Charter Support for Medical Monitoring
At ProPharma Group, our Data Safety Monitoring Board (DSMB) services provide you with improved workflows, compliance, and communication to ensure the safety and integrity of your clinical study data.
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 physician with experience in pharmacovigilance. The review and consultation include an assessment of the data and its significance to the conduct of the study. Our team then provides a recommendation 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.
Expertise for Your Clinical Study Needs
ProPharma Group’s DSMB, medical monitoring, and physician teams support a wide variety of therapeutic areas and will meet your requirements and keep your study moving forward by providing any or all of 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
- Clinical Trial Emergency Unblinding Services