Veeva Systems just announced the availability of Veeva SiteVault Free, a free eRegulatory solution for clinical research sites.
The goal of the tool is to replace manual and paper-based regulatory processes by providing a modern cloud application to manage investigator site files in compliance with 21 CFR Part 11 in the Code of Federal Regulations and Health Insurance Portability and Accountability Act (HIPAA) requirements.
“Sites need resources and technology to help them get treatments to patients more quickly,” says Abbie Hosta, field marketing manager at Veeva. “Technology can help speed things up [in part] by streamlining data transmission times between sites and sponsors. It will improve quality, speed, and efficiency.”
“Understandably, a few sites have expressed healthy skepticism and have asked, ‘What’s the catch?’’’ says Bree Burks, vice president of site strategy at Veeva. “The answer is, there isn’t one. At the end of the day, the industry needs to speed product development to get new treatments to patients faster. We’re empowering sites with technology to achieve this goal.”
Veeva’s initiative is designed to “leave no site behind,” Burks says. “All sites should have an eRegulatory platform,” she adds, noting studies showing less than 20% of sites have internal “purpose built” systems in place.
Veeva says SiteVault simplifies regulatory document management and processes with capabilities such as electronic signatures, remote monitoring, certified copy workflows, and reporting. It can be used for all trials regardless of what technology sponsors are using, as well as the site file for investigator-initiated trials.
The tool supports an unlimited number of studies, documents, and users, and comes with customer support. It is also available in an enterprise edition, which is fully configurable and includes open application programming interfaces for integrations, customized reports, and tailored workflows.
Author: Michael Causey