TrialScope has announced general availability of the latest release of the PharmaCM platform v.2.2.
The platform 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 to the format required for EudraCT.
This approach reduces 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.
A requirement to report trial summary results became mandatory for sponsors from 21 July 2014.
TrialScope CEO Mike Forgash said: "We are releasing the EudraCT functionality in time for clinical trial sponsors to prepare to meet looming health authority disclosure deadlines throughout 2015."
TrialScope chief operating officer Thomas Wicks 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 website.
"This model enables sponsors to ensure the quality and accuracy of the data before making it available for public consumption via EudraCT."
To learn more about PharmaCM and TrialScope’s EudraCT results reporting functionality or to schedule a demonstration, contact firstname.lastname@example.org.