Non Interventional Studies
Non Interventional Studies (NIS) or post-marketing surveillance studies are an indispensable instrument in pharmaceutical research. Due to the fact that clinical Phase I-IV trials with pharmaceuticals provide us with a limited number of data within a selected study population we need high-quality post-marketing surveillance studies to receive more information about their use under real life conditions which reflects the medical routine practice. Hence reliable NIS data have a direct impact on the evolution of pharmaceuticals and therefore enhance the patients' safety.
GCP-Service conducts your NIS in Germany according to high quality standards based on following currently accepted principles:
- Recommendations of the Association of Research-based Pharmaceutical Companies (VFA) for the conduct of NIS (Jan, 2007)
- Recommendations of the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institute (PEI) (draft from May 2007)
- FSA codex (August 08) - German Drug Law (AMG, paragraph 67.6)
- Declaration of Helsinki where applicable - Good Clinical Practice where applicable
GCP-Service conducts NIS cost-efficient without losing sight of quality requirements. We offer for your NIS:
- High qualified CRAs
- 10-20% or more Source Data Verification
- Remote monitoring
- Preparation of Patient Informed Consent Forms and Investigational Plan
- Submission of Study documents to Ethical Committee and follow-up on approvals
- Valid Sample Size Calculation - Statistical Analysis and delivery of the Study Report
