CTIS and RFIs without stress – how to effectively manage communication with regulators?
The clinical trial assessment process in CTIS (Clinical Trials Information System) does not end with the submission of an application. One of the key stages of the regulatory procedure is handling Requests for Information (RFIs) from assessing authorities. The way, quality, and timeliness of responses often determine the speed of obtaining approval to start a study and the overall efficiency of the regulatory review process.
RFIs may concern various aspects of a project — from protocol content and informed consent documents, through participant safety, to methodological issues, data management, and compliance with EU Regulation 536/2014. Sponsors are given a strictly defined timeframe to respond, and missing deadlines may result in suspension of the procedure, re-evaluation of documentation, or even rejection of the application. In practice, the challenge lies not only in preparing responses but also in ensuring full consistency across medical, statistical, operational, and regulatory documentation.
An additional complexity is that communication within CTIS requires strict version control and precise assignment of responses to specific reviewer comments. Lack of proper coordination may lead to inconsistencies, duplication of information, or unintentional omission of regulatory queries, which can prolong the assessment process and increase the risk of additional rounds of questions.
CRO support in this area focuses on comprehensive management of communication within CTIS. This includes analysis of received RFIs, coordination of expert teams, preparation of scientifically and regulatorily aligned responses, document change control, and technical handling of system communication. As a result, sponsors avoid information chaos, and the response process becomes structured and aligned with regulatory expectations.
Experienced CROs also support sponsors before submission by identifying potential risk areas and anticipating regulatory questions based on prior project experience. This approach helps reduce the number of RFIs, shorten review timelines, and improve predictability of the clinical trial authorization process.
The Biostat team supports sponsors in ongoing CTIS communication, RFI response management, and coordination between medical, regulatory affairs, and biostatistics teams. This enables a smoother assessment process and allows sponsors to focus on strategic aspects of trial execution rather than complex regulatory communication.
If you are preparing a CTIS application or are already in the evaluation phase, CRO expert support can significantly increase your chances of obtaining approval quickly and efficiently, while minimizing delays related to regulatory communication.
