Regulatory Affairs
Comprehensive listing of services
Regulatory consulting & submissions
Pharmacovigilance
Adverse event information
Auditing
Electronic Submissions
what we do : regulatory affairs : pharmacovigilance : adverse event information

Adverse event information - case histories

  • Between January and July 2004 in the US we managed 47 ongoing or complete clinical trials involving 202 initial serious adverse events/adverse events and follow-up on 331 cases
  • In Europe for 2004, we managed 10 studies involving 2,274 serious adverse event cases and 1,949 follow-up cases
  • During one pharmacovigilance project, we reviewed 1,756,796 records that included 17,902 serious adverse events, adverse events and suspected events requiring follow-up
  • For another pharmacovigilance project, we reviewed 27,091 records and processed 10,117 cases
  • In the first eight months of 2004, for one product alone we processed 3,412 adverse events
  • We developed an electronic case triage and follow-up system, which saved our client $3.8 million in human effort time and $0.55 million in mailing costs