UNBIASED INDEPENDENT EXPERTISE … THE KEY TO STUDY INTEGRITY & PATIENT SAFETY
Independent Data Monitoring Committees (IDMCs) are an essential component of many clinical research programs. At PROMETRIKA, we provide superior, comprehensive IDMC services designed for biopharmaceutical companies that conduct their own clinical trials and those that use a CRO.
Our experienced team helps the sponsor quickly and successfully establish an IDMC with the necessary knowledge and background, and continues to support the IDMC as they perform their critical functions.
In collaboration with the IDMC and sponsor, we design concise, yet comprehensive reports that facilitate efficient and effective review by IDMC members, allowing them to make their recommendations with confidence. Throughout the process our team maintains the confidentiality of the data reviewed and decisions made by the IDMC to ensure the integrity of the trial.
Above all, our team is flexible and can work with the sponsor to customize the suite of services that best fits their needs.
OUR SERVICES
- IDMC recruitment and contracting
- IDMC coordination
- IDMC charters
- Interim statistical analysis plans
- Mock shells
- Separate teams to produce blinded and unblinded analyses
- Safety analysis
- Interim efficacy analyses
- Analysis for clinical trial adaptations
- IDMC safety and/or efficacy reports
- Unblinded statisticians to report to IDMC
- Archival of IDMC materials
- PhD level statisticians to serve on IDMC
“I oversee the work done by the dedicated teams to ensure a consistent approach to supply the IDMC with concise, yet comprehensive reports that allow the Committee to complete their review efficiently and make the recommendations with confidence.”
Neil Wohlford
