Veeva Systems, a provider of Cloud-based software for the life sciences industry, has announced the launch of Veeva SiteVault Free, a free eRegulatory solution for clinical research sites.
Clinical research sites can use the solution to manage regulatory documents and trial processes to streamline trial activities and accelerate clinical research.
The US-based company claimed that Veeva SiteVault reduces the administrative burden of managing regulatory documents and processes as it offers several capabilities, including electronic signatures, remote monitoring, certified copy workflows, as well as reporting.
The eRegulatory solution can be used for all trials irrespective of the technology used by sponsors, as well as the site file for investigator-initiated trials.
The company’s two variants, SiteVault Free and SiteVault Enterprise, comply with 21 CFR Part 11 and HIPAA requirements.
SiteVault Enterprise is a configurable edition of Veeva SiteVault and includes open APIs for integrations, customised reports, and tailored workflows.
SiteVault Enterprise is being used by several research organisations, including IACT Health, Ora, Penn Medicine, and the University of Louisville.
SiteVault Free is expected to be launched in December 2019 and can be used by an unlimited number of users, with Veeva offering full customer support.
Veeva founder and CEO Peter Gassner said: “Veeva aims to simplify study execution so sites can focus on the critical work of clinical research and patient care.
“We’re proud to partner with the clinical research community to help simplify and accelerate the process of getting important medicines to the patients who need them.”
The company provides clinical operations technology with more than 200 sponsors using Vault eTMF or Vault Study Startup.
It intends to allow automated document and data sharing from sites using Veeva SiteVault to sponsors using Vault eTMF or Vault Study Startup in the second half of 2020.
The company caters to over 775 customers, ranging from large pharmaceutical companies to emerging biotechs. It has offices in North America, Europe, Asia, and Latin America.