In Medical Writing, a CRO creates all regulatorily relevant documents throughout the study lifecycle: the study protocol, Investigator’s Brochure (IB), Informed Consent Form (ICF), and IMPD during the start-up phase;

A Phase II study with 12 centers had to switch eCRF systems three weeks before First-Patient-In because the audit trail was not exportable. Study start: delayed by four months. Additional

Monday morning, 9:14 AM. A sponsor receives notification of a BfArM inspection scheduled for Thursday. The TMF index shows 340 missing documents. What follows is no longer preparation—only damage control.

Since January 31, 2025, the Clinical Trials Information System (CTIS) has been the mandatory EU-wide platform for the submission, assessment, and supervision of all clinical trials with human medicinal products

The overall regulatory responsibility for a clinical trial remains legally with the sponsor – even in the case of full outsourcing to a CRO. Monitoring, data management, statistics, and regulatory