GERMANY

Regulatory and Ethical Procedures

The requirements of Directive 2001/20/EC were fully implemented in August 2004. The clinical trial application must be submitted to the Federal Institute for Drugs and Medical Devices (BfArM) - or the Paul Ehrlich Institute (PEI) in the case of sera, vaccines, etc. The clinical trial protocol and other relevant documents must be attached. Concomitantly the vote of the Ethics Committee responsible for the residence of the investigator must be applied for. When a multicentre clinical trial is to be performed in Germany, a coordinating investigator ("Leiter Klinische Prüfung") must be appointed, who is responsible for the entire trial. His Ethics Committee will be the lead committee. The German Drug Act (AMG §67) requires that the authorities of the states (Laender) in which the clinical trial is to be conducted are also notified in advance. Health Care System The German health care system provides access to comprehensive high-quality health care for all residents. The system is financed for the most part by health care insurance payments. About 90% of the population are members of a statutory health insurance scheme. Membership is compulsory for all employees who earn less than a certain income and voluntary for those with higher incomes. About 10% of the population, mostly civil servants and the self-employed, are privately insured. For ambulatory medical care, patients are entitled to contact a general practitioner of their choice or go directly to a specialist. In order to keep health care affordable, health reforms are being put into effect. Facilities and services provided by ECRON in Germany Clinical Trials Management Our credo "Be ahead of guidelines" guarantees you the most advanced service into your team! Continuous training of our staff - both office-based and home-based employees - avoids the tendency of diverging in the interpretation of our voluminous SOPs. We have to keep control, because many people make up a team, and only one unified procedure makes a good trial! The Project Management consists of experienced academics who have all learned the job from scratch. They are familiar with all tasks comprised in a clinical trial, especially monitoring, and regular meetings to control ongoing trials ensure that time schedules and the budget are kept. Their deep insight in the organizational structure of your trial allows them to perform prospective troubleshooting, like the standard saying of the medical profession: Prophylaxis is the best treatment. Without the duties of day-to-day business our Medical Project Management can freely concentrate on all medical pitfalls of the ongoing project. Both trial protocol and CRF will be checked for correctness by a physician familiar with both clinical practice and pharmaceutical research. Project specific training intensifies the adherence to GCP procedures and broadens medical understanding. During data-cleaning procedures investigators are not bored by formal questions which do not contribute to the validity of the result. Take advantage of our Guideline Collection: Virtually all guidelines in clinical development are available as hard copy or alternatively as Word file. Each of your projects will be continuously checked against them in order to keep you updated or even to influence the continuation of the project. Monitoring to ICH Standard Full-time employment is a prerequisite to become an ECRON monitor, and a flawless track record to remain in the job. Maybe that is the reason why our team is so dedicated to take personal care of your project. Experienced monitors coordinate the trial. Tutorial visits on a regular basis maintain quality. In Germany, out of more than 6000 GCP-experienced sites to select from, we offer a wide choice of investigators with clusters in all main therapeutic areas. Regardless of recent experience, in any trial a feasibility study is to come first. We think that clinical research should not be an adventure. All senior monitors of ECRON who sat the ACRP exam passed it well above standard. Certified CRAs guarantee that your projects are being handled with utmost diligence. Leasing Personnel ECRON offers support in covering a short-term personnel shortage for any project you have got. Medical Devices in Research Our subsidiary CDR - Clinical Device-Research provides certified product development. Please contact ECRON headquarter for detailed information. ECRON academy Seminars assist you in training your people - academy Further Services Needed? For further services such as Medical Writing, Statistics, truly independent Quality Assurance etc, please refer to the relevant pages listed in the left frame or contact us. Local office/staff ECRON Hahnstr. 70, D-60528 Frankfurt/Main Phone: +49 (69) 66 80 30-0 Fax: +49 (69) 66 80 30-29 Email: headquarters@ecron.com VAT-Id-No. DE 812015618, AG Frankfurt/Main HR B 48657 Authorities Federal Institute for Drugs and Medical Devices (BfArM) Ministry of Health

Klaus D. Wiedey, MD President of ECRON