BioClinica Partners with NextDocs to Streamline Clinical Trial Submission Process
- Clinical Technology Integration to Deliver Regulatory Documents Faster -
DIA EuroMeeting 2012
March 23, 2012
NEWTOWN, Pa.--(BUSINESS WIRE)--BioClinica®, Inc. (NASDAQ: BIOC), a global provider of clinical trial management solutions, today announced its partnership with NextDocs, a leading global 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 industry-leading 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. "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."
Both BioClinica and NextDocs are Microsoft Gold-Certified partners. BioClinica has long been known for its industry-leading 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.
Follow BioClinica on the Trial Blazers blog at http://info.bioclinica.com/blog, and on Twitter at http://twitter.com/bioclinica.
About BioClinica, Inc.
BioClinica, Inc. is a leading global provider of integrated, technology-enhanced clinical trial management solutions. BioClinica supports pharmaceutical and medical device innovation with imaging core lab, internet image transport, electronic data capture, interactive voice and web response, clinical trial management and clinical supply chain design and optimization solutions. BioClinica solutions maximize efficiency and manageability throughout all phases of the clinical trial process. With over 20 years of experience and more than 2,000 successful trials to date, BioClinica has supported the clinical development of many new medicines from early phase trials through final approval. BioClinica operates state-of-the-art, regulatory-body-compliant imaging core labs on two continents, and supports worldwide eClinical and data management services from offices in the United States, Europe and Asia. For more information, please visit www.bioclinica.com.
About NextDocs Corporation
NextDocs is the global leader in providing Microsoft SharePoint-based compliance software solutions including quality management software, regulatory document management, and clinical portals. Its solutions enable businesses in regulated industries to achieve compliance with FDA and other agencies while automating processes, improving efficiency, and dramatically reducing costs. NextDocs customers include pharmaceutical companies, bio-techs, medical device companies, and CROs. For more information on NextDocs Corporation and the software solutions visit www.nextdocs.com.
Certain matters discussed in this press release are "forward-looking statements" intended to qualify for the safe harbors from liability established by the Private Securities Litigation Reform Act of 1995. In particular, the Company's statements regarding trends in the marketplace and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the consummation and the successful integration of current and proposed acquisitions, the timing of projects due to the variability in size, scope and duration of projects, estimates and guidance made by management with respect to the Company's financial results, backlog, critical accounting policies, regulatory delays, clinical study results which lead to reductions or cancellations of projects, and other factors, including general economic conditions and regulatory developments, not within the Company's control. The factors discussed herein and expressed from time to time in the Company's filings with the Securities and Exchange Commission could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance. You should review the Company's filings, especially risk factors contained in the Form 10-K and the recent Form 10-Q.
Company Contact - Jim Dorsey
Trade Media – Rachel Summers
Diccicco Battista Communications
Investor Contact - Michael Porter
Financial Media - Bill Gordon
Porter, LeVay & Rose, Inc.
NextDocs Contact -- Matt McLoughlin