Data Monitoring Committee Services
Ensuring patient safety and trial integrity
As the clinical research landscape becomes increasingly complex and digitally driven, regulatory scrutiny is intensifying, making high-quality study data and patient safety more critical than ever. The success of a trial hinges on the integrity of its data.
As a result, Data Monitoring Committees (DMCs) have become increasingly significant in clinical trial oversight, with a growing emphasis on proactive safety surveillance and data review.
More than ever regulators are recognising the need for the DMC to be completely independent from the sponsor. To achieve true independence, trial integrity and independence from internal and external study teams, many sponsors are now deploying a single solution provider.
Experience & expertise
For almost 20 years, ICON’s Data Monitoring Committee (DMC) team has had a dedicated DMC department committed to ensuring the highest standards of safety and integrity in clinical research. Our expert services provide independent oversight, ensuring the reliability of your clinical trial while prioritising patient safety.
Our global team of experts has the capabilities to meet the most stringent regulatory requirements. We have supported the planning, management, and data delivery of DMCs for over 1,000 projects, spanning all phases of device and drug development across multiple therapeutic areas, including paediatric populations and adaptive trial designs.
ICON's DMC experience covers:
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Our DMC services are characterised by:
Independent expertise
Our DMCs are comprised of industry-recognised healthcare professionals and statisticians who provide objective insights and recommendations based not only on study results but their clinical expertise to ensure patient safety.
Tailored solutions
We offer flexible options to meet your specific project needs, as a standalone service, part of a full-service project or collaborating with other vendors. In addition, we support both independent and non-independent committees such as internal review committees (IRCs), safety review committees (SRCs) and dose escalation committees (DECs).
Dedicated project management
Each DMC project is overseen by a highly qualified project manager who serves as the primary liaison between the study team, sponsor, and DMC, ensuring seamless execution while limiting sponsor to DMC communication.
Robust processes & regulatory compliance
Our standard operating procedures are aligned with EMA and FDA guidelines, streamlining workflows while upholding the scientific validity and integrity of study results.
Global network
Our extensive DMC experience allows us to recruit the right experts tailored to your study's requirements.
Independent data review
Our DMCs regularly review study data to identify potential risks ensuring participant safety through timely recommendation as well as review for futility and efficacy.
Adaptive trial support
We provide support on necessary modifications to trial designs, including sample size adjustments and treatment arm changes.
Flexible options to suit your study
Our comprehensive services can be customised to meet the unique needs of a project, offering the following options:
- Member identification, vetting, and contracting
- DMC charter development
- Organisational and DMC data review meeting planning including date/time selection, venue recommendation, arrangement of travel and accommodations
- Controlled, access-restricted firewall provision to safeguard data review packages to DMC members via global 24/7 accessible password-protected directories
- Full meeting documentation including agenda development, presentation compilation, meeting moderation, meeting minutes preparation and distribution of DMC recommendation
- Delivery of independently produced statistical outputs
- TMF maintenance
Exploring FDA guidance for modern Data Monitoring Committees
In this whitepaper, we explore the new FDA draft guidance on Data Monitoring Committees, highlighting key updates and their impact on DMC operations and clinical trials.