UNBIASED INDEPENDENT EXPERTISE … The Key to Study Integrity & Patient Safety
Independent Data Monitoring Committees (IDMCs) are an essential component of many clinical research programs. To support this critical function, PROMETRIKA provides comprehensive IDMC services designed for biopharmaceutical companies that conduct their own clinical trials or that use a CRO.
Throughout our history, sponsors have engaged PROMETRIKA to execute the essential statistical analyses needed by IDMC boards. Today, our IDMC service brings together the full range of professional expertise that sponsors need, and produces the unbiased expert perspective that current clinical research programs demand. Our team provides the necessary support for the successful management of an IDMC. This includes charter development, independent statistical analysis of interim safety and efficacy data, comprehensive safety monitoring, preparation of IDMC reports, and coordination and documentation of IDMC meetings.
With many years of experience in monitoring and in statistical analysis of patient safety data, our statisticians and medical experts are capable and ready to recruit and engage external members of the highest caliber for IDMCs. The availability of two separate independent statistical teams places us in a strong position to address effectively any potential conflicts of interest.
- Establishment of outstanding IDMC boards from a global network of key opinion leader contacts in all relevant clinical specialties
- Oversight of all aspects of development of IDMC charters and statistical analysis plans
- Data analysis and preparation of IDMC reports, including safety analyses and interim efficacy results
- Hands-on participation of experienced medical specialists in the areas of drug safety and risk management
- Presentation of analysis results by PhD statisticians, who are voting or non-voting IDMC members
- Provision of support for the coordination and execution of IDMC meetings, including recording and maintaining meeting minutes of open and closed sessions