Clinical Research Center, now MDS Pharma Services - New Orleans, Louisiana, is a dedicated clinical research facility that has been in business for over 35 years. Founded in 1968 by Dr, F. Gilbert McMahon, our site continues to thrive as a dedicated Phase I-IV clinical research facility for investigating drugs, biologics, and devices. We have successfully completed over 1,300 clinical trials for nearly every major pharmaceutical company, as well as the FDA and NIH. The facility includes an inpatient unit with 100 beds and an outpatient clinic.

The site has two full-time, board-certified physicians with academic credentials and clinical trial experience that serve as principal investigators. Both physicians are highly experienced investigators and are Board Certified in Clinical Pharmacology. Combined, our dedicated core medical staff has over 80 years of clinical experience. Our Phase I unit is one of the oldest in the south and is know throughout the pharmaceutical industry for successfully completing complex special population clinical trials.

Over the years, our site has established a large patient database, which is routinely updated to provide accelerated recruitment and enrollment into trials. We also maintain close affiliations with Tulane University School of Medicine and LSU Medical School, where patient source and logistical support are readily available. Both of our primary investigators hold prestigious appointments in the departments of Medicine and Pharmacology at Tulane School of Medicine.

Our mission is to help sponsors meet their goals with the highest standards in operational efficiency, reliable data, and medical and ethical considerations.

Company Overview

MDS Pharma Services, a leading provider of innovative drug discovery and development solutions, acquired Clinical Research Center in June 2003. The acquisition establishes MDS Pharma Services as the largest clinical research provider in the industry with more than 900 beds. MDS Pharma Services now operates four early stage clinical research facilities in the United States, which is an additional benefit for current and future sponsors of Clinical Research Center.

MDS Pharma Services is part of MDS Inc., an international health and life sciences company. The company is focused on enhancing the health of people around the world. MDS Inc. provides laboratory testing, imaging products, and research services to speed discovery and development of new drugs. Furthermore, MDS offers therapy systems for planning and delivery of cancer treatments, analytical instruments to assist in the development of new drugs, and medical/surgical supplies.

Our site focuses on conducting ethical clinical trials encompassing Phase I-IV. With over 35 years of experience, we have conducted over 1,300 successful drug studies. Our therapeutic specialties include clinical pharmacology, endocrinology, metabolism, geriatrics, immunology/allergies/internal medicine, pulmonology, rheumatology/arthritis. Phase I experiences include first time in man safety/tolerance, PK/PD, pyrogen studies, isotope, BA/BE, liver impairment, radiolabel, renal impairment, drug-drug interaction, food effect, dental pain model, single and multiple dose tolerance, young and elderly, healthy and diseased.

Pharmaceutical sponsors we have worked with include: Abbott, Access, Advancis, AHP, Alza, Amgen, Astra-Zeneca, Aventis, Bayer, Berlex, Boehringer-Ingelheim, Bristol-Meyers Squibb, DuPont, Eisai, Endo, GlaxoSmithKline, Forest, Janssen, Knoll, Lilly, Lineberry, McNeil, Mead Johnson, Merck, Mylan, Novartis, Parke-Davis, Pfizer, Pharmacia-Upjohn, Pozen, Proctor & Gamble, R.W. Johnson, Roche, Sankyo, Schering-Plough, Searle, Sepracor, TAP, Triangle, and Wyeth.

CRO/SMO sponsors we have worked with include: ARC, Covance, Kendle, MDS, Paragon, Parexel, PPD, PRA, Quintiles, Clintrials, PharmaNet, JMG Clinical Research Inc. and Ingenix International.

Governmental agencies we have worked with include: FDA and NIH.

Our state-of-the-art facility has over 16,000 square feet, which includes 100 beds, semi-private volunteer rooms, outpatient clinic, monitor rooms, television room, special procedure rooms, dining facility, metabolic kitchen, visiting area, entertainment room with pool table/video games, family room, secured access, and pharmacy.

Various equipment available includes: right pear flow meters, infusion pumps, pH meters, platelet aggregometers, analytical balance, telemetry monitor, laminar hood, treadmills, full GI labs, datascope vital sign, bone density scans, holter monitors, ergometer, crash cart, refrigerated centrifuges, spirometer with computer printout, -80&degC and -20&degC freezers.

Robert Joseph Noveck, MD, PhD, FACEP, FCP
Executive Director

Dr. Noveck has been affiliated with our site since 1979. Certified in Clinical Pharmacology, he is an Adjunct Associate Professor in the Department of Pharmacology at Tulane University School of Medicine, and Associate Professor of Clinical Pharmacy and Pharmacology at Xavier University’s College of Pharmacy. As Assistant Director of Medical Research for Bristol Laboratories, Dr. Noveck was involved in clinical CNS analgesic programs and the NDA submission of the mixed opiate agonist-antagonist butorphanol tartrate (Stadol). He has served as principal investigator or sub-investigator of more than 200 trials involving pharmacokinetics/pharmacodynamics, drug-drug interaction, and mechanism of action trials. Dr. Noveck is certified by the American Boards of Clinical Pharmacology/Forensic Examiners and Emergency Medicine, as well as an Instructor in Advanced Cardiac Life Support.

Ramon Vargas, MD, MPH
Medical Director

As our site’s Medical Director, Dr. Vargas is certified in Clinical Pharmacology and serves as Clinical Assistant Professor of Medicine at Tulane University School of Medicine. Prior to his position at our site, he was Physician Coordinator in Clinical Research for Latin America with Smith Kline & French Laboratories and served as Deputy Director for Clinical Pharmacology Research with Syntex Laboratories, both in Mexico City. Dr. Vargas has also served as Associate Professor of Biostatistics at Tulane University School of Public Health and Tropical Medicine, Assistant Professor of Endocrinology at Universidad Nacional Autonoma de Mexico, and Visiting Physician with the Experimental Medicine Service, Unidad de Medicina Biopsicosocial, Hospital General de Mexico. Dr. Vargas is a member of ASCPT and he is a Fellow of the College of Clinical Pharmacology.

Betty Moore
Bids & Contracts

Sandra Gotzkowsky, RN, CCRC
Clinical Operations Manager

Jeanne Delbert
Quality Control

Melissa Kelton
Recruiting Manager

Robert Vaccaro, Jr.
Marketing Coordinator

Glenda Middlebrooks
IRB & Records Management

Louis O. Lenfant Jr., RPh
Pharmacist

Emanuel D’Angelo Jr., RN BSN, CCRC
Nursing Services, Inpatient Unit

Study Coordinators (6)

Study Technicians (7)

Special population includes subjects that are healthy, elderly, hypertension, pre and post-menopausal, hypercholesterolmia, renal insufficiency, cirrhosis (Childs-Pugh A, B & C), asthma and seasonal allergic rhinitis, diabetes and cardiovascular disease. Our site has an established database developed for subject/patient listing which is constantly updated and replenished. We use multi-media advertising through television, radio and local newspapers. We also sponsor various community outreach programs and have established a referral system with local medical facilities and institutions.

• Our IRB meets twice monthly and is available for special meeting as necessary. We have also worked with several central IRBs.
• Own pharmacy and full-time pharmacist.
• QC/QA audit by full-time internal staff.
• SOPs for all procedures on file.

For more information, please contact:

Sandra G. Gotzkowsky, RN, CCRC
Clinical Operations Manager
Clinical Research Center (MDS Pharma Services)
2237 Poydras Street
New Orleans, LA 70119 USA
Phone: 504-826-5000
Fax: 504-826-5088
E-mail:

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

Name:
Address:
City:
State:
Zip:
Phone:
Email address:
Message:

Please note: A number of commercial online services display an error message after you click on Send. Please be assured that your message has been received.

Last updated on October 8, 2008