• PHASE 0: (PK, PD and BD) NHCR will help the sponsor in Investigational new drug (IND) study and also known as a “micro dosing” study. NHCR will help sponsor to determine whether the agent behaves in humans as was expected from preclinical animal studies (Exploratory trials) to gather preliminary data on pharmacodynamics or pharmacokinetics, to select promising lead candidates, or to explore biodistribution characteristics. This will help the sponsor to speed drug development as part of the FDA Critical Path Initiative by quickly weeding out ineffective drugs early in the development process.
• PHASE I: NHCR will help the sponsor to determine the metabolism and pharmacologic actions of the agent in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy subjects and/or subjects with medical conditions.

Central Nervous System Drugs:

• Longer to reach the market
• Higher failure rate than many other therapeutic areas
• Difficulty getting the drug into the CNS
• Slow onset of many neurological disorders
• Difficult to assess Efficacy in early trials.

Imaging, CNS biomarkers, and adaptive trial design will help to show whether and how much of the drug reaches the target, along with indications of safety and efficacy in healthy volunteers and patients. This will allow go/no go decisions at an earlier stage; stratify patients into those most and least likely to respond, and direct the design of later studies and the development of drug delivery systems/formulations.

Specifics of NHCR in CNS

• CNS investigators have more than 75 years of combined clinical trial experience.
• CNS investigators are led by Duke/Glaxo-SmithKline Fellow in Neuro-psychopharmacology and New Drug development
• Study coordinators and Nursing staffs are well trained and certified in clinical research
• Fastest in entering Data and answering queries in every study
• Highest recruiting site in Phase II-IV studies
• Highest recruiter and best data Site Award from one of the largest CRO in 2014
• Well experienced in conducting PK, BA, BE studies
• Easy access to well equipped MRI, fMRI and PET (across our outpatient research center and have an excellent working relationship)
• Well placed in a city with multiethnic population to recruit diverse and trial naïve population
• Situated in the financial capital of the State
• Recruitment for study subjects and healthy volunteers are easy because of several Universities, colleges and nearly 100 community colleges.
• Two major tertiary hospital in arms away in an emergency situation.
• Fifteen minute drive to international airport
• Walking distance to a major hotel and restaurants

NHCR has investigators and medical consultants in every medical specialty.