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Our DSMB and team support a wide variety of therapeutic areas keep your study moving forward by providing the following services:
- DSMB program support
- Blinded and unblinded DSMB meeting support
- Eligibility requirements review for inclusion/exclusion criteria issues
- Protocol review for exemptions and deviations
- Medical crisis impact review involving a study patient
- Biostatistician review
- Laboratory findings review
- Reporting a serious adverse event (SAE)
- Causality assessment discussions