Safety and Pharmacovigilence

The USDM Life Sciences Clinical Practice offers Safety and Pharmacovigilance support across all phases of the development lifecycle. We create efficient drug safety processes and support the development lifecycle by authoring clear documentation for our clients.

Our Clinical Practice is known for establishing compliant clinical systems and extends that expertise and proven processes into the Safety realm. We install, up-version and/or migrate our Safety Reporting and Databases for our clients and offer continual system maintenances services to ensure the very best possible performance and compliance.

Reconciliation between Clinical and Safety databases must be done to ensure accuracy in collecting and reporting safety information to regulatory authorities. Our Clinical Practice team members have years of experience in the reconciliation process and understand the collaborative efforts necessary to complete this mandated component of the overall process.

Safety and Pharmacovigilence Services:

  • Protocol Review
  • SAE Reporting and Reconciliation
  • Safety Database specification, development, change control management and user acceptance testing (Argus, ARISg)
  • SOP Development

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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