Dynamic Trial Design & Dynamic Data Monitoring
A breakthrough approach for clinical trial design and management
Reshaping the Future of Clinical Trials
Dynamic Trial Design
Dynamic Trial Design (DTD) is a new method for designing and managing clinical trials. DTD expands on the FDA’s recent guidance on Adaptive Design for Clinical Trials to overcome the drawbacks of traditional Group Sequential Design and Adaptive Group Sequential Design.
Dynamic Data Monitoring
For Dynamic Trial Design to work, you need a Dynamic Data Monitoring (DDM) platform integrated with a full EDC/eClinical platform to collect, monitor and analyze data in real time which eliminates the need for lengthy Independent Data Monitoring Committees and Independent Statistical Groups. CIMS delivers a one-of-a-kind, patented DDM platform that utilizes machine learning and artificial intelligence to dynamically monitor and optimize your clinical trial.
Our full eClinical platform provides the EDC and Interactive Web Response System (IWRS) to capture patient data and manage treatment assignment. Our EDC and IWRS are integrated with the CIMS DDM to create a closed system that runs the complex statistical and mathematical computations and simulations.
DTD, DDM and eClinical with IWRS
Dramatically Improve the Drug Development Process
How DTD with DDM, EDC and IWRS Impact Drug Development
With the CIMS closed system, you can typically determine if your drug is working, or failing, in half of the time of the current standard.
- Optimize your on-going trial to maximize its success
Early termination of “hopeless” trials
- Receive alerts to conduct a formal futility analysis, enrich your population or modify your sample size
- Timely terminate a “hopeless” trial
Drug safety detection
- Continue monitoring drug safety and signal detection
- Optimize a phase 2/3 combination trial by identifying potential doses for phase 3
- Intelligently identify the most effective subpopulation
- Apply to an RCT or RWE setting for personalized medicine
Sample size re-estimation
- Intelligently estimate an optimal sample size to maximize the probability of success
Model checking and correction
- Check and verify the assumptions set prior to the initiation of the trial
- Implement corrections as the trial moves forward
This is the Dynamic Data Monitoring engine at work – the machine intelligence and AI.
See Dynamic Data Monitoring in action
The CIMS DDM is backed by published research.
Our eClinical platform contains 8 modules
Compare DTD to the current standards of traditional Group Sequential Design (GSD) and Adaptive Group Sequential Design (AGSD)
The CIMS DTD and DDM were developed by industry pioneers
“We’re implementing Dynamic Trial Design in our upcoming study and expect it to reduce our trial costs by a significant amount.”
— Bob Smith, VP of Clinical Development, DS Biopharma