Veeva Systems has added remote monitoring capabilities to its SiteVault Free solution for source document review and verification in clinical trials. The technology is intended to facilitate easier, more effective sharing to accelerate study execution and improve trial quality.
SiteVault Free provides clinical research sites with a no-cost eRegulatory application so that they can manage study documentation. The additional remote monitoring capability enables study monitors to access, review, and collaborate on content online.
Bree Burks, Veeva Systems vice president of site strategy, told Outsourcing-Pharma that SiteVault Free stands out not just for its zero-dollar price tag, but for its functionality and the benefits it offers uers.
“SiteVault Free is a purpose-built eRegulatory system that replaces the need to rely on cumbersome paper or non-compliant shared drives and file share system to manage regulatory and source documentation,” she said. “It streamlines the management of documentation required to meet ICH-GCP and FDA requirements to improve efficiency and compliance.”
Burks added the solution features remote monitoring for both regulatory and source documents, and it supports 21 CFR Part 11 and HIPAA compliance. Additionally, it enables reports and dashboards that provide visibility into open tasks, upcoming expiration dates, and signature turn-around timelines; and workflows for eSignatures and certified copies.
Burks also told us that Veeva, recognizing the usefulness of remote monitoring technology during the COVID-19 crisis, launched the feature quickly.
“Knowing remote monitoring can help keep clinical trials on track during COVID-19, the Veeva team took this from an idea to live in six days,” she said.
“More specifically, it allows sites to work with monitors while onsite visits have largely stopped, helps sites continue running studies when they're unable to come into the office, and allows sponsors to access study data to maintain oversight and continue running studies when they're not able to come onsite,” she added.
