Interim Analysis – IDMC

Safeguard Your Clinical Trial With a Premier Provider of IDMC Services

In clinical research, patient safety and data integrity are paramount. An Independent Data Monitoring Committee (IDMC) takes an unbiased approach to your trial quality, ensuring validity and safety at every turn.

A unique combination of experience and expertise position IDDI as a premier provider of IDMC services.

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Our IDMC Experience

For over 250 IDMCs, IDDI biostatisticians have assisted committees by employing statistical methods related to IDMC and interim analyses, including sequential designs, group-sequential designs, adaptive designs, conditional power and futility calculations, and sample-size adjustments.

We deliver only what committee members need, in a succinct, complete, and reproducible fashion.

1,400+

Clinical Trials

280+

IDMCs

30+

Years of Experience

Comprehensive IDMC Services for Your Clinical Trial

This includes: 

  • Development of the IDMC Charter  
  • Simulation-based forecasting tools  
  • Production of interim analyses  
  • Efficacy and futility calculations  
  • Conditional power calculations 
  • Sample size adjustments 
  • Production of regular safety report 
  • Participation in open and closed meetings with presentation of results 
  • 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/review the IDMC Charter (Stat)  
  • Write the mock tables (Stat)  
  • Write/review the IDMC SAP (Stat) 
  • Program and QC all analyses planned in the IDMC report (data transfer to be planned in advance to allow the programming)  
  • Produce a dry run report (before the first IDMC report, before each IDMC report)  
  • Schedule and coordinate regular IDMC meetings  
  • Produce and distribute open/closed IDMC reports to the sponsor/IDMC members  
  • Distribute PV reports (Narratives, CIOMS) to IDMC members  
  • Program and QC any additional analyses requested by the IDMC  
  • Attend the open/closed sessions of the IDMC meeting  
  • Write the open minutes  
  • Write the closed minutes   
  • Process IDMC members invoices Close-out – Archiving  

IDMC to Ensure the Integrity of Your Clinical Trial

Ensure the success and integrity of your clinical trials with IDDI’s expertly managed Interim Analyses – IDMC services. 

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