Data Safety Monitoring Board
Support for Medical Monitoring
At Gemini Group, our Data Safety Monitoring Board (DSMB) services provide you with enhanced workflows, compliance, and communication to ensure the safety and reliability of your clinical study data.
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Our team of consultants provides the option of safety data review (i.e., individual case safety reports and/or aggregate summaries of data) by a licensed physician with experience in pharmacovigilance. The review and consultation include an assessment of the data and its consequence to the management of the study. Our team then provides advice for any actions to be taken, including reporting of aggregate data to the FDA as an IND Safety Report, requesting review by the Data Safety Monitoring Board, and/or changes to the Investigator Brochure, Informed Consent Form, or study protocol.
Subject Matter Expertise for Your Clinical Study Needs
Gemini Group’s DSMB, medical monitoring, and physician teams support a wide range of therapeutic areas and will meet your specific needs. We will make sure that your study continues moving forward in the most professional and precise manner by providing any or all of the following services:
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Reporting a serious adverse event (SAE)
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Protocol analysis and review for exemptions and deviations
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Medical crisis impact analysis and review involving a study patient
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Laboratory analysis and findings review
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Blinded and un-blinded DSMB meeting support
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Biostatistician analysis and review
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DSMB program support
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Eligibility requirements analysis and review for inclusion/exclusion criteria issues
Contact
Get in touch to learn more.