An unbiased eye on patient safety and data integrity
Double-blind studies, conflicts of interest, unintentional bias—there are many reasons why sponsors and investigators might seek to shield themselves from results in progress. Our data and safety monitoring services (DSMS) provide the outside clinical analysis and judgment researchers depend on when they need independent monitoring of emerging results.
Data and Safety Monitoring Boards (DSMB) are vital safeguards for patients and sponsors alike. With the safety of trial participants and the credibility of the study at stake, a lot of trust is placed in the Board. With decades of experience in research protocols, WIRB offers the assurance that your study will be monitored by experienced, unbiased experts in the field.
Getting startedTo learn more and discuss your DSM needs, contact us.
How it works
DSMS works with sponsors and researchers to monitor the safety and efficacy results of research in progress. Typically, this involves setting up a committee of experts to look at the data at preplanned study landmarks. DSMS might specify the blinded or unblinded data to be evaluated by committee members, convene meetings to review the data, and provide recommendations and reports.
Customized services
Typically, we set up a customized arrangement with each client. We start by analyzing the study design and level of risk to assess the safety monitoring plan and help develop an appropriate approach to monitoring—such as the systematic and transparent flow of data to the committee, its size and composition, and study landmarks that trigger review. DSMS drafts a formal charter defining the structure and organization of the proposed DSMB, recruits and trains committee members, and administers the independent monitoring process.