Non-interventional Studies

Non-interventional Studies (NIS) or post-marketing surveillance studies are an indispensable instrument in pharmaceutical research and the medical device industry. Due to the fact that clinical Phase I-IV trials with pharmaceuticals or medical devices 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 medical devices. However the budgets for these studies are usually very limited. This should no be the reason for poor quality. We are experts in running non-interventional studies. GCP-Service conducts NIS cost-efficiently without losing sight of quality requirements. We offer for your NIS:

  • Low cost eCRF solutions
  • Electronic Patient Reported Outcomes solutions (ePRO)
  • 5-20% or more Source Data Verification by experienced CRAs
  • Remote monitoring
  • Preparation of Patient Informed Consent Forms and Investigational Plans
  • Submission of study documents to Ethics Committee and follow-up on approvals
  • Valid sample size calculation - Statistical analysis and delivery of the Study Report

GCP-Service conducts your NIS with your product in Europe. We work 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

For medical device manufacturer we run small studies with CE marked medical devices to confirm the CE mark. If you have a CE marked medical device but you have problems with selling your products we can support your to receive a tool number (German: Hilfsmittelnummer) to get reimbursement.