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Following the completion of extensive pilot studies involving over 3,000 subjects in several clinical trials, CSM announces results demonstrating the effectiveness of its pioneering services in improving subject retention and compliance.
FARGO, ND -- May 11, 2005 -- Following the completion of extensive pilot studies involving over 3,000 subjects in several clinical trials, CSM announces results demonstrating the effectiveness of its pioneering services in improving subject retention and compliance.
These services employ a team of Clinical Trial Research Pharmacists (CTRP) who serve as a critical communication link between all clinical trial stakeholders (sponsors, CROs, investigators, subjects) throughout the trial, 24 hours a day, 7 days a week. CTRP are licensed pharmacists with expertise in clinical trials, drug issues, and subject counseling. Analysis of data collected during the pilot phase indicates that CTRP counseling helped studies meet or exceed expected subject retention rates in every case. In addition, over half of enrolled subjects per trial had a critical intervention, defined as a CTRP intervention that if left undetected or uncorrected would have compromised the quality of the data point.
The pilot studies showed that CTRP services benefited not only the sponsors, but other key study team members as well. Site monitors noted that the frequent CTRP reports helped escalate and resolve critical subject issues in a timely manner, while clinical research coordinators reported that the personalized service of the CTRP team and their 24/7 availability greatly improved communication and subject satisfaction in the studies.
"We are excited about the data from our pilot studies--it confirms the value of the service. In light of the FDA's recent critical path initiative to speed up the drug development process, we feel that CTRP services are needed now more than ever to facilitate the process, support good subject care, and ensure the best clinical data possible," said Tina Schlecht, Pharm.D., Vice President, Retention and Compliance Services.
CTRP services are currently available domestically and will benefit any clinical trial, especially those that involve a complicated drug regimen, dose titration, or use of a medical device to administer drug, or in trials where subject retention or compliance with protocol directions is critical.
CSM is a clinical trial support services company committed to advancing clinical trials for pharmaceutical and biotechnology companies by providing innovative and customized services in the areas of clinical supplies and subject retention and compliance.