DIA Conference, Washington DC (26 June 2005)
Algorithmic Research, Inc. (ARX), a global provider of electronic signature and data security solutions, today announced that Beardsworth, a full-service Contract Research Organization (CRO) in Flemington, New Jersey has successfully deployed CoSign - ARX’s simple-to-use and tamper-evident electronic signature solution.
Beardsworth will be using CoSign to digitally sign various reports from Contract Research Administrators (CRAs) and Monitors at remote investigator sites as well reports from BCGINet – Beardsworth’s integrated, web-based clinical trials and 21 CFR Part 11-compliant data management system. Beardsworth quickly integrated CoSign with their various applications using ARX’s easy-to-use SAPI® (Signature API).
With this technology, Beardsworth will be able to improve the efficiency of delivering site visit trip reports to their clients. Regional staff will be able to electronically sign documents while traveling, eliminating delays and costs due to travel schedules and shipping of paper copies. In the future, Beardsworth plans to expand the use of this technology to increase efficiency and reduce paper in many other areas of their business operations.
Beardsworth has integrated the CoSign Digital Signature Solution directly into BCGINet to create a seamless interface with the existing features. Authenticated users can remotely sign trip reports and other database records from a standard web browser without any additional software, and with minimal training.
“The success of any software implementation relies on a solid technology base and a simple user interface.” said Steve Trigilio, Chief Technology Officer, Beardsworth. “Our programmers were able to focus more of their time on the end-user experience because they could rely on the CoSign appliance and the ARX technical staff to handle the complexities of the underlying signing process. By integrating the CoSign appliance directly into our Microsoft Active Directory user database we were able to reduce the complexity of the solution, and minimize password maintenance.”
CoSign’s PKI-based technology guarantees signer authenticity, data integrity, and non-repudiation of transcriptions. Regulations such as 21 CFR Part 11 dictate that biopharmaceutical organizations must implement an authentication system that ensures that electronic records and signatures are trustworthy, reliable and secure.
“CoSign electronic signatures allow CROs like Beardsworth to rapidly comply with FDA 21 CFR Part 11 and GXP requirements,” said Gadi Aharoni, CEO, ARX. “CoSign drives regulatory compliance while increasing business process efficiency. Cost savings are also achieved by reducing, or even eliminating, the time and cost of printing, handling, searching, and mailing paper-signed documents. Beardsworth needs to submit information to their biopharmaceutical clients under tight timelines. CoSign allows them to meet this goal by securely keeping these records in an electronic format for inclusion in clinical trial data records, and for ultimate submittal to the FDA”.
