Novella Clinical’s global Safety Management expertise allows us to tailor support to each customer’s needs, as well as perform Unexpected Adverse Device Effect (UADE) and Serious Adverse Event (SAE) collection and processing on pilot, pivotal, registry and outcome studies of various sizes.

Our highly skilled safety management team uses the latest validated electronic safety processes and workflow, eliminating the time and expense of maintaining paper case files, reducing processing time and lowering the risk associated with storing documents across multiple locations. We centrally receive and process important safety information 24/7 utilizing Oracle® Argus Safety 7.0.3, which enables regulatory compliance and drives product stewardship.

With aligned safety and clinical databases, we can customize parameters and data points during study start-up to compare patient safety profile listings throughout the life of the study. This reduces reconciliation time, which is particularly beneficial on large, high-volume studies.

Whether offered as a standalone service or part of a full-service contract our Safety Management services include:

 

  • Consulting and management planning
  • Protocol safety section development
  • Investigator/site training
  • Medical safety review
  • Review of UADEs and SAEs
  • Data transfers and legacy database integration
  • Remote data entry
  • Reconciliation
  • Safety narratives
  • Regulatory dictionary coding, report preparation, submission and distribution
  • Interim safety listings and reports
  • Preparation of listings for annual and periodic IDE reports