Baltimore, MD (PRWEB) September 06, 2016
Shin Nippon Biomedical Laboratories, Clinical Pharmacology Center, Inc. (SNBL CPC), a leading early phase clinical research organization, continues to provide the best quality early stage clinical development services to sponsors. As a certified iCardiac site, SNBL CPC demonstrates commitment to their clients by offering the best, state-of-the-art services.
In December 2015, the International Council for Harmonisation revised the guidance that defines and enables an alternative path to the conduct of a Thorough QT (TQT) study. The new revision emerged following a prospective validation study in 2014 that was sponsored by iCardiac Technologies, Inc., utilizing iCardiac’s unique Early Precision QT methodology as well as its project management and analysis personnel. Sponsors working with an experienced iCardiac site using Early Precision QT, like SNBL, can potentially save millions in TQT study costs by obtaining critical information about their compounds earlier in development.
SNBL chose to become certified to conduct trials using iCardiac Early Precision QT to bring value to sponsors in countless ways. The patented iCardiac process was created after 30 years of research and allows sponsors ~10x more data than conventional measuring processes. Sponsors using this methodology can look forward to not only more data, which results in significantly less measurement variability, but also data which is less affected by signal noise and heart rate effects.
An extensive certification process is completed before becoming a certified iCardiac site. SNBL underwent training and testing in the following areas. On-site training by iCardiac personnel, site training for multiple key personnel, equipment deployment leveraging the same ECG/Holter acquisition technology utilized in the validation study, and demonstrated ECG precision to meet the highest quality standards. The high precision cardiac safety assessment methodology raises the bar for accuracy in clinical trials. SNBL and iCardiac look forward to a continued relationship of innovation and precision in shared clinical trials.
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 at chickey(at)snbl-cpc(dot)com, the client service team at bd(at)snbl-cpc(dot)com or visit http://www.snbl-cpc.com.