Baltimore, M.D. (PRWEB) December 29, 2015
SNBL Clinical Pharmacology Center, Inc. (SNBL CPC), a 96-bed clinical pharmacology research unit specializing in complex phase I/II clinical trials, announced today the successful enrollment of a fourth Japanese Bridging study, investigating the pharmacokinetics and safety parameters of an investigational product under an IND application
The study that recently completed enrollment was a single dose crossover study evaluating the intra-protocol pharmacokinetics, safety, and tolerability of the IP in 10 healthy adult Japanese male and female volunteers, and 10 healthy Caucasian male and female volunteers. All of the volunteers were enrolled into the study meeting timeline goals set by the sponsor. This achievement is highlighted by the fact that protocol entry criteria for Japanese ethno-bridging clinical trials are much more stringent today than in the recent past, verifying that SNBL CPCs recruitment strategies and access to patients is very effective.
SNBL CPC is an American subsidiary of Japan’s first early phase contract research organization, Shin Nippon Biomedical Laboratories (SNBL). Thanks to its Japanese roots, SNBL CPC is well-positioned to provide Japanese-style amenities and support to ensure appropriate care of Japanese subjects during these trials. Native-born Japanese-speaking support staff include a research physician who has been with SNBL CPC since 2006, a research nurse and several translators who assisted with recruitment and clinical conduct. Feedback from Japanese participants regarding their experiences throughout the trial has been positive, demonstrating the success of SNBL CPC’s approach to providing Japanese style care.
Vice President of Business Development
SNBL Clinical Pharmacology Center, Inc.
800 W. Baltimore St., 5th Floor
Baltimore, MD 21201
About SNBL CPC:
SNBL CPC is a 40,000 square foot, 96-bed clinical pharmacology research facility located in the University of Maryland BioPark in the heart of Baltimore, Maryland. Equipped with a state-of-the-art facility and bolstered by a vibrant research community, SNBL CPC specializes in complex Phase I-II trials, including TQT, FIH, and Challenge studies, in therapeutic areas including immunology/infectious disease, neurology, radiology, ophthalmology, endocrinology, and more. SNBL CPC conducts clinical trials from multiple sectors, including pharmaceuticals, biotechnology, academia, and the government. SNBL CPC offers full service support of clinical trials through its in-house resources, expert partners from surrounding universities and practices, and vetted subcontractors. These services include medical writing, patient recruitment, clinical conduct, regulatory submission, and data management.
For further information about SNBL CPC and how it can support your early phase drug development, please contact Christopher Hickey (chickey(at)snbl-cpc(dot)com) or the client service team (bd(at)snbl-cpc(dot)com), or visit http://www.snbl-cpc.com.