Pharmacovigilance Systems

In strict terms, pharmacovigilance is the study of the adverse effects of a new drug, being tested. But the vigilance doesn't end at the clinical trial stage itself. It goes on, even once the drug is in the market and ensures that any adverse reaction, even if it is a minor one, is recorded, processed, understood and prevented.

Pharmacovigilance is important because despite the best efforts of the industry, each drug is tested only on a few thousand patients/subjects and while it does tell us a lot about the drug and its effects on the body, the variables in a clinical trial are controlled and results relate only to the trial group. Once out in the market, the drug is used by a larger group, often in combination with drugs for other diseases and treatment and maybe by people of varying age groups, all of which increases the potential risk base of the drugs.

Our team can help you effectively select, develop and validate your safety management system and ensure regulatory compliance, so you can be confident your company is protecting its patients, study participants and reputation. WE provide our clients in the Life Science Industry with hands-on consultants that are experts in the vendor selection, requirements definition, implementation and validation of Pharmacovigilance systems.

USDM has successfully completed projects for the following flagship Pharmacovigilance systems:

  • Oracle ARISg
  • Oracle AERS
  • Oracle ARGUS

Having successfully completed the qualification process with the FDA and EMEA, USDM also assists its partners with the Electronic Submission (E2B) process. Our experienced teams have worked with our Clinical/CRO partners in the requirements, implementation, configuration and validation of Microsoft's BizTalk Server and Axway's Synchrony eSubmissions B2B Gateway systems, enabling them to send data from their Pharmacovigilance systems to other companies electronically (E2B).

As a critical part of assisting you in achieving regulatory compliance, USDM consultants facilitate the analysis of your company's current business processes and how they relate to the strategic direction of your safety system needs. Utilizing a proven methodology, the USDM team will evaluate your existing business processes and procedures against present regulatory requirements. Your system would then be configured to meet or exceed the requirements of your regulatory environment.

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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