We provide full-service solutions for Phase I-IV clinical research and for medical devices. We have clinical experts in over 20 countries and experience in the following therapeutic areas: oncology, CNS, cardiovascular, infectious disease, immunology, rheumatology, pulmonology, endocrinology, gynecology, gastroenterology, nephrology, ophthalmology, urology and dermatology.
Legal Representationin EU and Switzerland
According to the EU Directive for Clinical Trials, Sponsors who do not have a legal residence in European Union or Switzerland must have a legal representative in order to conduct clinical trials. Legal representation service is covering, whilst not limited to:
- Interaction with the Competent Authorities and the Ethics Committees as the legal representative of the Sponsor;
- Assurance of smooth and timely communication with the professional bodies;
- Collection and storage of all Clinical Trial related information and documentation;
- Implementation of the Competent Authority decisions related to the Clinical Trial.
For any inquiry regarding our services, please contact Biomapas Business Development team.