Data Monitoring Committees (DMCs)

As a trusted DMC partner, MMS provides the infrastructure, expertise, and governance essential for effective oversight. Our flexible and collaborative approach ensures alignment with all stakeholders from sponsors and steering committees to regulatory bodies throughout the DMC lifecycle. 

• Charter & Protocol Development
  MMS collaborates with sponsors to draft detailed DMC charters outlining objectives, operations, review schedules, and decision-making criteria. 
• Interim Analysis & Reporting
  Our independent statisticians and programmers generate blinded and unblinded datasets and conduct interim analyses in alignment with pre-specified analysis plans and regulatory expectations. 
• Dedicated Statistical Expertise
  MMS provides experienced DMC statisticians with therapeutic area expertise to support safety and efficacy evaluations, sample size reviews, and adaptive trial decisions. 
• Confidential, Compliant Communication
  We ensure timely delivery of recommendations to trial steering committees, regulatory bodies, and IRBs without compromising trial blinding or data security. 
• End-to-End Coordination
  MMS seamlessly supports the DMC workflow, from protocol development to ongoing data reviews. We deliver high-quality, timely outputs, enabling confident, real-time decision-making throughout each trial. 

• Extensive DMC experience across phases and therapeutic areas 

• Strong regulatory knowledge (FDA, EMA, WHO guidance) 

• Proven data-driven operational models to support complex, global trials 

• Confidentiality and compliance embedded in every step 

• Agile support for adaptive trials including statistical modelling for early stopping (futility, efficacy) or modifications (sample-size re-estimation)  

• Seamless, confidential communication between the DMC and sponsor, providing the necessary data to make swift, informed decisions. 

MMS leverages Datacise ®, our proprietary clinical data platform, to enhance DMC operations through secure, real-time access to clean, curated data. By integrating interactive visualizations and predictive analytics, Datacise enables: 

• Faster, more informed interim data reviews 

• Enhanced signal detection for safety and efficacy 

• Greater transparency and confidence in decision-making 

MMS supports sponsors in assembling DMCs composed of: 

• Experienced clinicians and subject matter experts 

• Statisticians with robust DMC and therapeutic area expertise 

• Chairs skilled in leading deliberations and regulatory communications 

Our statisticians play a vital role in: 

• Contributing administrative input to ensure smooth and compliant DMC operations 

• Providing independent statistical representation on DMCs 

• Performing statistical data analysis to support DMC decision making 

• Reviewing safety signals 

• Analyzing efficacy trends 

• Interpreting and presenting interim data clearly and impartially 

• Advising on trial continuation, modification