Pre-Trial Site Visits & Compliance Checks
Pre-Trial Site Visits & Compliance Checks
If agreed to by the Sponsor, WEP will manage pre-trial site visits and compliance checks to ensure that investigative sites are qualified, prepared, and compliant before the clinical trial begins. These pre-trial activities are essential to minimize risks, ensure protocol adherence, and set the stage for a successful study.
Key Services at WEP Include the Following:
Site Initiation Visit (SIV)
Before enrolling patients, WEP conducts a Site Initiation Visit (SIV) to confirm:
- All required approvals and contracts are in place.
- Study materials (investigator brochures, protocols, case report forms) are provided.
- Trial equipment (centrifuges, ECG machines, lab kits) is properly set up and validated.
- Site staff is fully trained and certified for study execution.
- Investigational product (IP) management is in place (storage, handling, accountability).
- Patient recruitment strategies are aligned with sponsor expectations.
Ongoing Compliance Monitoring
After a site is activated, WEP ensures ongoing compliance through:
- Regular site monitoring visits to review trial conduct, protocol adherence, and patient safety.
- Remote monitoring for real-time data review and site engagement.
- Risk-based monitoring (RBM) strategies to identify potential compliance risks early.
- Corrective and preventive actions (CAPA) for any compliance deviations.
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