Forsyth Medical Center Go

Sponsors

Novant Health Clinical Research was established in 2001 and has grown from a staff of four, with a focus on cardiovascular studies, to a staff of 14, who conduct and manage trials in a wide range of therapeutic indications.

Staff

The Novant Health Clinical Research staff includes seven clinical research coordinators (CRCs), two regulatory professionals, and support and management professionals. Five of these are Association of Clinical Research Professionals (ACRP)-certified and all CRCs are either certified or on track to certification. The current Director, Bob Romanchuk, holds certification as Certified Clinical Research Coordinator (CCRC), Certified in Health Research Compliance (CHRC), Certified IRB Professional (CIP), and Clinical Research Contract Professional (CRCP ) with 30 years of clinical experience as a Registered Respiratory Therapist.

Regulatory

The institutional review board (IRB) of record for NCRI is Novant Health Forsyth Medical Center IRB (FMC-IRB). This IRB meets monthly (first Thursday) with a submission deadline of 10 days prior and approval time of five days post for new studies. FMC-IRB will defer review to external IRBs on a case-by-case basis.

Contracts / Budgets

Contracts are negotiated directly with NCRI with a usual turnaround of one week. NCRI complies with Novant Health's Fair Market Value in Clinical Research Pricing policy to ensure equitable pricing in compliance with AKS and Stark rules. A robust process of tracing clinical trial billing and coding ensures compliance with CMS regulations governing billing for clinical trial participants.

Experience

NCRI's investigators have conducted over 200 phase II-IV drug and device studies in the following therapeutic areas:

  • Hyperlipidemia
  • Diabetes
  • Hypertension
  • IBS gout
  • Arrhythmia
  • DVT/PE treatment and prophylaxis
  • Infectious disease including:
    • CAP, HAP
    • HIV
    • Bacteremia
    • Influenza
    • CSSI
    • HCV
  • Stroke
  • Cardiac/vascular, including:
    • ACS
    • STEMI/NSTEMI
    • DES
    • PFO
    • Cardiac CT and IVUS
    • CHF
  • Carotid artery disease/occlusion
  • PAD
  • Long-term sedation
  • General surgery

Previous research sponsor-partners include: Amgen, Pfizer, Cubist, Canyon, Forest Labs, Sanofi-Aventis, Amplatzer, Abbott, Invatec, Merck, Possis, Roche, Idev, Takeda, Trivascular, Abiomed, Medtronic, GSK, Astra-Zeneca, Baxter, Bayer, Berlex, Atrium, CVRx, J J, GE Healthcare, Hospira, Lifecell, SJM, Eli Lilly, TriAciv, Volcano, Wyeth and others.

Previous CRO partners include: PPDI, Quintiles, Covance, Parexel, HCRI, DCRI, J Tyson, Global Research, Global Clinical Trial Operations, RCRI, Clinametrix, Weststat, Scimetrica, Symbios, TIMI, Paragon, MBS and other.

Contracts budgeting

Director Bob Romanchuk facilitates negotiation of contracts and budgets and has signatory authority. A turnaround of two weeks is typical. Forward contracts to:

Sr. Director: Robert Romanchuk, BS, CIP, CCRC, CHRC
Novant Health Clinical Research 
1900 S. Hawthorne Road, Suite 664
Winston-Salem, NC 27103
Phone: 336-277-0932
Fax: 336-277-9153
Email:
 rhromanchuk@novanthealth.org