Staff
NCRI staff includes 7 CRCs, 2 regulatory professionals, as well as support and management professionals. Five of these are ACRP certified and all CRCs are either certified or on track to certification. The current Director, Bob Romanchuk holds certification as CCRC, CHRC (Certified in Health Research Compliance), CIP (Certified IRB Professional) and CRCP (Clinical Research Contract Professional) with 30 years of clinical experience as a Registered Respiratory Therapist.
Regulatory
The IRB of record for NCRI is Forsyth Medical Center IRB. This IRB meets monthly (first Thursday) with a submission deadline of 10 days prior and approval time of 5 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's Fair Market Value in Clinical Research Pricing policy to assure equitable pricing in compliance with AKS and Stark rules. A robust process of tracing clinical trial billing and coding assures 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
- Arrhythmia
- DVT/PE treatment and prophylaxis
- Infectious disease including
- CAP, HAP
- HIV
- Bacteremia
- Influenza
- CSSI
- 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
The director, Bob Romanchuk facilitates negotiation of contracts and budgets and has signatory authority. A turnaround of two weeks is typical. Forward contracts to:
Director: Robert Romanchuk, BS, CIP, CCRC, CHRC
Novant Clinical Research Institute
1405 South Broad Street
Winston-Salem, NC 27127
Phone: 336-277-0932
Fax: 336-277-9153
Email: rhromanchuk@novanthealth.org
