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Research Center Profile:
High Point Clinical Trials Center

Therapeutic Areas

Endocrinology
Family Medicine
Healthy Volunteers
Neurology
Psychiatry/Psychology

Center Overview

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.

Facility Description

  • Our trial staff is made up of physicians, registered nurses, trial managers, phlebotomists, and clinical research professional
  • Hands on Medical Director/Principal Investigator who has participated in over 220 Phase One Clinical Trials
  • Medical Staff comprised of two full time MDs and a full time Physician Assistant.
  • Director of Clinical Services with 20 years of Clinical Research experience
  • Director of Research Operations with experience in over 200 Clinical Trials
  • Full time Research Pharmacist
  • Dedicated Regulatory Specialist
  • Dedicated Data Entry Specialists
  • Screening Department led by Screening Director with experience in over 100 Clinical Trials.
  • Recruitment Department
  • State of the art call center
  • Marketing and Recruitment Manager with 20 years of trial experience
  • Extensive healthy and special population volunteer database with high study retention rate
  • New state of the art 42,000 square foot facility
  • Spacious rooms with 70 bed In-patient capacity
  • High speed internet accessibility for in-patient population
  • Recreation room for subjects with Video Game and Movie Library
  • Fully equipped glassed in Nurses Station with full visualization of entire activity area
  • State of the art call center for subject recruitment
  • Temperature and Humidity monitored Laboratory and Pharmacy
  • Locked Freezers : -80°C (x4), -30°C (x4) and -20°C (x1)
  • Ambient and refrigerated centrifuges
  • Locked ambient and refrigerated storage for investigational products
  • Secure document archival/storage with FM-200 suppression system
  • Secure climate controlled server room with FM-200 suppression system
  • Doors are monitored by a computerized security system and the access is limited throughout with electronic keys customized per individual
  • Back-up diesel-fueled generator
  • Off-site back-up of all electronic data daily
  • Emergency equipment: AED, oxygen and defibrillator
  • Individual rooms with internet and phone access for clinical research associates/study monitors
  • 24 hour security during clinical trials and camera surveillance
  • Convenient location close to major airports and highways

Staff Expertise

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.

Contact Center

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