Data Monitoring Committee – DMC
Comprehensive Data Monitoring Committee Services
EXPERTS IN ADAPTIVE DESIGNS – SPECIALISTS IN BAYESIAN BIOSTATISTICS METHODS
A DMC – Data Monitoring committee or IDMC – Independent Data Monitoring Committee or DSMB – Data Safety Monitoring Board, is an independent panel of experts who periodically review clinical trial data to ensure integrity, scientific rigor and patient safety in clinical studies. Ensuring patient safety and clinical trial integrity through the independent evaluation of interim clinical trial data is of critical importance for increasingly complex drug development programs. Data Monitoring Committees (DMCs) are an essential component of many clinical trials. To support this critical function, IDDI provides comprehensive Data Monitoring Committee services.
A unique combination of experience and expertise positions IDDI as a premier provider of data monitoring committee services. Since its inception, IDDI has supported numerous pharmaceutical companies and biotech companies in the planning and management of more than 200 Data Monitoring Committees in all major therapeutic areas in compliance with relevant regulatory guidelines (FDA and ICH).
Data Monitoring Committee (DMC) Services:
- DMC member recruitment
- Contract management of the DMC members
- Independent statistician
- Organizational logistics covering both EU and US territories
- Charter design or review
- Safety and interim efficacy analyses:
- Design of templates
- Data transfer from all parties: Sponsor, CROs, central laboratory, etc
- Data quality review
- Blinded or unblinded analyses
- Tables, figures and listings for interim analyses
- Writing of blinded/unblinded reports
Deep Data Monitoring Committee Expertise:
- IDDI dedicates a portion of its biostatistics team to IDMC support: (experienced biostatisticians serving as independent statisticians, experts serving as DMC Members).
- They fully understand the DMC objectives of protecting patients, are able to find dose-limiting or trial termination signals, and work hardly to separate adverse events from the disease process.
- They are true experts, delivering only what the committee members need in a succinct, complete and reproducible fashion. Our years of experience supporting multiple DMCs have positioned us to develop a clear, precise report format that enables swift and thorough review of reports by DMC members, who assess the risks and benefits of the study interventions in a timely and efficient manner.
- They deliver unbiased analyses thanks to their deep knowledge of interim analysis methodology, clinical trial methodology and FDA and ICH guidelines for safety reporting and DSMB.
- Thanks to their extensive experience in DMCs, they are highly knowledgeable about relevant biostatistical methods associated with interim analyses, including sequential designs, group-sequential designs, adaptive designs, conditional power and futility calculations, and sample-size adjustments.
Secure Data Sharing using a secure portal: ShareFile (powered by Citrix)
- A secure data sync and sharing service with flexible storage options and access rights
- Supported by IDDI helpdesk: firstname.lastname@example.org
- Encrypts data over the web integrating stringent security requirements