Data Monitoring Committee (DMC) Services

Each research trial is different, with unique data safety monitoring plans, endpoints, and statistical designs. Advarra’s global network of biostatistical and medical experts will collaborate with you to design and manage DMCs, or data safety monitoring boards (DSMBs), ensuring expert oversight and compliance with regulatory guidelines.

Key Features

Independent oversight of interim clinical trial data
Compliance with U.S. FDA and EU EMEA guidelines
Over 1,500 global statisticians and medical professionals
More than 20 years experience administering DMCs worldwide
Committee meeting recommendations within one business day

Comprehensive Independent Trial Oversight

Charter Development

Collaborate with Advarra’s expert statisticians and DMC administrators to develop a detailed charter aligning with Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. This ensures your DMC’s foundation is strong with input from both sponsor or contract research organization (CRO) teams, and with Advarra’s specialists.

Enhanced Data Security and Regulatory Compliance

Your trial’s critical data is protected by Advarra’s state-of-the-art data protection technologies, ensuring compliance with global privacy regulations such as Health Insurance Portability and Accountability Act (HIPAA), General Data Protection Regulation (GDPR), Personal Information Protection and Electronic Documents Act (PIPEDA), and FDA Part 11.

Independent Statistical Support

Advarra’s DMC Statistical Center offers in-depth support, including the development of statistical analysis plans (SAPs); SAS programming; tables, listings, and graphs (TLG) creation; and validation according to 21 CFR Part 11 standards. Advarra’s team can serve as unblinded statisticians and prepare periodic statistical reports for DMCs, regardless of the administering organization.

Independent and Integrated Oversight Process

While the DMC reviews interim clinical trial data independently from Advarra’s other review committees, an integrated and experienced services team oversees the overall process. Reviews are coordinated to avoid delays throughout the trial. Your dedicated point of contact will provide an unmatched level of knowledgeable, responsive support tailored to your priorities.