DMC Services

Data Monitoring Committee (DMC)

Independent DMC oversight supported by a 1500+ member network of experts

Advarra DMC services provide experienced, independent management and the expertise to oversee any therapeutic area.

Unmatched Expertise in DMC Oversight for 20+ Years

Advarra has the resources and expertise to assemble, charter, and manage your DMC within any therapeutic area, anywhere around the globe. Our goal is to facilitate the safety of trial participants, ensure the security of patient data, and maintain the integrity of clinical trial results, while working closely with your clinical trial team to adhere to country-specific regulations.

Timelines That Meet Trial Needs

From drafting the charter to contracting experts, Advarra DMC services have the fastest average time to kickoff in the industry so it won’t delay the start of your clinical trial.

Execution, Excellence, and Customer Satisfaction

By taking a proactive approach to communication, we address concerns early on and avoid surprises to minimize the chances of delays.

Global Regulatory Compliance

Project Managers stay current on US FDA and EU EMA guidelines, as well as any applicable country-specific requirements, which help ensure objectivity and independence in all aspects of DMC oversight.

Technology to Streamline Administration and Reporting

Advarra’s Safety Oversight Administration and Reporting (SOAR) Platform securely stores trial data, confidential DMC documents, and reports for your project.

The Advarra Difference

Committee Setup and Charter Development

Staffing: Our team will search for, qualify, and contract potential independent experts with sponsor input.
Expertise: Advarra’s global network of 1,500+ experts across all therapeutic areas allow Advarra DMCs to build committees for studies within any clinical specialty.
Regulatory Adherence: Your project manager will work collaboratively with your clinical team to develop a charter that meets the needs of your study and adheres to all applicable regulatory guidelines, such as US FDA and EU EMA.
Efficiency: Advarra achieves the industry’s fastest average time from project engagement to DMC formation thanks to our extensive expert network, so there won’t be any delays to the start of your clinical trial.

DMC Meetings and Ongoing Committee Management

Collaborative Project Management: Your dedicated project manager acts as a single point of contact to streamline communication and provide ongoing support throughout the duration of the trial. We strive to meet or exceed project communication and timeline expectations
Meeting Facilitation: Your project manager will schedule meetings, take minutes, generate reports, get signatures, and send results to sponsors.
One-Day Recommendation Turnaround: Sponsors receive DMC recommendations within one business day following a data review meeting.

Safety, Security, Integrity

Secure Data Exchange Management: Advarra’s Safety Oversight Administration and Reporting (SOAR) Platform is configurable and flexible enough to accommodate the needs of any type of clinical trial. Appropriate data access is given based on user-roles. All decisions and meeting outputs are tracked and auditable at all times.
_{The SOAR platform is compliant with all applicable regulations, including HIPAA, GDPR, PIPEDA, and FDA Part 11.}
Unbiased and Independent: As a third-party facilitator, Advarra ensures that committee members, committee proceedings, and committee results are unbiased and independent from the sponsor and CRO.

The Advarra Difference

Committee Setup and Charter Development

Staffing: Our team will search for, qualify, and contract potential independent experts with sponsor input.
Expertise: Advarra’s global network of 1,500+ experts across all therapeutic areas allow Advarra DMCs to build committees for studies within any clinical specialty.
Regulatory Adherence: Your project manager will work collaboratively with your clinical team to develop a charter that meets the needs of your study and adheres to all applicable regulatory guidelines, such as US FDA and EU EMA.
Efficiency: Advarra achieves the industry’s fastest average time from project engagement to DMC formation thanks to our extensive expert network, so there won’t be any delays to the start of your clinical trial.

DMC Meetings and Ongoing Committee Management

Collaborative Project Management: Your dedicated project manager acts as a single point of contact to streamline communication and provide ongoing support throughout the duration of the trial. We strive to meet or exceed project communication and timeline expectations
Meeting Facilitation: Your project manager will schedule meetings, take minutes, generate reports, get signatures, and send results to sponsors.
One-Day Recommendation Turnaround: Sponsors receive DMC recommendations within one business day following a data review meeting.

Safety, Security, Integrity

Secure Data Exchange Management: Advarra’s Safety Oversight Administration and Reporting (SOAR) Platform is configurable and flexible enough to accommodate the needs of any type of clinical trial. Appropriate data access is given based on user-roles. All decisions and meeting outputs are tracked and auditable at all times.
_{The SOAR platform is compliant with all applicable regulations, including HIPAA, GDPR, PIPEDA, and FDA Part 11.}
Unbiased and Independent: As a third-party facilitator, Advarra ensures that committee members, committee proceedings, and committee results are unbiased and independent from the sponsor and CRO.

Manager Spotlight

Barbara Schneider, PhD, MBA

Executive Director, DMC/EAC Services

Dr. Barbara Schneider heads Advarra’s independent services for DMCs and endpoint adjudication committees (EACs), which have provided trusted safety oversight for clinical trials since 2002. Prior to joining Advarra, Dr. Schneider was the founder and CEO of Watermark Research Partners. Watermark was one of the first companies to provide independent data safety monitoring board (DSMB) services and endpoint adjudication to the clinical trial industry. (Watermark joined Advarra in 2021.)

James Riddle, MCSE, CIP, CPIA, CRQM

Senior Vice President, Global Review Operations

James Riddle brings 25+ years of experience providing support to the clinical research community and oversees all of Advarra’s global review services including IRB, IBC, DMC, EAC. In this role, he helps sponsors, CROs, and research sites advance clinical research with a mission to improve human health. His expertise includes developing and operationalizing processes for maximum efficiency, client satisfaction, and participant protection; development and implementation of technology solutions; and efficient, compliant operation of large clinical research review programs. Riddle is a regular speaker at industry events and has written abundantly on research compliance and efficiency topics. He is also a member of CTTI, NWABR, SASI, and PRIM&R.

Tina Tran

Strategic Services Provider, DMC/EAC

Tina Tran comes with a wealth of knowledge in all things Data including study design, statistical methodology, biostatistics, data management, eCRF design/specs, electronic data capture (EDC), EACs, and DMCs. Tran brings her prior experience from the University of Washington, Axio Research, Cytel Statistics and Data Corporation (SDC), and Unlearn AI. Tran received her Bachelor of Science from the University of Washington.

Featured Content

Info Sheet

Data Monitoring Committee (DMC) Services Info Sheet

Advarra’s biostatistical and medical experts offer customized DMC solutions, aligning oversight with the specific needs of your clinical trial.

Blog

The Importance of Keeping DSMBs Independent

Establishing DSMB independence helps mitigate bias, ensuring clinical trials adhere to regulatory standards and build public trust.

Blog

Understanding FDA’s 2024 Draft Guidance on DMCs

The FDA’s 2024 draft guidance emphasizes the critical role of independent DMCs in clinical trials, enhancing oversight, safety, and trial integrity.

Blog

DMC vs EAC: What’s the Difference?

Clinical research oversight relies on both DMCs for big-picture data review and EACs for detailed event assessments. Learn how each committee enhances trial safety.

Frequently Asked Questions

Explore our comprehensive FAQ page for detailed answers to questions about our IRB, IBC, DMC, and EAC services.

Find Your Answers