Challenges • Manual processes were dominated by one central paper binder • Regulatory documentation was not in digital form or accessible in a central, searchable database • The site lacked the data management foundation needed for remote digital site monitoring • There were no features in place to allow reviewers and stakeholders to view and collaborate on regulatory documentation Results • More than 500 paper GCP documents were digitized and added to SiteVault Free within four months • Reviewers and study partners can now access, view, and collaborate on documents • The paper binder is now a secondary, rather than primary, source of regulatory documentation

Join for free to read