Perform the application and approval process

Clinical research should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and are consistent with ICH-GCP and regulatory requirements (Dutch WMO). Before a trial is initiated an accredited IRB/IEC needs to approve a research project proposal. The multi-center procedure is especially complex and time-consuming.

Penthecilia has ample experience in submitting research protocols for approval. We will help you with both local and central review procedures.

Our services include:

  • Collecting all essential research documents
  • Application to the Eudract database
  • Digital submission to the CCMO (including ABR form)
  • Drafting cover letters
  • Drafting letters for family doctors
  • Supervising review procedures in the reviewing center
  • Supervising review procedures in local centers
  • Editing consent documentation
  • Answering any questions the review committee may have