V-Rooms Validated for Life Science Clinical Trial Document Management
The utilization of V-Rooms Virtual Data Rooms allows medical device and pharmaceutical
companies to accelerate medical advances to patients by providing a document management
tool to expedite the steps from discovery and/or design concept to commercial marketing.
Atlanta, GA (PRWEB) May 31, 2011 -- V-Rooms Virtual Data Rooms has completed accreditation of their
software solution in compliance with “FDA Code of Federal Regulations 21 Part 11 – Electronic Records;
Electronic Signatures” which defines the requirements for the creation, transmission and retrieval of electronic
documents associated with pre-clinical and clinical trials.
"The medical product development process for turning new laboratory discoveries into treatments or products
that are safe and effective is no longer able to keep pace with basic science innovation," said Karen Perkins,
President of V-Rooms. "Today’s translational research and clinical trial facilities are swimming in information
and drowning in documents. Critical changes are needed to improve this development process by establishing
and using new technological tools for document and data sharing, organization and management."
“Our V-Rooms have been assisting life science companies, including medical device, biotech and
pharmaceutical firms, in their fundraising and strategic partnering efforts for years,” said Dan Bradbary, CEO
of V-Rooms. “With our CFR 21 Part 11 validation, we can now provide a cohesive document management
solution for a secure, compliant and easy to use portal for clinical and preclinical documents generated during
the study process.”
V-Rooms Virtual Data Rooms fulfills a critical need for a central documents repository, rather than relying on
email, fax or courier of documents. Data Rooms fill this need for a technological tool that allows facility staff
members and key sponsor personnel to access all of a site’s documents residing in a central, real-time accessible
location. Different levels of user access determine what information is available to each user, complete with
automated audit trails detailing document usage.
The solution enables study directors, sponsors and facility team members to manage, organize and retrieve the
massive number of documents that are used by all members of the team during the study and then provides a
platform for the assimilation of final study findings. Reports that are generated and returned to a study sponsor
would shorten the amount of time needed for the clinical trial process, which translates into thousands and in
some cases, millions of dollars in cost savings.
Contact Information
Karen Perkins, President
V-Rooms
http://www.v-rooms.com
800-731-6379