Partner with IDDI for uncompromising excellence in interim analysis and IDMC services that ensure patient safety and trial integrity at every turn.
Do You Need an IDMC?
In clinical research, patient safety and data integrity are paramount. An Independent Data Monitoring Committee (IDMC) – sometimes referred to as a Data and Safety Monitoring Board (DSMB), Data and Safety Monitoring Committee (DSMC), or simply Data Monitoring Committee (DMC) – is an unbiased approach to safeguard patients, periodically evaluating safety and efficacy data to make recommendations on whether a trial should continue, be modified, or stop early.
IDDI biostatisticians have assisted over 300 IDMCs by employing statistical methods related to interim analysis, including group sequential design, conditional power and futility analysis, adaptive designs, and sample size re-estimation.
Comprehensive IDMC Services
Our interim analysis – IDMC offering includes:
IDMC Charter development
Simulation-based forecasting tools
Interim efficacy and futility analysis
Conditional power calculations
Unblinded and blinded sample size re-estimation (SSRE), including promising zone methods
Regular safety report production
Participation in open and closed meetings with results presentations
Secured sharing portal
Negotiate/execute IDMC members consulting agreements in conjunction with sponsor
Schedule and coordinate IDMC kick-off meeting
Attend the IDMC kick-off meeting
Write and/or review the IDMC Charter
Write the mock tables
Write and/or review the IDMC SAP
Program and quality control all analyses planned in the IDMC report
Produce dry run reports and review with sponsor as needed
Schedule and coordinate regular IDMC meetings
Produce and distribute open/closed IDMC reports to the sponsor and IDMC members
Distribute PV reports (Narratives, CIOMS) to IDMC members
Program and quality control any additional analyses requested by the IDMC
Attend the Open/Closed sessions of the IDMC meeting
Write the open and closed minutes
Process IDMC members invoices
Close-out – Archiving
Expertly Managed Interim Analyses – IDMC Services
Ensure the success and integrity of your clinical trials.
