Site Monitoring Services
WEP’s monitoring group provides comprehensive site monitoring and quality control services to ensure your clinical trials meet regulatory standards, maintain data accuracy, and prioritize patient safety. Our expert field based and remote Clinical Research Associates (CRAs) teams work proactively to mitigate risks, ensure protocol adherence, and uphold GCP (Good Clinical Practice) standards.
WEP On-Site & Remote Monitoring
- We have a global field based CRA team to provide regular onsite visits.
- Risk-based monitoring (RBM) to optimize resources while maintaining quality oversight.
- Remote monitoring capabilities to allow a more balanced and cost-effective solution when needed.
Key Responsibilities of the WEP Clinical Monitoring Team Include the Following:
Site Selection & Initiation
- Assess potential investigational sites for feasibility
- Train site staff on protocol, GCP, and regulatory requirements
Patient Enrollment & Informed Consent
- Verify that patients meet eligibility criteria
- Ensure informed consent is obtained properly
Source Data Verification (SDV) & Quality Control
- Check that data in Case Report Forms (CRFs) match source documents
- Identify and resolves data discrepancies
Protocol Adherence & Compliance
- Ensure investigators follow study procedures and regulatory guidelines
- Detect and addresses protocol deviations or violations
Investigational Product (IP) Management
- Ensure proper storage, dispensing, and accountability of the study drug
- Verify compliance with dosing and administration instructions
Adverse Event (AE) & Serious Adverse Event (SAE) Reporting
- Confirm that adverse events are reported accurately and timely
- Ensure sites follow safety reporting procedures
Site Visits & Monitoring Reports
- Conduct on-site or remote monitoring visits to assess compliance
- Document findings in monitoring reports and follows up on corrective actions
Closeout & Archiving
- Ensure proper completion of study records
- Verify data integrity before site closure