Isis Pharma Utilizes Site Specific CRO for Study
The New England Journal of Medicine recently published results of a multi-center Phase II clinical trial, managed by CTMG.
The New England Journal of Medicine recently published results of a multi-center Phase II clinical trial, managed by CTMG-a site specific research organization (SSRO)--examining the safety and efficacy of Isis Pharmaceuticals' novel antisense drug, volanesorsen, in treating patients suffering from hypertriglyceridemia (severely elevated triglyceride levels). The study used CTMG’s protocol-specific processes, internal quality systems and proactive reaction time in identifying and eliminating barriers to continued patient participation, ensured all qualified patients were enrolled within nine months, with nearly all completing the year-long study, and providing high quality data for FDA review.
