Ensuring compliance with rapid, accurate reporting

We are responsible for the submission of EU regulatory case reports for a global clinical trial, with a co-running trial using the same Investigational Medicinal Product (IMP), managed by another sponsor.

In 2015, we received an extremely late case report from our client’s Pharmacovigilance (PV) team. Prior to this compliance and reporting had worked well. We reacted quickly and diligently to ensure our client achieved compliance.

Challenges

  • Report received on day 14 of a 15-day submission timeframe.
  • The sponsor causality statement was missing.
  • The report included over 600 laboratory tests, all requiring coding in EudraVigilance (EVWEB) and a
    submission Quality Check (QC).
  • A client based in a different time zone.

Our approach

  • Collaborative – Our Case Management Team and PV Project Manager collaborated to achieve an extremely fast turnaround.
  • Flexible – We worked out-of-hours to communicate directly with our client to highlight issues and resolve queries promptly.
  • Proactive – Our PV Project Manager worked closely with our client to develop a Corrective and Preventative Action (CAPA) that addressed the cause of the late submission.

Outcomes

  • A complete case report was submitted to all regulatory authorities, ethics committees and investigators in the required 15-day timeframe.
  • Acknowledgement of the EVWEB submission was received and our client achieved compliance.
  • Working closely with our client, we have implemented a new process to ensure future case reports are received earlier.

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