Partnership for clinical trial solutions

NEWTOWN: BioClinica, Inc., a provider of clinical trial management solutions, announced its partnership with NextDocs, a provider of Microsoft SharePoint-based compliance solutions to life sciences organizations, 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,as per a release, intends to create 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.

“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. “Our competitive success worldwide, especially in Europe, demonstrates the value of collaborative partnerships like this that make BioClinica the clinical trial solutions provider-of-choice for top-tier pharmaceutical companies.”

“This partnership brings to the life sciences industry critical advances to simplify and accelerate business processes,” said Zikria Syed, Chief Executive Officer of NextDocs. “BioClinica is one of the top eClinical firms supporting global biopharmaceutical and medical device development, and we’re pleased to work with them. Together, we’ll help our mutual clients more effectively and efficiently manage clinical trial workflows.”