the largest dedicated volunteer recruitment department of any Early Phase CRO in the UK, and our database continues to grow at a rate of 1,000 new volunteers every month Volunteer recruitment Patient recruitment A three pronged solution through our integrated ethos Our integrated environment provides 3 foundations to effective and timely patient recruitment. Firstly, on-site access to consultants across 2 NHS Teaching Hospitals ensures expert advice on recruitment methods for specific panels. By involving these consultants during initial discussions on protocol design and feasibility, the method and timing of patient recruitment is identified and subsequently adhered to. Secondly, and through consultants’ recommendation, we have access to 2 hospital patient populations, covering an extensive range of conditions. Thirdly, our in-house Patient Recruitment Department operate within the same premises as the consultants and acts as a central point to efficiently co-ordinate the recruitment process. Furthermore, we have developed our trials4patients brand, promoted through nationwide marketing and advertising strategies that are rolled out dependent on the panel requirement. Our in-house department stores patient information in our custom designed volunteer database, according to criteria such as volunteer conditions and medications. This 3 pronged approach ensures we deliver patient panels on time, within budget, and across a multiplicity of therapeutic areas. 09 Meet the experts Dr Jörg Täubel is Managing Director of Richmond Pharmacology. To date he has been investigator in over 420 Phase I and Phase II studies in healthy volunteers in patients. His experience ranges from simple bioequivalence to complex pharmacokinetic and pharmacodynamic studies often administering compounds first in man. His particular interest is gastroenterology and bridging studies. Over the last 3 years, a large proportion of his work has been directly or indirectly related to these areas. New employees are put through a rigorous training and approval process by Richmond Pharmacology’s training department to ensure the highest standard of conduct for studies and the delivery of a quality service at all times. Prior to working in Clinical Pharmacology he worked in various clinical positions in different specialities both in hospitals and General Practice. Dr Jörg Täubel MD MFPM The people working at Richmond Pharmacology have extensive knowledge and expertise in every area of Early Phase clinical trials. Our three directors are all clinical pharmacologists and lead a dedicated, competent and motivated team of experienced managers and personnel. 10 Dr Täubel has been a speaker at numerous conferences on various topics with an emphasis on pharmacology, bioequivalence studies and volunteer recruitment in particular and is the author of numerous publications in scientific journals. Qualifications 1980 - 1987 Medical School at the Johann Wolfgang Goethe-Universität, Frankfurt am Main, Germany 1987 State Examination Medicine (German equivalent to the MB BS in the UK) and full registration as a Medical Practitioner (Approbation) awarded by the Hessisches Landesprüfungsamt für Heilberufe, Germany 1989 MD (postgraduate), awarded by the University of Frankfurt, Germany. Title of Thesis: “Follow-up on 128 female and male patients one to two years after transluminal coronary angioplasty.” 1999 Member of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom Clinical pharmacology experience From 2002 Managing Director Richmond Pharmacology Ltd 1995 - 2001 Medical & Managing Director Charterhouse Clinical Research Unit Ltd 1992 - 1995 Medical Director Phase II - IV Charterhouse Clinical Research Unit Ltd 1990 - 1992 Research Physician Phase I AFB - PAREXEL, Arzneimittelforschung GmbH, Frankfurt & Berlin 1987 - 1990 Senior House Officer Positions in various hospitals in UK & Germany Dr Radivoj Arezina is a founding director of Richmond Pharmacology. His responsibilities include running post-clinical services comprising cardiological sciences, quality control/monitoring, data processing and evaluation, medical writing as well as various aspects of business administration. Dr Arezina qualified in medicine at the Medical School of the University of Zagreb. Having spent one year in clinical medicine, in 1988 he joined the Institute for Medical Research and Occupational Health of the University of Zagreb where he worked under the stewardship of Prof. K Kostial. The focus of Dr Arezina’s attention at the Institute was chelation therapy for internal contamination with radionuclides and other toxic substances. Dr Radivoj Arezina MD MSc Thereafter, he worked as a medical writer and initially this was part of his responsibilities at a London-based CRO. During the three years leading to 2001, Dr Arezina was responsible for running its Phase I clinic. Over that period, the unit doubled in size to become one of the leading Phase I units in the UK and Europe. To date, Dr Arezina has been co-investigator on over 100 clinical trials ranging from bioequivalence to first into man and covering different therapeutic areas including cardiovascular, gastrointestinal, CNS, pain, dermatology, endocrinology and urology. Qualifications 1987 Degree in Medicine from Medical School, University of Zagreb, Croatia 1991 Master of Science Degree in Biomedicine from University of Zagreb, Croatia Clinical pharmacology experience From 2001 Research Director Richmond Pharmacology Ltd 2000 - 2001 Director of Phase I Clinic Charterhouse Clinical Research Unit Ltd 1998 - 2000 Assistant Director of Phase I Clinic Charterhouse Clinical Research Unit Ltd 1995 - 1998 Clinical Research Scientist Charterhouse Clinical Research Unit Ltd 11 Dr Ulrike Lorch is the Medical Director of Richmond Pharmacology. In this role she takes responsibility for the management of the clinic, planning and conduct of studies. Dr Lorch is a Fellow of the Royal College of Anaesthetists and has worked clinically in Anaesthesia, Critical Care and Pain Management. Dr Lorch has more than 7 years experience in conducting Clinical Pharmacology studies. She has been Principle/Chief Investigator in more than 60 studies at Richmond Pharmacology. Her experience ranges from bioequivalence studies to complex pharmacokinetic and pharmacodynamic studies including first into human studies. Special interests include pain, QTc, gastrointestinal and bridging studies as well as studies in elderly volunteers. Dr Ulrike Lorch MD MFPM FRCA In the conduct of specialist studies she frequently collaborates with experts in their respective fields. She is supported by Richmond Pharmacology’s Scientific Advisory Board. 00 12 Qualifications 1993 State Examination Medicine (German equivalent to MB BS in the UK) 1994 MD 2000 Diploma in Pharmaceutical Medicine 2001 Member of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom 2001 Fellow of the Royal College of Anaesthetists (UK) Clinical pharmacology experience From 2001 Medical Director Richmond Pharmacology Ltd 1995 - 1998 Physician Charterhouse Clinical Research Unit Clinical experience 2000 - 2001 Specialist Registrar South Thames West Anaesthetic Training Scheme at St. George’s School of Anaesthesia 1998 - 2001 Training in Anaesthesia/Critical Care and Pain Management 1993 - 1995 House Officer Positions in West London RICHMOND PHARMACOLOGY LTD Directors: Dr Jörg Täubel MD MFPM Dr Radivoj Arezina MD MSc Dr Ulrike Lorch MD MFPM FRCA Mr L Levine Mr M Z Levine Prof. BNC Prichard FRCP FACC FESC FFPM Scientific Advisory Board: (Chaired by Prof. BNC Prichard) Prof. P Anand MA MD FRCP Prof. J Kaski FRCP MD FACC Prof. A McLean BM BCh PhD FRCPath Richmond Pharmacology Ltd St George’s University of London Cranmer Terrace, Tooting London, SW17 0RE T +44 (0)20 8664 5200 F +44 (0)20 8664 5201 E [email protected] All information correct at time of printing www.richmondpharmacology.com 00 13 Richmond Pharmacology Ltd St George’s University of London Cranmer Terrace, Tooting London, SW17 0RE T +44 (0)20 8664 5200 F +44 (0)20 8664 5201 E [email protected] www.richmondpharmacology.com