Country and Site Regulatory Intelligence
With more than 30 built-in country packages that match regulatory requirements globally, study start-up teams can easily and confidently navigate complex and frequently changing country regulations required to gain ethics and regulatory approval. When regulations change, Veeva Vault Study Startup will change ensuring that best practices are always up to date.
Single Source of Truth with eTMF
By providing a seamless connection to Veeva Vault eTMF, there is one source of truth for shared TMF and start-up content and data. All users access the same document version. Team members use Veeva Vault Study Startup to collaborate with each other directly within the Veeva Vault Clinical Suite, increasing communication across team members and overall clinical development efficiency.
Because study start-up documentation and associated data (including milestone information, baseline, projected and actual dates) is managed with a single system, sponsors and CROs have early visibility into bottlenecks associated with document-related activities and study events. As a result, start-up resources can be more efficiently allocated and adjusted based on start-up progress.
Beyond study start-up specific reports and dashboards, start-up specialists and managers have a dedicated landing page designed to provide a clear and complete snapshot of start-up progress, including greenlight approval and at risk activities. All major start-up milestones, bottlenecks, and progress toward completion is displayed and team members can drill down into underlying activities.