Northeast Clinical Research Center, LLC.

Center Information

Stephanie Hanzl, RN, CCRP
Research Manager
Northeast Clinical Research Center, LLC.
2014 City Line Rd.
Suite 103
Bethlehem, PA 18017
USA
610-433-4100
610-433-1919 (fax)
steph.hanzl@necresearch.org
www.necresearch.org
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Currently Enrolling Trials

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Therapeutic Areas

Nephrology

Center Overview

Northeast Clinical Research Center is a dedicated medical research institution. We are a division of Valley Kidney Specialists, PC, a large private Nephrology practice in the Lehigh Valley. The practice has 21 physicians, 3 certified Registered Nurse Practitioners, 3 Physician Assistants and a research staff of 6 which include two full-time study coordinators.

Performance Metrics

Number of Studies Conducted: 500+
Number of Studies Actually Completed: 500+
Number of Active Patients in the Database: 75
Regulatory Submission Turn-Around Time: 30 Business Day(s)
Average Percent of Total Patients Randomized: 90%
Average Percent of ‘Completed’ Studies that met Enrollment Goals: 80%
EDC Capabilities: Yes

Staff Certifications
Number of Certified CRCs: 2
Number of Certified PIs: 1

ACRP Certifications

Clinical Research Experience

While we have a variety of interests, we currently focus on research related to kidney disease, hypertension, and care of dialysis patients. We are currently performing a variety of research studies involving the treatment of diabetes in patients with kidney disease and methods to delay the need for dialysis in patients with kidney failure.

Our experience has been in phase 2, 3, and 4 studies. In almost every study, we have been able to enroll the number of evaluable patients that the sponsor required. Most of the study participants come from our private practice.

A list of sponsor's we have worked with include:

  • Abbott/Abbvie
  • Boerhinger-Ingelheim
  • Bristol Myers Squibb
  • GlaxoSmithKline
  • Lilly
  • Merck
  • Novo Nordisk
  • Novartis
  • Pfizer
  • Roche
  • Luitpold
  • Amgen
  • Otsuka
  • AstraZeneca
  • Celgene
  • KAI Pharmaceuticals
  • Questcor Pharmaceuticals

Facility Description

Many of our patients have multiple medical problems and have several physicians involved in their care. We try to make our appointments as convenient as possible. Our site is located in Bethlehem, PA which may be closer to home and offer more convenient parking. Our site is easily accessible by car and public transportation. We also have access to see patients at the practices' main office located on the campus of Lehigh Valley Hospital – Cedar Crest.

Our facility has an infusion room equipped with a hospital bed, TV/DVD player to provide patients privacy and comfort during long visits.

Investigator Experience

Dr. Nelson Kopyt, DO graduated from the University of Pennsylvania and the Philadelphia College of Osteopathic Medicine. He completed his Internal Medicine Residency and two year Fellowship in Nephrology at Temple University Hospital in Philadelphia. Dr. Kopyt was named one of the 'Top Doctors' by US News and World Reports in 2012. He is the Medical Director of the East Stroudsburg dialysis unit. Dr. Kopyt is also a Fellow of the American College of Physicians. He is certified by the American Board of Internal Medicine in Nephrology and Internal Medicine. He is also certified in Clinical Hypertension by the American Society of Hypertension. Lastly, Dr. Kopyt is a Certified Principal Investigator and has been doing research for almost 30 years.

Staff Expertise

Stephanie Hanzl, RN, CCRP
Research Manager
10 years experience

Jenna Camacho, NCMA, CCRP
8 years experience

Leda Babian, MA
2 years experience

Pam Culver, MA
2 years experience

Patient Demographics

Valley Kidney Specialists, PC has grown to be the largest Nephrology practice in the region. We have a close professional relationship with our patients.

Other Information

Our site primarily uses central IRBs. We do have the option of using a local IRB if necessary. Dr.Kopyt is personally involved in every aspect of the study process with the study coordinators. Our coordinators are consistently recognized for their "clean" documentation.

Contact Center

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the email form below. A representative from the research center will then follow up with you.