CTMG’s Core Network Site Service provides our comprehensive Adaptive Investigative Site Management® at CTMG-Qualified Network Sites.
Since 2008, 98% of CTMG’s Core Network Sites have achieved or surpassed contracted patient numbers on or before the originally forecast timelines.
The success of our Core Network Sites begins with the most rigorous qualification process in the industry.
- CTMG experts in process engineering, clinical operations and quality systems conduct seven separate qualification visits to examine existing site operational systems.
- These service team members determine the feasibility of integrating CTMG proprietary processes and systems into the site’s ongoing processes.
- Utilizing these systems, CTMG has removed the risk of poor investigative site performance at our Core Network Sites.
Our Network physicians are contractually obligated to follow our proprietary processes, and respond to any queries or operational barriers identified by CTMG’s real-time and layered system review. CTMG’s Clinical Research Coordinator (“CRC”) staff work side-by-side with the Physician Investigators at each patient visit to ensure that meticulous preparation, implementation, and review of study visits occurs as intended. CTMG prepares and maintains regulatory, financial, contract, quality and clinical study documents, and provides secure transport between CTMG offices and Investigative Sites as needed for patient visits.
CTMG converts all paper study documents to un-editable digital image under 21 CFR Part 11 compliance. These files can be viewed remotely by Sponsor, monitors, and Physician Investigators through password-protected encrypted access. This enables a majority of study monitoring visits to be conducted remotely, thus reducing the typically large monitoring visit costs, while keeping the required monitoring timelines in sync with rapid enrollment and study completion.
Many larger Phase 3 and specialty studies are conducted using a combination of Sponsor selected Investigative Sites along with CTMG Core Network Sites. CTMG Core Network Sites are “Super Site Enrollers” that provide 5-30x more patients per site than traditionally managed sites (and thus 1/10 the number of Investigative Sites are required to complete the study).
CTMG can provide our Sponsor Site Selection and Optimization Service (Sponsor Site SOS) whereby CTMG remotely manages operational and quality systems at Sponsor-selected sites to guide and assist the site’s Clinical Research Coordinators
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