Data and Safety Monitoring Board (DSMB)
A Data Monitoring Committee (DMC) is an autonomous collection of clinical professionals which monitors patient safety andefficacy data. A DMC; also known as Data and Safety Monitoring Board (DSMB), affords a compliant and self-governing review of clinical data in light of the Benefit: Risk ration.
GAP has provided DMCs that have included proper known opinion leaders and experts. Our established DSMBs have provided their expertise in an efficient and effective fashion with delivering their timely analyses and results.
Our expert panels have provided:
- Expertise when a study endpoint results a highly favorable or unfavorable outcome. Additionally, finding of futility, during its interim analysis lead to termination of the study before its planned completion.
- Signals translating into clinical reasons and lead into safety signals. Some signals were mitigated with amending the protocol, and/or its label including but not limited to dose regiment modification, labeling informational recommendation as well as treatment management algorithms.
- Proper clinical knowledge of known prior safety signal in suggesting the possibility of serious adverse events including known clinical and pharmacological toxicity in the study treatment population. Effective epidemiological and algorithmic analysis is critical.
- Population and sub- population analysis in the treatment profile of the study drug.
GAP will establish the standard operating procedure (SOP), provide the structural foundation, and operate the SAC internally or externally as needed.
GAP has the knowledge, hands on experience, and proven track record in establishment and operations of SACs with effective as well as cost- containment measures in place.
Current clients include Top BioPharmas as well as a TOP Device company in the US.
Contact us for more information.