Accreditation of Phase I units in the UK

Posted:
15
May 2007

15th May 2007May NewsletterAccreditation of Phase I units in the UKThere has been much debate following the adverse reactions to TGN1412 just over a year ago. Following the Duff report, draft guidelines on 'First-in-Man Clinical Trials' issued by the European Medicines Agency (EMEA) and the Medicines Healthcare Regulatory Authority (MHRA) are in public consultation.We welcome the introduction of the new and improved guidelines as part of the continuous evolution of clinical research. Whilst many, if not all of the proposed new guidelines should be good clinical research practice in quality clinical trial units, the introduction of these guidelines can only help to further enhance the UK's standing as leaders in the conduct of Phase I clinical trials.We have always positioned ourselves as market leaders within clinical research in the UK. Since the company's inception we have continuously evolved, striving for clinical excellence and the greatest possible care ensuring volunteer safety. Today Richmond Pharmacology, with two hospital based Phase I units, already fully meets the most stringent safety criteria that may be required by a potential accreditation scheme. Therefore, any scheme that is introduced will have no effect on our operations. Richmond Pharmacology will continue to function as usual with no anticipated changes to our processes, prices or timelines. This continuity of service should give our clients confidence that any work under way or due to begin during the introduction of the guidelines, will not be affected, ensuring Richmond continues to deliver clinical studies on time and in budget.The UK has the shortest regulatory approval timelines in Europe, with approvals received within 7 to 21 days. We also have an exceptional Ethics Committee approval system with well trained Ethics Committees who work to the same timelines as the regulatory agency. This efficiency, coupled with the clinical excellence the UK offers, will ensure the UK remains a global leader for First-Time-In-Man and other Early Phase trials in the years to come.As a stakeholder in the ongoing discussions about the forthcoming guidelines Dr Taubel is happy to field any questions regarding the accreditation of Phase I units in the UK. Indeed, if there is any other aspect of running your clinical trials in the UK that you may need further information on, please email Dr Taubel directly. Are you in the process of planning your outsourcing needs for the coming months?RPL is now accepting bookings for July onwards to conduct clinical trials from either one of our two Hospital based units. For all your full service Early Phase requirements including healthy or patient volunteers please contact Charlotte Gowling.Volunteer RecruitmentWe are very experienced at recruiting volunteers; maintaining a consistent level of recruitment of between 150 and 200 volunteers each month. However one of our sponsors expectations were greatly exceeded when we successfully recruited over 250 volunteers in 2.5 days for a medical device trial. The sponsor had scheduled over 10 weeks for recruitment!The volunteer recruitment team are going from strength to strength � and our volunteer database now stands at a massive 72,000 registered volunteers.If you have any questions on volunteer recruitment or would like to know how to access these volunteers for your studies email us.Pharma-Bio Outsourcing Conference & Exhibition10th & 11th July Savoy Place, London.The Pharma-Bio Outsourcing Conference and Exhibition is the premier forum for the discussion of developments in outsourcing strategies across the pharmaceutical research and development value chain.Supported by the United Kingdom Department of Trade and Industry (UKTI), London First and the Contact Clinical Research Association (CCRA), this is a must-attend event for everyone in the pharmaceutical outsourcing industry.Dr Rob Williams, Head of Drug Development Projects & Non-clinical Development, Cancer Research UK, has organised the world-class conference and has confirmed a number of highly regarded industry speakers including Dr Christopher Milne, Assistant Director of the Tufts Center in the US and Dr Jorg Taubel, Managing Director Richmond Pharmacology.If you are planning to attend this event, then Richmond Pharmacology contacts can enjoy a 10% discount on the delegate rate, to book your place or for more information visit http://www.pboec.com/.The Head of RPL's Data Management department applies the Richmond work ethic to his Marathon run!Adam Walker beat his personal best at this years Flora London Marathon; he completed the gruelling 26.2 mile run in just 4 hours 15mins and raised over £2,000 for the BLISS charity for premature babies.Richmond are proud to have such a committed head of department who always applies equal determination to all of his endeavors, both work and non-work related.The Data Management team at Richmond take great pride in delivering high quality data in time and on budget and consistently meet data base lock within two weeks from last patient last visit. In fact, Adam locked a database just 30 hours before beginning his 26.2 mile run through London! To find out more about the Data Management service email us.

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