High Point Clinical Trials Center is dedicated to providing the highest quality of Phase I and Phase II clinical trials service to the Pharmaceutical Industry and to our volunteers. Our team of trained experienced research professionals are dedicated to providing YOU and YOUR product the attention, commitment and professionalism required towards a successful and timely outcome.
High Point Clinical Trials Center is committed to the safe and ethical conduct of clinical trials for investigational drugs in a pleasant, comfortable environment for research participants in our new state-of-the art facility located in High Point, NC. We offer a variety of amenities for research participants. Our team of qualified and caring staff is dedicated to making miracles of medicine a reality.
MELANIE FEIN, MD, CPI, DABFM
Medical Director
Dr. Melanie Fein is an experienced Principal Investigator and Medical Director of Phase One Clinical Trial Units. Her goals are to maintain participant safety while ensuring study integrity and producing high quality studies in a timely and efficient manner.
Dr. Fein’s research experience includes participation as a Clinical Investigator in over 220 Phase One and Two Clinical Trials in multiple therapeutic areas.
Dr. Fein is board certified in Family Medicine and has the Certified Physician Investigator Certification. She has worked with several major pharmaceutical companies and smaller Pharmas and CROs, receiving multiple commendations on the conduct of her trials. Between 2008 and 2010, Dr. Fein had two FDA audits on studies in which she was Principal Investigator. No 483 was issued for either study.
A "hands on" investigator her experience and expertise includes clinical trial conduct, set up of Phase One operational and clinical systems and staff training in the implementation of clinical trial systems.
RICARDO A. SANCHEZ, RN, CCRC, FMG
Director of Clinical Services
Ricardo Sanchez obtained his Medical Degree In Columbia and was a Professor Of Surgery at Metropolitan University in Columbia. He obtained his Registered Nurse degree through New York State University in 1996 and is presently a Certified Clinical Research Coordinator.
Mr. Sanchez is a committed research professional who has extensive research experience spanning nearly two decades, having actively participated in over 650 Phase one, two, and three clinical trials in numerous therapeutic areas. Mr. Sanchez has supervised a number of clinical trial departments leading to a broad based knowledge of the entire clinical trial process. He has been in a managerial position for over 12 years, training and supervising staff in the conduct of clinical trials.
MARILYN RODERICK, RN, MD
Physician Investigator
Dr. Roderick has practiced primary care medicine for over twenty years, making her acutely aware of the importance of developing new drugs for use in clinical settings. She has also engaged in medical research activities in a variety of settings. These include hospitals data collection and analysis of hospital-acquired infections, a metabolic disease research unit-late phase studies, an academic medical laboratory-development of serologic assays for hepatitis B virus diagnosis, and two early phase drug development units.
NITA JOHNSTON, Pharm D, MS
Research Pharmacist
Dr. Nita Johnston Pharm D, MS holds a Doctorate of Pharmacy license from Campbell University and received her Masters of Science in Clinical Research Administration. Dr Johnston has been involved in clinical trials for the last twenty years in multiple therapeutic areas. She is dedicated full time to clinical trials at High Point Clinical Trials Center responsible for pharmacy management, all aspects of investigational product, and providing support to investigational staff and sponsors regarding study product, concomitant meds and blinding procedures.
ANTONIO GUZMAN
Clinical Trial Manager
Antonio Guzmán graduated with a medical degree from " Universidad Nuestra Señora de La Paz" school of medicine. Antonio has a strong background and understanding of medical aspects of clinical trials as well as experience as a coordinator in overseeing a number of Phase One clinical trials. His areas of expertise include overall study management including study conduct, subject safety, data collection and data entry supervision, staff training, quality assurance, screening and recruitment.
H. DAVID DUQUE
Director Research Operations
David Duque graduated with a medical degree from The “Universidad de Antioquia” school of medicine (Medellin, Colombia). He has more than 7 years of experience working in early phase research with major pharmaceutical and biotech companies in the United States, collaborating in a wide variety of phase I and phase II studies (more than 200 total) including First in Humans, Bio-Equivalence, Bio-Availability, Cardiac safety/Definitive QTc and Food Effect among others.
David Duque has held several managerial roles in multiple areas within the early phase research industry, including screening/recruitment, electronic source documentation, PK management, laboratory supervision, source document creation, data processing, clinical trial management and staff training.
ISSIS KELLY- PUMAROL
Screening and Recruitment Director
Issis Kelly- Pumarol Graduated from "Universidad Iberoamericana" School of medicine, Santo Domingo, Dominican Republic. Has dedicated most of her career to Clinical Research, from early drug development to post market research. With more than 6 years of experience, areas of expertise includes patient recruitment, screening, conduct of clinical trials and data collection.
SHEILA RASSETTE-EDWARDS
Marketing-Recruitment Manager
Sheila Rassette-Edwards has worked in marketing and recruitment for clinical trials for over 19 years, making her dedication to recruitment of research subjects her career. She holds a degree in Commercial Art and Advertising Design and is certified as a Clinical Research Professional. Sheila is responsible for patient recruitment and marketing and branding our research site.
