Site Specific Research Organization partners with Isis Pharmaceuticals on Phase II trial

By Zachary Brennan

- Last updated on GMT

Site Specific Research Organization partners with Isis Pharmaceuticals on Phase II trial

Related tags Clinical trial

The completion of the Phase II study of Isis Pharmaceuticals’ novel antisense drug, volanesorsen, in treating patients suffering from hypertriglyceridemia included a collaborative effort between Isis and CTMG, which claims to be the world’s first Site Specific Research Organization (SSRO).

The success of the trial, which has helped Isis to launch a Phase III trial, comes as the CTMG-managed sites are able to rapidly enroll five to 30 times more patients per month than other physician sites, “yet still produce superior quality data​,” Anton-Lewis Usala, President and CEO of CTMG told 

The SSRO model under which CTMG operates aims to bring engineered protocol-specific operational processes to partnering physician investigative sites. And the sites can have these processes implemented under CTMG’s quality systems as the patients are being treated. 

Usala explained how the SSRO’s “contractual arrangements with our Business Associate physicians allow CTMG enrollment staff to identify (through remote patient EMR [electronic medical record] access) those patients that fully fit the protocol inclusion/exclusion criteria prior to contract signing​.”  

With eleven service teams continually reviewing trials, CTMG also helps to accelerate the moving of validated data from each contracted site to a sponsor’s CRO (contract research organization), which can boost the CRO’s ability to monitor and complete the study. 

If the CTMG claims prove true as they did for Isis, they could be boon to CROs and sponsors alike, which have struggled with the fact that 60-70% of physician investigator sites are under- or non-performing in enrolling patients and/or submitting data for entry into statistical analysis. 

CTMG also says it comes with a money-back guarantee. “If CTMG doesn’t provide deliverables of value (randomized patients and superior quality data), we return system cost payments to the Sponsor Company, and the expense is on us​,” Usala added.

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