Can a CRO assist in preparing and submitting a clinical trial application in the CTIS system?
Yes — an experienced CRO not only can, but in practice should support the Sponsor in preparing and submitting a clinical trial application in the CTIS (Clinical Trials Information System). For many Sponsors, especially non-commercial ones, this process is demanding from a regulatory, operational and technical perspective. CTIS requires unified procedures, precise document formatting and strict adherence to deadlines — which is why professional CRO support significantly reduces the risk of errors and delays.
A CRO can take full responsibility for preparing the complete documentation package for Parts I and II of the application, including the protocol, IB, IMPD, patient materials and local documents. An important element of this support is the early identification of gaps or inconsistencies that could prolong the assessment process — the CRO’s experience allows these issues to be detected before the application enters the system.
A professional regulatory team within the CRO also coordinates the entire submission process: preparing the CTIS-compliant structure, uploading files in the correct formats, configuring system roles, managing communication with assessment bodies, and monitoring statuses, deadlines and any RFIs (Requests for Information). If regulators raise questions, the CRO helps prepare responses that meet required timelines and formal expectations.
Importantly, many CROs also support Sponsors after the application has been approved — handling amendments, updates, safety reports and managing the public part of the CTIS record, which is essential for study transparency.
For non-commercial Sponsors, who often lack an internal regulatory department, CRO support in CTIS means true workload reduction, shorter document preparation time and a lower risk of application rejection. Proper preparation and submission of the CTIS application is now the foundation for a smooth transition into the study execution phase — and a well-prepared CRO is the partner who provides comprehensive support throughout this process.
Do you have a study that requires CTIS submission and are unsure where to start? Our experienced clinical trial registration experts are here to help.
