Ensuring patient safety and assuring study merit and integrity through the independent evaluation of interim clinical data is vitally important for increasingly complex development programs.
Axio has supported clients in the planning and management of more than 200 Data Monitoring Committees in all major therapeutic areas—making us one of the foremost companies in this field. Our staff members are highly trained to serve as independent statisticians for DMCs, and we apply this expertise and deep DMC experience to provide turnkey solutions for monitoring patient safety and ensuring trial integrity.
Our approach is to coordinate and manage DMC projects to fit the specific requirements of every clinical study and to serve as client liaison to the DMC—providing either a selection or the full complement of support services needed to facilitate efficient DMC operation.
In addition, to promote optimum review of our clients’ interim study data by their DMCs, we have developed a distinctively user-friendly, easily referenced report format and other innovations that ensure the clear presentation of data.
Our areas of experience include:
- Cardiovascular disorders and devices
- Inflammatory Diseases
- Infectious Diseases
- Pulmonary Disorders
Axio’s DMC services include:
- Committee member recommendation and contracting
- Preparation of the DMC charter
- Specification and preparation of interim analyses
- Designing and programming DMC reports
- Presenting open and closed DMC reports
- Completing meeting minutes
- Providing Institutional Review Board (IRB) notification documents
- Coordinating DMC meeting arrangements
Building a Better DMC Report
Our years of experience supporting hundreds of DMCs have positioned us to develop a clear, precise report format that enables DMC members to thoroughly review reports in a time-efficient manner. Hallmarks of Axio DMC reports:
- Advanced report formatting programs that enable creation of PDF files with linked indexes and content
- Expertise in selecting appropriate content and omission of distracting and/or irrelevant content
- Clear, uncluttered charts, graphs, and tables