Data monitoring committees (DMCs) review the safety and pharmacovigilance data of clinical trials and are a crucial piece of the overall product development process. Westat’s expert biostatisticians – members of our Design and Analysis (DA) Unit – draw on more than 20 years of experience to establish and manage all aspects of a DMC and associated meetings. From selecting subject matter experts (SMEs) to distributing meeting minutes and all steps in between, our reliable team delivers end-to-end DMC support.

Independence and Objectivity

Maintaining independence from clinical trial sponsors enables Westat’s statistical team to perform crucial functions, including:

• Developing DMC charters and mock outputs
• Frequent communication between sponsors and DMC members
• Providing unmasked outputs for objective reviews of your study’s safety information
• Continuous review and oversight of project-specific documentation and procedures

Access to Leading Experts

With vast experience working with DMCs, Westat has developed a directory of SMEs across a range of therapeutic areas. This enables us to select the most appropriate DMC members for your review committee.

Focusing on the Details

Once your DMC is established, our team can provide coordination for DMC meetings, prepare and distribute meeting materials, and record and distribute open and closed session meeting minutes – all necessary details that are critical for successful meetings. We will also ensure that your DMC has a dedicated senior biostatistician to lead a team providing independent support for DMC services, including generation of masked tables, figures, and listings for sponsor review, as well as corresponding unmasked outputs for DMC review.

Related Team Members