Axio® Independent Data Monitoring Committee
Independent DMC Solutions, Tailored to Your Needs
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.
Successfully managed 1000+ IDMC projects, across all major therapeutic areas
Broad biostatistics experience underpinned by industry-leading software ACES
Over 40 years of experience and expertise in safeguarding patient safety and trial integrity