USA – Experts offer CTIS advice on eve of transition for new applications

Many pharmaceutical companies in the EU are waiting on the sidelines to submit new clinical trial applications to the Clinical Trial Information System (CTIS) portal. Companies are either waiting for their colleagues to submit first or are waiting for last-minute technical glitches to be ironed out first, said an expert who recently spoke to Regulatory Focus on CTIS implementation.

Other experts told Focus that while the requirement to submit all new trials to CTIS is on 31 January, an ongoing challenge is submitting two sets of documents in the portal, one set of proprietary documents that cannot be released publicly and one set of non-proprietary information that can be published.

Another issue of concern is that local ethics committees are “struggling” with CTIS implementation amidst resource constraints and the information demands of the Clinical Trials Regulation (CTR). The experts also offered tips to ensure smooth implementation for submitting information to the portal…