Our team of experts are ready to provide unrivalled case management quality, using diverse hosting options.

Our PV experts carry out the collection, data entry, MedDRA coding, narrative writing, medical assessment and expedited reporting of individual case safety reports (ICSRs). PrimeVigilance provides a wide-ranging suite of case processing options with or without medical review, for both clinical trial and post-marketing cases.

With caseloads inflating by 30–50% annually and regulations undergoing continuous change, efficient case management and maintaining compliance are vital in our business.

  • Our flexible case management enables business continuity and ensures regulatory compliance and patient safety.
  • We offer an unrivaled case management quality and process over 350,000 initial and follow-up versions each year with a >99% on-time completion compliance rate. 97% of clinical cases completed within 5 follow-up attempts and 89% are closed within 3 follow-up attempts.
  • PrimeVigilance’s EDC Capabilities/SAE Management System has reduced burdens for clinical investigators by overcoming differences in case intake (e.g., paper, EDC, gateway) due to the nature and geographic distribution of clinical studies or programs, vast complexity of data and demanding source data verification.

Quick Facts


ICSRs processed p.a.


on-time completion compliance rate


clinical cases completed within 5 follow-up attempts