WHAT WE OFFER FOR YOUR CLINICAL TRIAL APPLICATION

  • Submissions of Clinical Trials Phase I-IV as well as non-interventional trials in accordance with the EMA, FDA and other Regulatory Authority Regulations
  • Submissions of international trials are also made by local expert teams also aware of the local regulations and who works in collaboration with the study manager and the Start-up Specialist Team, responsible for the preparation of the core study regulatory package
  • Submission to National CAs and local ECs
  • Response to deficiency letters
  • Preparation and finalization of the financial agreements with study sites.
  • Preparation of non-substantive and substantive amendments in collaboration with the medical writing team
  • Notification to local authorities as required
  • Registration of Clinical Trials in EUDRA-CT and in any other national study database
  • Regular tracking of submission and approval status
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