DataLabs Announces Launch Of Site Manager(TM) 2.0, An Advanced Clinical Trial Management Portal Including Digital Signature Technology

PHILADELPHIA, June 19 /PRNewswire/ -- DataLabs, an innovative developer of Internet-based software applications for clinical development, today announced the launch of Site Manager(TM) 2.0 at the 42nd Annual Drug Information Association (DIA) Meeting. Advanced clinical trial software, Site Manager 2.0 improves the site selection and activation processes as well as overall site satisfaction with easy to use, web-based site management software. Site Manager 2.0 integrates CoSign(R), Algorithmic Research’s (ARX’s) electronic signature solution, enabling users to sign documents with secure, regulatory compliant, electronic signatures that complete the migration to paperless processes, further streamlining clinical trial efficiency.

Site Manager 2.0 is a communication portal that extends electronic data capture, allowing sponsors, clinical research organizations (CROs), investigator sites and other trial participants to streamline data exchange and entry, document processing and data management. With Site Manager 2.0, sponsors or CROs can quickly identify and initiate investigator sites and then monitor and administer the site during the course of the trial. Built on Microsoft’s SharePoint technology, Site Manager 2.0 meets CDISC ODM standards and complies with FDA 21 CFR Part 11.

“As our customers have embraced electronic clinical data management (eCDM) solutions, we saw the benefit of including technology that focuses on the numerous administrative activities surrounding the data management process,” said Nick Richards, COO of DataLabs. “By offering a secure collaborative solution that supports our industry’s strict regulatory requirements, we see Site Manager 2.0 as the next step in the realization of a true electronic trial management platform.”

For Site Manager 2.0, DataLabs focused on the collaboration components of managing, collecting and tracking documents and data. Site Manager 2.0 facilitates the communication and workflow to achieve the highest level of efficiency by streamlining processing and improving communication among clinical trial participants. Integrating CoSign electronic signatures enhances the entire process.

“SharePoint is a well-established and proven technology in the bio- pharmaceutical market, and Site Manager 2.0 is able to build upon it to provide features specific to clinical trial operations,” said Steve Shihadeh, general manager, healthcare and life sciences, Microsoft. “DataLabs’ transformative use of Microsoft technology provides seamless integration with desktop applications, enabling users to better connect and collaborate, ultimately allowing them to make more informed business decisions.”

“DataLabs seeks to extend online collaboration with sites beyond the capability of electronic data capture. We recognized an opportunity to enable eCDM to accomplish better communication more efficiently in the clinical trial market,” says Zikria Syed, VP Product Management & Collaborative Solutions at DataLabs. “Site Manager extends clinical trial management to a more integrally active process allowing clinical trial sites to access and update information dynamically, something that is not being done with any products on the market today.”

Pricing and Availability

Site Manager 2.0 is available now directly from DataLabs and will be sold as a perpetual license. Please contact DataLabs for more information.

About the Drug Information Association

With nearly 23,000 members worldwide, the Drug Information Association (DIA) is a professional association committed to the broad dissemination of information and improved professional practice. DIA serves its members by providing a neutral, global forum that promotes the exchange of information critical to professional performance and achievement. For further information, please visit www.diahome.org. DataLabs will be at booth #1829 at the DIA Annual Conference.

About DataLabs

DataLabs is an innovative developer of Web-based applications for clinical development that helps the CRO and biopharmaceutical industries accelerate clinical trials with proven software for eClinical Data Management, eCollaboration, and eLearning. Based on Microsoft platform technology, XML Web services and CDISC ODM standards, the DataLabs eClinical Solution product suite adapts to established operating procedures and integrates easily with existing technology systems. As a result, DataLabs’ customers enjoy a low total cost of ownership and high return on investment. Major pharmaceutical companies, government entities, healthcare organizations and contract research organizations (CROs) are currently realizing time and cost savings using DataLabs eClinical Solutions. DataLabs, a Microsoft Gold Certified Partner, is based in Irvine, Calif. with U.S. East Coast offices in Pennsylvania and a European office in the United Kingdom. For more information, please visit www.datalabs.com.

DataLabs

CONTACT: Sherold Barr, +1-503-595-5546, or sherold@extraordinarywork.com,for DataLabs

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