CTMG has done what one former Global Vice President from a top ten pharmaceutical company called “impossible!”—we have successfully applied cGMP (current Good Manufacturing Practice)-like systems to Physician Investigative Site operations, re-defining Site performance.
Applying cGMP’s rigorous design-reviewed processes that translate a Sponsor protocol into discrete measurable steps, Adaptive Investigative Site Management® removes the risk of non-performance that currently characterizes 86% of Investigative Sites.1 As an SSRO, CTMG implements our proprietary quality review systems that ensure these protocol tasks are completed as intended at the Physician Site.
Our forecast study timeline has been met 100% of the time since 2008 when Sponsors utilized CTMG’s full AISM service.
- Upon receipt of a Sponsor protocol, CTMG’s eleven service teams conduct a high level protocol analysis to determine operational feasibility.
- A positive assessment will begin our inter-departmental process creation (utilizing industry design-review techniques) that translates the specific protocol requirements into discrete measurable steps.
- Completion of these steps at our Business Associate Physician Investigative sites is ensured by CTMG personnel, working side-by-side with the investigators, and our real time quality system review.
- Quality system review begins at the site, as the data are collected, and continues throughout the day with continuous monitoring of each patient’s progression through the “next process step.”
- Barriers to each patient’s next step are rapidly identified and eliminated within hours to ensure that completion of the protocol as intended is accomplished on time.