CLINILABS PROVIDED CENTRAL SCORING SERVICES TO SUCCESSFUL PHASE III VANDA STUDY
– Clinilabs, Inc. provided centralized data processing services to Vanda Pharmaceuticals Inc., a biopharmaceutical company, for a Phase III study of tasimelteon (VEC-162), an investigational drug for the treatment of sleep disorders.
As a CRO that specializes in centralized data processing, Clinilabs was chosen as the provider for Vanda’s Phase III trial. During this multi-center, placebo-controlled, randomized trial, 322 subjects with chronic primary insomnia received either tasimelteon or placebo over a four-week period. At the end of the four-week trial, adult patients with chronic insomnia showed a significant improvement in sleep.
“It was our pleasure to work with Vanda. Clinilabs has developed centralized data processing methods that reduce data collection errors, minimize variance in datasets, and standardize data analysis, ultimately enabling sponsors to detect meaningful difference between drug conditions when they exist. It was a privilege to deliver these services to Vanda. We congratulate Vanda, like many of our other clients, for its successful program” stated Dr. Gary Zammit, President & CEO of Clinilabs.
Mihael H. Polymeropoulos, M.D., Vanda’s President and CEO commented, “We are pleased with the support from Clinilabs and look forward to working with them again.”
For sponsors looking for an extraordinary CRO to support data services for domestic and global multicenter trials, Clinilabs is the vendor of choice. The Company provides specialty scientific consulting for clients who are developing drugs for sleep, psychiatric, neurologic, and cardiac indications. For large trials such as Phase III, Clinilabs is able to tap into a vast and diverse database of trained, certified investigators; enabling sponsors to enroll appropriate patients quickly and efficiently, resulting in high enrollment and retention rates.
Clinilabs is a specialty contract research organization (CRO) that provides a full portfolio of services to pharmaceutical, biotechnology, and medical device companies involved in early phase drug development, with specialty services in central nervous system (CNS) and cardiovascular (CV) therapeutics. The Company also provides data management for multicenter trials through a core data center that delivers services efficiently, promptly, and cost effectively. Established in 2001, Clinilabs has provided services to more than one third of the world’s top 20 pharmaceutical companies, and has been involved in 7 successful New Drug Applications (NDAs). For more information, please visit www.clinilabs.com.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders. For more on Vanda Pharmaceuticals Inc., please visit http://www.vandapharma.com.
Jeanine M. Estrada
212-981-2716
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