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; protocol amendments, SAE narratives, and the Development Safety Update Report (DSUR) during implementation; and the Clinical Study Report (CSR), lay summaries according to EU CTR

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 costs: borne solely by the sponsor. The selection of an eCRF system determines GCP compliance, data integrity, and timely regulatory submissions, not IT budgets. Those

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. Inspection Readiness means that sponsors maintain their clinical trial in an inspection-ready state at all times: TMF complete, SOPs versioned and applied, training records current,

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 in the EU/EEA, in accordance with Regulation (EU) No. 536/2014. With the end of the three-year transition period, sponsors must manage all studies – new

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 submissions are transferable. However, participant safety, data integrity, and pharmacovigilance remain the sponsor’s responsibility. In practice, this separation between the delegation of tasks and liability