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Life Sciences

Aggregate Report Preparation In Safety And Pharmacovigilance

Aggregate report preparation represents one of the single most time- and resource-intensive pharmacovigilance regulatory requirements, which is why many companies are interested in more automated solutions that are fit-for-purpose.

What we typically recommend to clients is a focused approach that optimizes as much as their internal workflow as possible. We also recommend that subject matter experts, who have deep knowledge of the technical, regulatory and pharmacology implications, evaluate the client’s current practices and pain points.

Part of such an evaluation could be understanding the types and cadence of aggregate reports, DLPs, case volume, current regulatory status, and complexity based on the particular asset. Once that information is available, a workflow and technology platform solution to minimize common aggregate report (AR) pain points, could be made.

Potential aggregate reporting enhancements to streamline business practices may include:

  • Harmonizing and automating AR project plans in advance of the DLP
  • Generating automated RACI for each type of report (e.g., DSUR, PBRER) and populating contributors with auto notifications on their calendars
  • A template repository for each type of report; requiring AR updates only where necessary
  • Configuring automated data pulls from Oracle Argus Safety (or another system) to cut and paste into the AR template so a draft document is readily available
  • Document review cycle optimization
  • Automated data “clean up” and extraction to minimize manual error-prone extractions
  • Automated workflow notifications to contributors to maintain AR projects on required timeline

If you are interested in learning more about how we can help improve your aggregate reporting activities, feel free to reach out.

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Kari Blaho-Owens

Kari Blaho-Owens, Ph.D., received her graduate degree in pharmacology and clinical therapeutics from LSU Medical Center in New Orleans, Louisiana, US. She was the Research Director and clinical toxicologist consultant in an inner-city Emergency Department at UT College of Medicine and has spent much of her career in the life sciences industry working for pharmaceutical and device companies, as well as CROs. She also served as the global head of PV at a major company. Kari is currently the head of PV at Perficient, where she leads a team that implements fit-for-purpose technology solutions and provides pharmacovigilance consulting. She is also a peer reviewer for the DIA.

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