Evolving regulatory and patient safety mandates, like the recent updates to ICH GCP regulations, have a far-reaching impact on clinical trial management. Even the biggest players in the industry are far from the end goal of successfully meeting the required ICH standard. Regulators expect a risk based quality management of clinical trials with quality by design, effective oversight, increased transparency and reduced source data verification.

Navitas Life Sciences Is Here to Help

ICH E6 GCP addendum health check

We compile and review all relevant SOPs, templates, work instructions and associated documents, conduct thorough stakeholder interviews to intimately understand your internal processes, with the ability to conduct a majority of these activities off-site. Our services include, but are not limited to:

  • Detailed description of gaps between operational procedures and current legislation
  • Heatmap of functions in which the gaps reside
  • Provision of a clear roadmap for change to become compliant, with prioritisation of risks and mitigation strategies
  • Vendor assessment if required
  • Feedback to senior management team on strategy for success

delivering proven results that:

  • Enable effective and efficient compliance with improved visibility and control of risks
  • Provide clear and credible roadmap for internal and external communication
  • Enable efficient use of scarce resources to focus prioritised and systemic risks
  • Facilitate continuous improvement

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