Medical Monitoring Support
Medical monitoring is critical for the success of clinical trials, ensuring ethical conduct, regulatory compliance, and ultimately, safe and effective treatment development. WEP’s Medical Monitoring team works closely with the PV and Quality teams to protect patient health and rights, ensure trial integrity and validity, and helps detect early safety signals that could impact the drug’s approval.
Our medical monitors provide continuous oversight of your study to ensure participant safety, protocol adherence, and data integrity.
Key Responsibilities of WEP's Medical Monitoring Team Include:
Patient Safety & Risk Management:
- Ensure participant well-being by identifying and mitigating potential safety risks.
- Review serious adverse events (SAEs) and adverse events (AEs).
- Assess benefit-risk balance throughout the trial.
Protocol Adherence & Compliance:
- Ensure the trial follows Good Clinical Practice (GCP) and regulatory guidelines.
- Support investigators in implementing the protocol correctly.
- Address deviations and violations.
Medical Query Resolution:
- Provide guidance on eligibility criteria, dosing, and medical assessments.
- Respond to investigator questions about participant care.
Data Review & Interpretation:
- Monitor safety data, efficacy signals, and trends in patient responses.
- Review laboratory values, vital signs, and imaging data.
- Participate in Data Safety Monitoring Board (DSMB) meetings.
Regulatory & Ethics Compliance:
- Ensure proper reporting of adverse events to regulatory authorities.
- Provide medical input on regulatory documents (e.g., Investigator’s Brochure, Clinical Study Reports).