CTMG will celebrate its tenth anniversary as the world’s first Site Specific CRO (‘SS-CRO’). This unique entity has provided unparalleled speed and certainty to Investigative Site clinical trial completion timelines. As described in the Food and Drug Law Institute’s Food and Drug Policy Forum (http://www.fdli.org/resources/resources-order-box-detail-view/can-fda-accelerate-clinical-trial-timelines-and-completion-using-documented-cgmp-processes-), the SS-CRO model provides design-reviewed processes that translate a Sponsor’s protocol requirements into discreet, measurable steps. These steps are conducted with CTMG’s real time quality system review as the data is acquired and ensures that what is intended in a Sponsor’s protocol is actually done at the Investigative Site– and done per timeline forecast. This controlled design-reviewed environment results in Investigative Site time efficiencies, superior quality data collection, lower direct clinical trial costs, acceleration of study completion times by 1-3 years, and credible data submission to FDA, thus allowing rapid approval decisions.
CTMG created this model and opened its doors on April 1, 2004. Our model is a unique entity in the clinical trial space, and was initially thought of as a Site Management Organization (“SMO”) because of our Business Associate partnerships with our Network Investigative Sites. In order to bring our disruptive innovation systems into the contracting process, we identified ourselves as a “Site Specific Contract Research Organization” (“SS-CRO”).
This terminology helped Sponsors realize the value of our systems, and utilize CRO contracting templates that address these system costs, as opposed to SMO contract templates that do not. While the term “SS-CRO” was very helpful in bringing the value of our systems into the contracting process, we have found it tends to obscure the position our approach actually plays in accelerating superior quality data acquisition. CTMG is not a traditional CRO, as we are not agents of Sponsor. We are a unique entity that contracts with Sponsors to create, develop and implement our cGMP-like processes at our Network Investigative Sites to complete their protocol requirements.
To remove confusion, CTMG will now identify itself as a “Site Specific Research Organization” or “SSRO” to more clearly define our service model differences from either the traditional CRO or SMO. It is our belief that this terminology change will more clearly convey CTMG’s position within the larger scope of clinical trials.
If you have any questions, or would like to discuss how CTMG can help in your clinical trial success, please contact us.