Research Center Profile:
North Carolina Clinical Research

Center Information

Clinical Research Recruiter
North Carolina Clinical Research
2615 Lake Drive, Suite 301
Raleigh, NC 27607
USA
919-881-0309
919-881-9899 (fax)
tjohnson@NCCR.com
www.nccr.com
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Therapeutic Areas

Cardiology/Vascular Diseases
Gastroenterology
Healthy Volunteers
Immunology
Infections and Infectious Diseases
Musculoskeletal
Neurology
Obstetrics/Gynecology (Women’s Health)
Ophthalmology
Otolaryngology (Ear, Nose, Throat)
Pediatrics/Neonatology
Pharmacology/Toxicology
Pulmonary/Respiratory Diseases
Vaccines

Center Overview

North Carolina Clinical Research (NCCR) is an independent, multi-therapeutic outpatient clinical research site located in Raleigh, North Carolina. NCCR has conducted Phase I, II, III and IV clinical trials in both children and adults since 1986. We have completed over 550 studies in a variety of therapeutic areas for many different pharmaceutical companies and Clinical Research Organizations (CROs). The NCCR facilities and staff are dedicated 100% to Clinical Research.

We believe it is our dedicated staff at NCCR that makes our facility stand out above the rest. Our hardworking, passionate, friendly crew makes studies placed at NCCR a positive experience for both the sponsor and the patient.

Advantages we offer at NCCR:

  • Consistently meet or exceed enrollment expectations
  • Excellent patient compliance and retention record
  • Flexible scheduling for patients
  • Timely turnaround of regulatory documents and contracts
  • Utilize both central and local IRBs
  • Standard Operating Procedures in place
  • Emphasis on the use of Good Clinical Practices to meet each sponsor’s needs
  • Easy access to Investigators
  • Access to a metropolitan population exceeding 1 million, including 3 major universities
  • Research database of over 7,400 patients
  • Practice database of over 15,000 patients

Performance Metrics

Number of Studies Conducted: 580
Number of Studies Actually Completed: 580
Number of Active Patients in the Database: 7300+
Regulatory Submission Turn-Around Time: 1 Week(s)
Average Number of Total Patients Enrolled: 15
Average Percent of Total Patients Randomized: 90%
Average Percent of ‘Completed’ Studies that met Enrollment Goals: 99%
EDC Capabilities: Yes

Staff Certifications
Number of Certified CRCs: 5
Number of Certified PIs: 2

Clinical Research Experience

NCCR has been involved in clinical research since 1986. We focus on phase I, II, III, and IV research. We conduct research in the following areas:

  • Allergies
  • Asthma
  • Birth Control
  • COPD
  • Cough/Cold
  • Infectious Diseases/Anti-infectives
  • Label Comprehension and Actual Use Studies
  • Ophthalmology
  • Normal Healthy
  • Pain Management (headache, arthritis, muscle aches, sore throat)
  • Pediatric Allergy & Asthma
  • Quality of Life Studies
  • Cost Effectiveness Analysis
  • Hormone Replacement Therapy
  • IBS
  • Heartburn
  • High Blood Pressure 
  • High Cholesterol
  • Smoking Cessation 
  • Migraine
  • Pharmacoeconomic Studies
  • RX to OTC studies
  • Tension Headaches

We have worked previously with the following Sponsors and CROs:

  • Abbott
  • Adams Respiratory Therapeutics
  • Alcon
  • Alexa 
  • Allergy Therapeutics
  • Alkermes
  • Altana
  • Alza Pharmaceuticals
  • Amphastar
  • Aperon
  • Apotex
  • Array Biopharma
  • Ascent Pediatrics
  • Astellas 
  • Astra Merck
  • Astra USA
  • Baker-Norton
  • Barr Research Labs
  • Bayer
  • BioMarck 
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • Capnia
  • CE3 Inc 
  • Chiesi
  • Chiltern
  • Dey 
  • Clay Park Labs
  • Ciba Geigy
  • Dey Labs 
  • Dura
  • DuraMed Research 
  • Elevation
  • Emergent
  • Epigenesis
  • Forest
  • Fisons 
  • G.D.Searle
  • Genentech
  • GlaxoSmithKline
  • Greer Laboratories
  • Hoffman LaRoche
  • Icagen
  • Icon 
  • Inspire
  • Interspond
  • I3 Research
  • IVAX (Teva) 
  • Janssen
  • Kikkoman
  • Marion Merrell Dow
  • McNeil Consumer
  • Map Pharmaceuticals
  • Meda
  • MedImmune
  • Miles
  • MSD Consumer Care
  • Muro  
  • Mylan
  • Novartis
  • ONO Pharma USA
  • Organon
  • Perrigo
  • Pfizer
  • PGx Health
  • Pharmacia & Upjohn
  • Pharmanex
  • Pozen
  • PPD 
  • PRA
  • PRN
  • Procter & Gamble
  • Purdue Pharma
  • Quintiles
  • Reckitt-Benckiser
  • Rhone-Poulenc Rorer
  • Rigel
  • Roxane
  • Sankyo
  • Sanofi Aventis
  • Sanofi Pasteur 
  • Schering-Plough
  • Sepracor
  • Shionogi
  • Skye Pharma
  • Solvay Pharmacueticals
  • Sunovion
  • Sun Pharmaceuticals
  • Solvay
  • Syntex
  • Tap
  • Teva 
  • UBC
  • UCB Pharma
  • Upjohn
  • ViroPharma
  • Wallace Laboratories
  • Warner Lambert
  • Whitehall Laboratories
  • Whitehall
  • Wyeth-Ayerst
  • Zeneca

Facility Description

NCCR’s facilities (newly completed in 2008) include the following:

  • Located across the street from a major medical center
  • Individual monitor areas convenient to telephone, fax, copier and high speed Internet
  • Secured storage for ambient and refrigerated study drug
  • Conference room
  • Fully equipped lab
    • -70° C freezer
    • refrigerated centrifuge
    • Purifier biological safety cabinet (clean hood)
    • backup generator
    • Sensaphone temperature monitoring system
  • Convenient X-ray facility
  • Examination rooms (8)
  • Spirometry and methacholine challenge rooms
  • Treadmill (exercise challenges)
  • ECG capabilities
  • Easy accessibility to physicians
  • Patient lounge area for extended days
  • Infusion and PK capabilities
  • Overnight facilities with showers and individual sleep areas
  • Pollen reporting
  • Internet capabilities through T-1 access

Staff Expertise

Supporting our principal investigators in the completion of each study is a clinical research staff of more than 18 professionals including Sub-Investigators, Site Manager, Subject Recruiter, Regulatory Administrator, Clinical Research Coordinators, and Office Coordinator. Our team has over 245 combined years of Clinical Research experience.

Dr. Craig LaForce is the Medical Director of North Carolina Clinical Research.Dr. LaForce has served as the Principal Investigator for approximately 500 studies and a Sub-Investigator for a handful of trials as well. Dr. LaForce is Board Certified in Allergy/Immunology and Pediatrics. He is also a Certified Physician Investigator (CPI) and is a "hands on" Investigator (Click here for more information).

Dr. Karen Dunn is the Assistant Medical Director at NCCR and has served as either the PI or Sub-Investigator since 1988. Dr. Dunn is Board Certified in Allergy/ Immunology and Pediatrics and is also a Certified Physician Investigator (CPI).

Patti Becherer has been the Clinical Research Manager at NCCR since 1989. She has a B.S. in Nursing and is a Certified Clinical Research Coordinator (CCRC). Ms. Becherer has been involved in Clinical Research since 1986. As Site Manager she is responsible for overseeing all aspects of clinical trials at NCCR.

Our Clinical Research Coordinators (CRC) are the key to the success of a study. The CRCs are responsible for the day-to-day progress of each study. Our CRCs are all trained professionals with a variety of medical and research backgrounds, including RNs, LPNs, Medical Assistants, EMT, Paramedics, CCRCs, etc. Together our 11 coordinators have an average of 12 years of experience in Clinical Research. Their qualifications include but are not limited to:

  • Annual GCP Training
  • CPR Certified
  • OSHA Compliant
  • NIH-Certified “Protecting Human Research Participants”
  • IATA Certified
  • Experienced with several EDC, IVRS and E-Diary systems
  • Trained in ECG procedures, Phlebotomy, Spirometry, ENO Testing, Allergy Skin Testing

Jan Pochis has served as our Regulatory Administrator since 1997. Jan is responsible for all aspects of the regulatory filing and reporting in connection with our studies. Jan communicates with the IRBs and sponsors to assist in a smooth and timely turnaround of all regulatory documents.

Teresa Johnson is the Patient Recruiter at NCCR. As recruiter Teresa’s primary focus includes recruiting new patients to participate in clinical trials as well as matching previous patients with studies that meet both study and patient needs. Teresa has 16 years of experience in clinical research. Prior to her current position as recruiter she was Certified Clinical Research Coordinator at NCCR for 10 years.

Investigators/Sub-Investigators:

Margaret Doherty, PA-C is the Physician Assistant with Certification since 2002. Ms. Doherty has served as a Sub-Investigator for NCCR since 2008. Prior to her current position she was the Assistant Clinical Research Manager for NCCR for 4 years, and a Clinical Research Coordinator for 3 years.

Dr. Alan Aarons is Board Certified in Allergy/Immunology. He has been involved in clinical research studies since 1995. Dr. Aarons has served as both a Principal Investigator and a Sub-Investigator in studies with NCCR.

Dr. Vincent Firrincieli is Board Certified in Allergy / Immunology. He has been in private practice and has served as a Sub-Investigator in clinical research studies since 2003.

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