Clinical Trial Resource Center

Therapeutic Areas

Devices
Family Medicine
Genetic Disease
Healthy Volunteers
Hepatology (Liver, Pancreatic, Gall Bladder)
Infections and Infectious Diseases
Internal Medicine
Nutrition and Weight Loss
Orthopedics/Orthopedic Surgery
Plastic Surgery
Podiatry
Sleep
Urology
Vaccines

Center Overview

Wake Research Associates, established in 1984, is a nationally recognized professional research organization specializing in conducting pharmaceuticals, device and nutrition trials. Wake Research Associates is an independent research center based on an 18 physicians’ multi-specialty private practice drawing from a current patient population of approximately 80,000. We are affiliated with two major hospitals within close proximity: Wake Medical and Rex Hospital. WRA is also affiliated with 27 subspecialty physicians in the Raleigh area. WRA’s association with Key IPA and its 140 physicians allows a greater outreach to our community. Our on site sleep lab, Wake Sleep Center has 12 patient beds and certified polysomnographic technicians.

We have over 20 years of clinical research experience. As of 2007, our board certified physicians have completed more than 2200 successful clinical trials. Clinical trials at our site are always completed on time and with accuracy; we consistently exceed sponsor expectation for integrity, subject enrollment, human protection and expeditious delivery of accurate evaluable data.

Wake Research Associates is a unique and innovative resource for Phase I-IV clinical trials. Our site is known for effectively combining strategic patient recruitment and retention with high quality clinical research procedures. Our approach is uncompromising - each study conducted at our site is carefully planned and executed according to regulations with superior quality.

Clinical Research Experience

Our focus is on Phase I-IV research trials and pharmokinetics studies. As of 2007, Wake Research has successfully conducted more than 2,200 clinical trials.

We conduct our clinical trials to ensure timely completion as well as high-quality and accurate work. We continually exceed sponsor expectations of integrity, subject enrollment goals, and human protection in addition to expeditious delivery of accurate evaluable data. Wake Research consistency monitors its team and work performance seeking room for improvement and growth. Our goals include team collaboration to improve the care of our patients and aid in the rapid availability of new, cutting-edge treatments to our patients and the community.

Our therapeutic specialties include:

• Internal Medicine
• Gastroenterology
• Pulmonology/Immunology
• Cardiology
• Infectious Diseases
• Gynecology/Women's Health
• Rheumatology
• Urology
• Psychiatry
• Neurology
• Provocative Meal Studies
• Pain Management
• Medical Devices
• Rx to OTC Studies
• Dermatology
• Weight Management/Nutrition

We have conducted/are currently conducting studies for the following conditions:

We have worked with the following sponsors:

Glaxo-Wellcome, Bristol Myers, Genetics Institute, G.D. Searle Pharmaceutical, Otsuka Pharmaceutical, Tap Pharmaceutical, Kabi Pharmaceutical, RW Johnson, BioCryst, Merck, Janssen Pharmaceutical, Wyeth Pharmaceuticals, Ciba Geigy, Eli Lilly, Upjohn, Schering Plough, Hoffman-LaRoche, Gilead, Bayer, Boehringer Ingelheim, KOS Pharmaceuticals, Parke-Davis Pharmaceuticals, Smith-Kline Beecham, Takeda America, Abbott Pharmaceutical, Pfizer, Novartis, Targacept, ALZA, Purdue Pharma, McNeil, Allergan, Pain Therapeutics, Sanofi-Synthelabo, Axcan, AstraZeneca, Centocor, Neurocrine Biosciences, Pharmacia, Berlex, Barr Research, Inspire, Santarus, Elan, Celgene, Celltech, Acambis, Braintree, Baxter, Novum, Arena Pharmaceuticals, Hisamitsu, BioSante, Apotex, Galderma, Strakan, Luitpold, Repros, Regeneron, Horizon Therapeutics, MedPointe, Orexigen, NiCox, Dow Pharmaceuticals, DuraMed Research, Cypress Bioscience, Nastech, Salix, Basilea Pharmaceutica, Pozen, Plethora, Amylin, Hutchinson, Vivus, Xenoport, Zars, Symbollon, Jazz, Shionogi, Glenmark, Organon, Schwarz, Astellas, AMAG, Celtic, Furiex, Chesson, Forest, Eisai, Merz, Synergy, Danone, Falk, Paion, Perrigo, Palatin, Logical, Romark, Cephalon, Dynport, Tranzyme, Baxter and Watson.

CRO's:

ClinTrials, Quintiles, PPD-Pharmaco, Kendle, Kern McNeil, Premier Research, Scirex, IBRD, IBAH, Phoenix, Inc., InSite Clinical Trials, Bio Pharmaceutical, Parexel, Paragon, ICON, PRA, Dertech, TKL, AAI, Medpace, Kendall, Iveresk, Parexel, Integrium, Criterium, Essential, CompleWare, Omnicare, Metropolitian Research Associates, MedSource, Encorium, Premier, United Biosource, Covance, Pharm-Olam, Advanced Biologics, CTMS, Charles River, PharmaLink, Pharmanet i3 Research, Novella and Beardsworth.

IVRS & EDC Systems:

Oracle, Data Track, IcoPhone, Study Works, RAVE, eClinical, Medidata, Inform, Remote Data Capture, Impala IVRS, Phoenix Data Sytems, eTrials, ClinPhone, Covance, RAMOS, SBIR, Maaguzi, Omnicomm Trialmaster, Clarix and Phase Forward.

Facility Description

Wake Research Associates is focused on the needs of both patient welfare and the growth of pharmaceutical research and development.

Our site facilities include:

• Secured Investigational Drug Storage
• Certified Endoscopy Unit with 5 suites and recovery
• Certified Diagnostic Laboratory
• X-Ray Department with Bone Densitometer and Ultrasound Unit (3) and
• Certified Mammography Unit
• Nuclear Medicine, heart station, EKG, treadmills, Holter Monitor, echo ECG
• Complete Pulmonary Unit with Spirometry, Peak Flow Monitoring & Survey System Plus
• Phase I and Pharmocokinetic Unit with infusion capabilities, private rooms, shower and TV
• Facilities for Provocative Meal Studies

Wake Research Associates is conveniently located 15 minutes from an international airport, minutes from major hotels, restaurants and shops as well as one of Raleigh's largest hospitals, Rex Hospital which is located just 0.5 miles from our site.

Investigator Experience

Our primary investigators are:

Charles Barish, MD
Area of expertise: Gastroenterology

Jonathan Flescher, MD
Area of expertise: Pulmonology , Sleep Medicine, Men’s Health and Smoking Cessation

Wayne Harper, MD
Area of expertise: Internal Medicine, Metabolic Disease and Vaccines Trials

Susan Eder, MD
Area of expertise: Psychiatry

Adnan Nasir, MD, PhD
Area of expertise: Dermatology

Pouru Bhiwandi, MD
Area of expertise: Gynecology and Women's Health

Singar Jagadeesan, MD
Area of expertise: Neurology and Sleep Medicine

Arvind N. Jariwala, MD
Area of expertise: Geriatrics and Internal Medicine

Christopher McDaniels, MD
Area of expertise: Pediatrics

Our sub-investigators are:

Daniel Mollin, MD
Area of expertise: Internal Medicine

Bulent Ender, MD
Area of expertise: Gastroenterology

Treva Tyson, MD
Area of expertise: Women's Health and Internal Medicine

Ella Grach, MD
Area of expertise: Pharmacoviligance

Curtis Carlson, MD
Area of expertise: Internal Medicine

Seth A. Kaplan, MD
Area of expertise: Gastroenterology

Miroslav Gavazov, MD
Area of expertise: Internal Medicine

Jerome B. Gardner, MD
Area of expertise: Women’s Health

Marc A. Herschelman, DO
Area of expertise: Gastroenterology

MaryAnn Pollock, PhD
Area of expertise: Nutrition

Debrah Barish, MS
Area of expertise: Nutrition

David Colvard, MD
Area of expertise: Psychiatry

Tamara Housman, MD
Area of expertise: Dermatology and Cosmetics

Richard Kurzman, MD
Area of expertise: Women's Health

Rildia Pritchett, MD
Area of expertise: Women's Health

Wanda Radford, MD
Area of expertise: Women's Health

Staff Expertise

Research employees of Wake Research Associates include a variety of health professionals such as registered nurses, LPN, CMA and registered dieticians, all who assist investigators in conducting all phases of clinical trials. Our clinical staff members are certified in blood pressure monitoring, CPR, advanced cardiac life support, ECG, phlebotomy and bone density scans.

Wake Research Associates has 16 full-time coordinators, including 4 RN, 2 LPN, 1 CMA and 1 MA, Quality Assurance, 2 Regulatory Specialists, and 3 dedicated patient recruiters. Four coordinators are certified by ACPR.

Patient Demographics

Wake Research Associates draws from a subject population of over one million. Our current database includes over 80,000 patients. Our patient volunteer database is constantly expanding and provides our Sponsors with more homogeneous research groups and thus, stronger clinical research trials. Wake Research Associates prides itself in rapid recruitment, consistently being a top enroller in majority of clinical trials.