Vita-D S P

The secret to NCR's success is the quality of our staff and how we organize ourselves to carry out our work. We have compartmentalized the research process into logical elements, matched the skills and abilities of our staff to these elements, and then integrated them in a highly coordinated, efficient process. The most important element, the execution of study protocols, is filled by our clinical research coordinators; other staff members are positioned to support the CRCs efforts. This model of task assignment coupled with the experienced, well trained, and dedicated staff we have results in a product that is high quality and efficient. NCR's Clinical Research Coordinators: The most important persons in our organization are the clinical research coordinators ( CRC ). They are supported in their work by CRCs in training, research assistants, laboratory staff ( see below ), recruitment staff ( see below ) and regulatory staff ( see below ). Each CRC is a member of a team which typically consists of 2 CRCs and 1-2 research assistants. This redundancy assures capacity to handle the workload and assure continuity. Each research team can conduct a wide range of research studies, but tend toward specialization ( e.g. diabetes/metabolic, dyslipidemia/heart disease, pain, women's health, etc ). Our CRCs have an average of 6 years experience in clinical research. Most are degreed RNs with practice experience which assures knowledgeable assessment and triage of study patients. Most CRCs have completed the certification exam. Some of our RAs will advance to a CRC in training where they will be given their own studies to coordinate under the mentoring of a CRC. Once they have done this for at least a year and have successfully completed their CRC certification exam, they are promoted to a CRC position. NCR's Physician Investigators: At NCR, physician investigators participate in the day-to-day execution of protocols and assure the study patient's safety, but do so in the context of helping the CRC run the best study he/she can. NCR's full-time physician investigators are board certified in internal medicine and have 5-8 years of experience in clinical research. Because of their hands-on approach, our physicians are knowledgeable about the details of research protocols and study subjects and are readily accessible to sponsors and CRAs. NCR's collaborating physician investigators ( those who active medical practices in the area ) specialize in internal medicine/family medicine, cardiology, dermatology, gastroenterology, and obstetrics and gynecology and assist NCR with patient recruitment, qualification, and specialized study procedures. Regulatory services: In close harmony with the CRC, a regulatory specialist executes all study-related regulatory documents within 2 working days of receipt and maintains correspondence regarding regulatory matters with the Sponsor and IRB during the study process. The regulatory specialist also manages NCR's written standard operating procedures ( SOPs ) which helps us ensure compliance with GCP and ICH guidelines ( as well as OSHA and HIPPA requirements ). Laboratory: NCR's laboratory specialists are responsible for obtaining and processing all study- related samples per protocol in support of the CRC responsible for the protocol. NCR's Research Dietitian: NCR's full-time registered dietitians provides nutritional counseling for lipid, weight loss, and diabetes studies and completes study-related nutritional analyses in support of the CRC responsible for the protocol. Business support: NCR's business office processes study agreements and budgets within 2 working days of receipt. It tracks study progress and patient accrual through a state-of-the-art network computer system which allows resources to be allocated to CRCs as need and supports the electronic capture and transmission of research data to sponsors. Patient Recruitment: NCR employs full-time patient care representatives who develop advertising

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