BioClinica, a global provider of clinical trial management solutions, has partnered with NextDocs, a global provider of compliance solutions, to deliver solutions for easier access to clinical trial information and decrease the timeline for FDA submissions.
Through the strategic partnership, the two companies will integrate their solution products: BioClinica's OnPoint CTMS, which makes accessing, sharing, and analyzing operational data more efficient through the use of Microsoft SharePoint; and NextDoc’s eTMF, which provides customers a comprehensive document repository that simplifies the management of essential trial documentation and is compliant with the established Drug Information Association (DIA) reference model.
The unification of the systems creates a flexible workflow that reduces duplicate efforts and creates a seamless system for trial management and regulatory document routing.
For example, as new trial sites are qualified for trial participation in BioClinica OnPoint, NextDocs' eTMF will automatically create the required regulatory document lists for the site. As these documents are reviewed, they are automatically submitted into the NextDocs workflow where they are routed for review and approval, signed off electronically, and formatted for submission to the FDA.
OnPoint CTMS and NextDocs eTMF can also be deployed to the same SharePoint portal and sub-sites. This solution allows trial sponsors to access their study information through a single Microsoft SharePoint 2010 site. Trial managers can access eTMF documents, see document collection and approval status, and perform CTMS functions, such as review subject enrollment information and site monitoring reports, all in the same place.