Improved Pharmacovigilance Agreement Process To Support Trial Start-Up

Featured Solution: Pharmacovigilance Agreements (PVAO) “Glossary.”

Our company has multiple instances of the use of TransCelerate’s Pharmacovigilance Agreements Optimization (PVAO) “Glossary.” Our company regards the Glossary as a trusted resource, especially because we are familiar with the effort, including the identification of regulatory sources, that went into the development of this key solution but also for its inherent benefits.  Three instances of use include:

• Creation of a new template: We created a brand-new template leveraging the Glossary dedicated to clinical trial supply agreements.  The new template is approved and went into production.
• Updating an existing template: The Glossary also triggered an internal discussion about the definitions we use in business partner licensing agreements and geared us to give attention to definitions that are not widely accepted by the industry.  We revised the template by mapping these definitions chosen from the Glossary to the existing terms.  The updated template will go into production soon.  This internal harmonization provides consistency across the process and reduces time spent aligning in the future.
• Resolving a potential impasse related to terminology:
  • We used the Glossary while negotiating a PVA with another company.  Each company had different definitions of what “invalid” and “incomplete” mean. As a result of this impasse, we could not close “corrective and preventive actions” (CAPAs) because of the differing interpretations our companies had of what constitutes an “invalid case” or “incomplete” case.
  • As a potential solution, we suggested consulting the Glossary to identify any potential common ground on terminology. Consequentially, both companies steered away from using the terms “invalid” and “incomplete” and instead agreed to adopt the term “minimum criterium for adverse event.”  This mutually agreed-upon use of this term and definition helped both parties mitigate their concerns and engage in a constructive discussion.  We completed the PVA based on the new definition.
  • The outcome was that the CAPA could be closed, and the alignment on terminology allowed both parties to move beyond a potential impasse.

In all three instances of use, we were able to reduce time spent aligning either internally or externally on definitions and redirect that time toward higher priority areas such as executing an agreement for clinical trials. This ultimately helps improve patient safety because it impacts our time spent drafting and negotiating, which helps improve the timeliness of our PVAs and reduces our risk of experiencing delays to key milestones (such as clinical trial start, access to treatment, etc.).     

[Sponsor Company]