Data Safety Monitoring Board (DSMB)

IRBco offers experienced, efficient, and truly independent DSMB services for the broad range of clinical trials, from small Phase I projects to large, international Phase III trials and Phase IV studies. The independent DSMB members have chaired and participated in scores of clinical trial DSMBs across multiple disease specialties. Our DSMB members have expertise in specific diseases, in ethics, patient advocacy, and in biostatistics

Experienced, independent Data and Safety Monitoring Boards (DSMBs) are crucial for optimal ethical and scientific conduct of individual clinical trials and for the perceived integrity of clinical research enterprise as a whole by the public and regulatory agencies. DSMBs are an important, often under-appreciated, component of clinical trials with wide-ranging responsibilities to trial participants, investigators, trial sponsors, local human subject committees, and national regulatory agencies. To fulfill these obligations, DSMB activities must be carried-out by those with DSMB experience and with complete independence from the trial investigators and the sponsor. Yet, in most cases, the DSMB members are chosen by the trial sponsor, and organization of the DSMB is often delegated to those with little experience, almost as an afterthought to trial initiation.

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IRBco is awarded Full Accreditation by the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP). Accreditation validates our comprehensive program which integrates ethical reviews, state-of-the-art technology and staff development to create an environment of responsible and ethical human subject protection. We provide our services at levels beyond client expectations and that exceed federal requirements for safeguarding participants. We believe that accreditation leads to an increased level of professional accountability.

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