TrialScope, the global leader in clinical trial transparency and compliance solutions, today announced general availability of the latest release of the PharmaCM platform (v.2.2) that automates and manages clinical trial results reporting via the European Medicines Agency's European Clinical Trials Database (EudraCT).
The new EudraCT results reporting functionality is a first-to-market solution that enables clinical trial sponsors to convert results data formatted for US National Institutes of Health registry (www.clinicaltrials.gov) 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 21 July 2014.
Mike Forgash, CEO, TrialScope, commented, "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 COO, added, "The EudraCT results reporting capabilities support sponsor internal processes for preparation, review and approval of clinical trial results prior to disclosing on the EudraCT website. This model enables sponsors to ensure the quality and accuracy of the data before making it available for public consumption via EudraCT."
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