An adaptive clinical trial consultant or pharmaceutical consultant who writes clinical protocols will benefit by remaining up-to-date on the state of adaptive clinical trial design.
Charles Jaap’s latest white paper defines the concept, explains the history, and describes some of the advantages and disadvantages of adaptive trial design.
Adaptive design can increase the odds of success of a clinical development program, speed the time to approval, and improve investigational patient outcomes.
However, because of the added complexity and forethought, clinical trial consultants are critical to the successful deployment of such programs.
PDG routinely designs Phase I-IV clinical trials, including adaptive design. It also selects, validates and qualifies CROs on behalf of its clients. As a result the firm has increasingly been called on to provide regulatory strategy and oversight of CROs.
To learn more about the background and current state of adaptive clinical trial design, please feel free to download the white paper Clinical Trial Consulting, Pharmaceutical Consulting and Adaptive Clinical Trial Design.
If you need immediate assistance with your 505(b)(2) or other FDA submission, or meeting with the FDA, complete the information in the inquiry field to the right or give us a call at +1 813 419-PDG1 (7341).