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A DSMB monitors the safety of study participants and the effectiveness of the study investigational therapy during a clinical trial. Members of the disease community are often a member of a DSMB for a clinical trial for their disorder.
This regulation is intended to ensure that financial interests and arrangements of clinical investigators that could affect reliability of data submitted to FDA in support of product marketing are identified and disclosed by the sponsor of any drug, biological product, or device marketing application.
Janice Chang is the Chief Executive Officer at TransCelerate BioPharma Inc. Janice has been involved with the organization since its inception. In her current position, Janice works closely with the Board of Directors to shape the long-term strategic vision and priorities for the organization and its 30+ initiatives.
TransCelerate BioPharmas mission is to collaborate across the global biopharmaceutical research and development community to identify, prioritize, design, and facilitate the implementation of solutions designed to drive the efficient, effective and high-quality delivery of new medicines.
TransCelerates methodology shifts away from dependence on an On-site monitor to instead primarily enact monitoring duties through an emphasis on Centralized monitoring and/or Off-site activities.
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TransCelerate BioPharma is a non-profit catalyst for change in clinical research. We unite diverse voices across biopharmaceutical RD to drive innovation, simplify clinical trials and help bring new treatments to patients faster, safer and more efficiently.

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