CTMG Adaptive Investigative Site Management

AISMHeading

TraditionalModel

comparisonbreak

SSROModel

Adaptive Investigative Site Management® (“AISM”) and the Site Specific Research Organization (“SSRO”) Model

The Site Specific Research Organization (“SSRO”) is a proven, although novel, model to provide new efficiencies to clinical trial conduct. Clinical Trial programs utilizing the SSRO service with physician investigative sites are provided with faster patient enrollment, superior data, and an overall faster trial completion than programs utilizing the traditional model.

As an SSRO, CTMG implements cGMP-like proprietary systems at the point of data collection at the Investigative site. Deeply trained CTMG clinical quality and process staff work side by side with the physician investigators in the clinic to ensure all protocol requirements are completed as intended and on time.

Studies show that 86%1 of Investigative sites do not enroll contracted patient numbers within specified times, and enroll 1 or fewer patients. CTMG eliminates this undue risk for Sponsors and CROs by providing real time layered quality review of all data and operational tasks originating from CTMG-managed sites.

The SSRO model is a complementary service to CRO Risk Based Monitoring.

 

  • As an SSRO, CTMG is not competitive with traditional CRO services.
  • Rather, as a Business Associate of the Physician Investigator, we assist the site by providing the personnel and proprietary systems to “push” the study data out to the CRO and Sponsor monitors.
  • Working side-by-side with our Physician Investigators, CTMG’s AISM replaces the unstructured clinical trial environment normally found at Investigative Sites, with the most effective process control systems in the industry.
  • Such quality system-based structure at the physician site enables the CRO and Sponsor to complete their portion of study requirements with speed and certainty—at significantly reduced cost.
  • CTMG’s AISM results in the clinical trial “starting closer to the finish line.”

1http://www.sas.com/en_in/whitepapers/optimizing-clinical-research-operations-105164.html