CTMG provides the same operational and quality systems to Investigative Sites outside of our CTMG-qualified Core Network through our Sponsor Site Optimization Service (“Sponsor SOS”).
Often a Sponsor needs specialized physician participation not just based on medical subject-matter expertise, but on the ability of specific physicians to communicate with others in their profession (“thought leaders”), or to leverage historical research relationships. CTMG’s Sponsor SOS enables these Investigative Sites not only to contribute to these Sponsor goals, but also optimize their site’s enrollment and study completion capabilities.
Determining whether a Sponsor’s chosen site is an operational fit with CTMG’s systems is quickly accomplished after a Sponsor introduction to the Site Principal Investigator (PI). Most PIs and their staff are very happy to meet with CTMG by phone, and then in person, when they learn CTMG can efficiently complete such time consuming tasks as Regulatory Pack submission, source document development, contract and finance drafting, and most importantly, pre-screening of patients to identify those that fit Sponsor protocol inclusion/exclusion criteria.
CTMG will discuss our assistance services that can be provided only as Business Associates of the PI. Senior CTMG staff will visit the PI site to conduct a “Site Operations Match Determination.”
- The Site Operations Match Determination is an accelerated CTMG qualification process requiring only 1-3 days to complete.
- Within 10 business days of completion, CTMG sends a report discussing each Site’s current capabilities specific to the study protocol, as well as potential barriers to efficient study completion or high enrollment.
- • Specific CTMG interface suggestions, designed to accelerate Site performance utilizing CTMG operational and quality systems, are detailed in the report. If Site and Sponsor are in agreement with a plan to move forward, CTMG will sign a Business Associate agreement with the site, and will provide the proprietary services designed to offload site staff of operational tasks.
If Site and Sponsor are in agreement with a plan to move forward, CTMG will sign a Business Associate agreement with the site, and add it to the daily operational and data quality review roster to assure maximal increase in site enrollment and performance.
Feel free to Contact Us if you have any questions about this service.
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