We solve problems with the goal of an informed IDMC recommendation.
Your Trusted Partner for IDMC Solutions
The increasing complexity of clinical development programs demands independent evaluation of interim clinical data through Independent Data Monitoring Committees (IDMCs) to safeguard patient safety and trial integrity. For over 40 years, our clients have trusted us to plan and manage more than 1000 data monitoring committee projects, including trials from industry, academia, and government. We carefully tailor our approach to match the unique requirements of each clinical trial. Our dedicated professionals are specifically trained to serve as independent statisticians, focused on providing expert IDMC-related services. We have expertise in all major therapeutic areas and experience in handling incomplete data, adaptive designs, and complex endpoints.
Independent Statistical Data Analysis Center for Adaptive Trials
The complexity of clinical trial designs and adaptive interim analyses are increasing. Axio and our Therapeutics Development Team are at the forefront of the design and implementation of these advances. Axio is the leading provider of independent SDAC services.
- Group Sequential Designs
- Bayesian Designs
- Conditional Power
- Sample Size Re-estimation
- Dose-selection
- Population Enrichment
IDMC Charter
A well-written charter provides clear guidance for your IDMC. We author and review IDMC charters for our clients following standard regulatory guidance as found in the FDA and EMA Guidance for IDMC Support and E9.
Design and program IDMC reports
A well-designed set of data summaries enables the IDMC to make efficient, informed, and appropriate recommendations. IDMC members expect graphical displays of data to concisely reveal and aid them in comprehending trends. We know what belongs in an IDMC report and we provide a single, concise, bookmarked document.
Meeting facilitation and data presentation
A clear recommendation based on accurate information is the desired outcome of a successful IDMC meeting. We effectively host over 400 IDMC meetings annually where we offer expert data presentation without micromanaging the committee.
Interim and unclean data handling
Properly addressing missing and unclean data issues is crucial to accurately presenting and representing data to the IDMC members. We employ defensive programming practices and examine each unique data package to understand their anomalies and structures.
IDMC member identification and organization
Having the right subject matter expertise in your IDMC membership is critical. We have relationships with an extensive global panel of experts, spanning all therapeutic areas, should you require assistance in building your committee. This service includes member contracting, honoraria handling, and training.
Contact Us
Contact a Cytel representative and ask for more information about Axio® independent DMC services.
