Protocol Amendments
The WEP team is well-equipped to support Sponsors with protocol amendments in response to interim findings, safety concerns, or regulatory feedback. By leveraging expertise in regulatory compliance, safety monitoring, and clinical trial management, we help Sponsors navigate protocol amendments efficiently and effectively. This ensures trials remain compliant, scientifically sound, and patient-focused while minimizing disruptions.
WEP will Support with the Following:
Regulatory Strategy & Compliance
Ensure that protocol amendments meet regulatory requirements by:
- Providing regulatory guidance on amendment submission strategies.
- Preparing and submitting revised protocol documents to health authorities (e.g., FDA, EMA, MHRA, PMDA).
- Managing communication with regulatory bodies to facilitate approvals.
- Ensuring compliance with Good Clinical Practice (GCP) and ICH guidelines.
Protocol Revision & Documentation
Assist in revising the protocol by:
- Working with medical writers and clinical experts to draft protocol amendments.
- Updating key study documents, including:
- Investigator Brochure (IB)
- Informed Consent Forms (ICF)
- Case Report Forms (CRF)
- Monitoring Plans
- Revising Statistical Analysis Plans (SAPs) based on new trial objectives.
Site & Investigator Communication
Ensure smooth implementation by:
- Notifying investigators and trial sites about protocol changes.
- Providing training for study teams on updated procedures.
- Ensuring sites understand revised eligibility criteria, dosing regimens, and safety monitoring guidelines.
- Updating electronic data capture (EDC) and clinical trial management systems (CTMS) to reflect changes.
Trial Re-Optimization & Risk Mitigation
Adjust operational aspects of the trial, such as:
- Adjusting recruitment strategies based on revised eligibility criteria.
- Revising data collection methods to align with new endpoints or safety monitoring procedures.
- Implementing adaptive trial designs to optimize efficiency.
Post-Amendment Monitoring & Compliance
Maintain compliance and oversight following protocol amendments:
- Ensure site compliance with the updated protocol.
- Conduct additional quality checks and monitoring visits.
- Provide ongoing support for regulatory inspections and audits.
- Track and report any new safety signals post-amendment.