Baltimore, MD (PRWEB) June 22, 2013
SNBL Clinical Pharmacology Center, Inc. (SNBL CPC) is pleased to announce a new addition to its early-phase drug development services through a partnership with the Centre for Human Drug Research (CHDR). CHDR’s NeuroCart is a versatile test battery that quantifies the physiological and psychological effects of CNS-active compounds in a flexible, protocol-specific manner. SNBL CPC is proud to be the exclusive offeror of the NeuroCart in the United States.
The NeuroCart was developed by CHDR, a Dutch company, through 20 years of practical application and clinical trial experience, and has been used to test a wide variety of CNS-active compounds in the EU, including therapeutics for sleep disorders, psychosis, addiction and Alzheimer’s syndrome. Measured effects include alertness, memory, motor skills, general brain activity, and subjective assessments. These effects are quantified using the following features:
- Cognitive and memory testing
- Electroencephalography (EEG)
- Saccadic and smooth pursuit eye movement
- Adaptive tracking
- Finger tapping
- Body sway
- Visual Analogue Scales (VAS)
- Psychometric questionnaires
- ANS function tests (e.g. pupillometry, heart rate variability)
- CNS function tests (e.g. Symbol Digit Substitution test, Critical Flicker Fusion, Stroop Conflict Task)
A profile of the psychological and physical effects of CNS-active drugs is created by testing the drug through a selection of the modules above. This unique profile, which can be compared directly with plasma drug levels and side effects, provides invaluable information about the activity of the compound. The NeuroCart not only quantifies the pharmacological mechanisms of action of CNS-active drugs, but also gathers information on safety pharmacodynamics. The closely matched data management system, Promasys®, allows rapid production of quality-controlled, blinded reports to aid in dose-escalation decisions, or to allow databases to close sooner.
Takeshi Yamakawa, Chief Executive Officer of SNBL CPC, stated: “This collaboration provides the US marketplace a very unique way of assessing key neurological testing frequently needed in Phases I and II. The unique system, developed for integrating data and producing informative reports, will provide our clients with a leading edge advantage in the CNS arena of research.” Professor Joop van Gerven, director of CNS Research at CHDR, stated: "The CNS test battery NeuroCart covers all drug responsive CNS domains and is easy to integrate in early drug studies. The combination of efforts from CHDR and SNBL offers more innovative and worldwide services to our customers." Professor Adam Cohen, CEO of CHDR, stated: "The development of biomarkers in early discovery is essential to bridge preclinical and clinical development. To combine knowledge from two innovative CROs is vital in today's translational research."
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, 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 George Debski (gdebski(at)snbl-cpc(dot)com) or the client service team (bd(at)snbl-cpc(dot)com), or visit http://www.snbl-cpc.com.
CHDR is a full service contract research organization (CRO) located in Leiden, the Netherlands. CHDR provides a full spectrum of high quality clinical pharmacology services to the (bio-) pharmaceutical industry. CHDR’s main focus is performing data-intensive, early phase, clinical studies where pharmacokinetic and pharmacodynamic parameters are obtained and combined. CHDR also conducts its own research, aimed at the development of biomarkers, methodology and technology under strict GCP conditions. CHDR specializes in First-in-Human, Proof-of-Concept, and PK/PD modeling studies. To obtain PK/PD parameters we develop, validate and use the latest techniques to provide the most accurate and highest quality data in early phase drug development. CHDR has developed a range of methodologies to provide detailed information about the effects of drugs on the central nervous system (CNS), including the NeuroCart.