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Monitoring safety for clinical studies is of paramount important. Our medical staff consists of board-certified physicians who are available to provide medical consultation as well as medical oversight of clinical studies. Our core therapeutic expertise is in the area of oncology; however, we have board-certified physicians in other therapeutic areas as well.
Our medical monitoring services include the following:
- Study design, protocol review and development, abstract/manuscript review
- Review and assessment of serious adverse advents (SAEs)
- Investigator recruitment
- Medical narratives for SAEs
- Medical safety monitoring of study (CRF review)
- MedDRA coding
- Drug Safety Monitoring Boards (DSMBs)
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