Start Up

We offer a turnkey service, for a full range of Projects: Medical Clinical Trials, Medical Devices, Non-interventional Studies, Observational studies, Food/Food Suplements studies, and Epidemiologic studies among others.

Acitivites included are, among others:

  • Submission to Ethics Committees and Health Authorities (local & central).
  • EudraCT application, XML preparation.
  • Amendments.
  • Annual reports preparation and submission.
  • Site contracting negotiations.
  • Insurance Policy processing.
  • Preparation and obtaining of essential documentation.
  • Review and validation of translated documents.
  • Classification of observational studies by Competent Authority.
  • Feasibility and site selection for clinical trials, non-interventional studies, and market research.
  • Payment Management: patient payments, payment to centers/researchers.
  • Update Clinical Date Base.
  • Organization of investigator meetings.