TrialScope, a Jersey City, N.J.-based global provider of clinical trial transparency and compliance solutions, has made available the latest release of the PharmaCM platform (v.2.2) that automates and manages clinical trial results reporting via the EMA's European Clinical Trials Database (EudraCT).
The new EudraCT results reporting functionality is a first-to-market solution that enables trial sponsors to convert results data formatted for the U.S. NIH registry to the format required for EudraCT. This approach reduces the data entry effort for EudraCT results by up to 85% and applies preconfigured workflows and audit trails to the complex process of disclosing clinical trial results to the European registry. The requirement to report trial summary results became mandatory for sponsors as of July 21.
Mike Forgash, CEO of TrialScope, said, "The TrialScope team is working diligently to expand the PharmaCM platform. We are releasing the EudraCT functionality in time for clinical trial sponsors to prepare to meet looming health authority disclosure deadlines throughout 2015."
Thomas Wicks, TrialScope chief operating officer, said, "The EudraCT results reporting capabilities support sponsor internal processes for preparation, review and approval of clinical trial results prior to disclosing on the EudraCT web site. This model enables sponsors to ensure the quality and accuracy of the data before making it available for public consumption via EudraCT."