Selecting the most suitable countries and sites for your clinical trial is a major step towards getting your study started off right. It also ensures a smooth study conduct. This becomes even more evident in view of the COVID-19 pandemic and its implications.
When considering running your study in the EU keep in mind this brings along many benefits. Generally, the EU has great social, cultural, ethnical & economic diversity. This means the incidences of different diseases and their prevalence rates are as equally diverse. From a sponsor perspective, this offers unique benefits in terms of finding the right study population and finding an acceptable risk-cost profile for your study.
Our Representative Services are designed to support you in finding the right European countries for your study. We provide you with the required expertise to ensure your study meets full regulatory compliance. We offer our regulatory expertise for both drug studies as a Legal Representative (acc. EU Regulation 536/2014) and medical device studies as an Authorized Representative (EU Regulation 2017/745). Additionally, we can represent you in the Non-EU countries of Switzerland and The United Kingdom.
To our understanding, legal Representative is an added value to your study and not seem as another mere financial burden. Legal Representative services should ensure:
- A smooth study conduct
- Regulatory compliance
- Cost-efficient rates
- Review of essential study data/documents,
- Effective communication with regulatory authorities
- Oversight to international sponsors (via eTMF/eISF)
- Review of the TMF and evaluate its inspection readiness, etc.
If you are in need of representation services, we are happy to support you.
Please click here to get in touch with us.
Benjamin Tsiflidis (btsiflidis@gcp-service.com)
Phone: +49 (0)421 89 67 66 15
