Safety Letters

A Better Way to Communicate with Sites Worldwide

Distributing safety notifications and tracking acknowledgements with sites around the world is a prime example of an important but cumbersome manual process that can be made simple and efficient using technology. While sending safety letters seems easy on the surface, numerous layers of complexity (e.g. distribution lists, country exceptions, translations, site activation status) make it a labour-intensive task that requires a lot time, money and attention that is better spent elsewhere.

Powered by the robust Workflow engine and secure Document Exchange on DrugDev Sparkā„¢, our Safety Letters solution eliminates the challenges of managing notifications for a single study or across an entire trial portfolio by…

  • Streamlining the distribution process with sites and ethics boards
  • Tracking all activity history in a comprehensive audit trail
  • Automatically calculating due dates based on configurable Workflow rules
  • Enabling full-text searches for investigators seeking information that may inform patient care
  • Ensuring sites download letters before allowing acknowledgements 
  • Creating a tracking process to ensure compliance
  • Integrating with CTMS and safety systems

DrugDev Safety Letters delivers a clear ROI by automating manual processes to eliminate FedEx and courier charges, process outsourcing, and excessive internal costs dedicated to accomplishing a task easily handled by automation. By enabling efficient notification distribution and acknowledgement tracking across multiple studies, DrugDev technology enables sponsors and CROs to reduce costs, free internal resources and, most importantly, alleviate site burden to remove hurdles during activation, recruitment and patient monitoring.