BioClinica Partners with NextDocs to Streamline Clinical Trial Submission Process


Company News Release

BioClinica announced its partnership with NextDocs to deliver solutions that provide easier access to clinical trial information and decrease the timeline for FDA submissions. Through this strategic partnership, the two companies will extend integration that unites BioClinica’s OnPoint Clinical Trial Management System (CTMS) and NextDocs’ Electronic Trial Master Form (eTMF) products.

BioClinica’s OnPoint CTMS helps clinical trial sponsors and CROs to efficiently access, share, and analyze operational data by leveraging the power and ease of use of Microsoft SharePoint. NextDocs’ eTMF 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 these systems creates a highly 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.

“As a company focused on advancing the field of clinical research, BioClinica is excited to partner with a leader like NextDocs and bridge the gap between CTMS and eTMF systems,” said Peter Benton, BioClinica’s President of eClinical Solutions.

Both BioClinica and NextDocs are Microsoft Gold-Certified partners. BioClinica has long been known for its integration with Microsoft technology, harnessing the power of SharePoint and the Microsoft Office Suite to provide study project managers a comprehensive, real-time view into trial performance. NextDocs is the global leader in Microsoft SharePoint-based compliance solutions for life sciences organizations.

BioClinica will next demonstrate its eClinical solutions at DIA EuroMeeting March 26 – 28, 2012 in Copenhagen, Denmark at Booth 138. Recent releases of BioClinica’s OnPoint CTMS, Trident IWR, and Express EDC have experienced significant growth and adoption across the United States, Europe, and Asia, including multiple contracts with major European biopharma and research organizations.

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