Overview

Piedmont Ear, Nose, and Throat Associates offers a full range of ear, nose and throat services including sinus surgery, head and neck cancer surgery, treatment of balance and dizziness disorders, treatment of tinnitus, treatment of voice and swallowing disorders, allergy desensitization, facial plastic surgery, treatment of sleep disorders and snoring, and treatment of hearing loss with comprehensive hearing aid sales and service. At PENTA Research, our goal is to advance health care and provide novel therapies for our patients by conducting clinical trials.

Our Facilities

Our practice is located in the Piedmont Triad area which includes Winston-Salem, Greensboro and High Point and has access to an estimated population of 1,611,243. With 4 practice locations in Winston-Salem, Kernersville, Clemmons and Mount Airy, our practice has over 110,000 patients in our patient database. Our Winston-Salem office is located within 4 miles of two major hospitals in the Winston-Salem area, including a Level 1 regional trauma center.

Our Winston-Salem location is home to an allergy department specializing in allergy desensitization, and an audiology department with five licensed certified audiologists specializing in a full range of audiological services including comprehensive audiograms, tympanograms, otoacoustic emissions (OAE), VNG, and ECochG testing. Adjacent to our Winston-Salem office is Piedmont Outpatient Surgical Center, an ambulatory outpatient surgical center owned and operated by Piedmont Ear, Nose and Throat Associates, specifically designed to provide a comfortable, high quality and caring environment for patients requiring ENT or facial plastic surgery.

With a fully integrated clinical research site located within our Winston-Salem office, our facility has a dedicated clinical research office including: secure document storage, monitoring spaces, secure phone and fax lines, and high-speed internet access. We offer laboratory specimen collection and processing including: phlebotomy, centrifugation, access to dry ice, IATA compliant specimen shipping, temperature-controlled and monitored drug refrigerators and freezers, temperature-controlled and monitored specimen refrigerators and freezers, and a secure drug room. We also have on-site diagnostic technology including nasal endoscopy with video capabilities, EKG, and CT scans.

Investigators

Our practice is comprised of highly motivated clinical research investigators with decades of Principal Investigator and Sub-Investigator experience. Our 10 board certified physicians and physician assistant include:

• John C. Britt, MD – American Academy of Otolaryngology – Head & Neck Surgery
• S. Andrew Harper, MD – American Academy of Otolaryngology – Head & Neck Surgery
• J. Lucas Inman, MD – American Academy of Otolaryngology – Head & Neck Surgery
• Kenneth S. Maxwell, MD – American Academy of Otolaryngology – Head & Neck Surgery; Fellowship in Neuro-otology
• C. David Phipps, MD – American Academy of Otolaryngology – Head & Neck Surgery
• Stephen B. Potts, MD – American Academy of Otolaryngology – Head & Neck Surgery
• Kevin Shefferly, PA-C – American Academy of Physician Assistants
• W. Cooper Scurry, Jr., MD – American Academy of Otolaryngology – Head & Neck Surgery and the American Board of Facial Plastic & Reconstructive Surgery
• Gwendolyn F. Wagoner, MD – American Academy of Otolaryngology – Head & Neck Surgery
• John H. Willis, MD – American Academy of Otolaryngology – Head & Neck Surgery

Therapeutic Areas

We conduct Phase I- IV pharmaceutical drug and device trials in the areas of:

• Hearing loss
• Allergy and Asthma
• Cosmeceuticals
• Device studies
• General ENT studies
• Head and Neck Cancer
• Meniere’s Disease
• Nasal Polyps
• Nasal Wall Collapse
• Oral Cancer
• Otitis Externa
• Otitis Media
• Otomycosis
• Ototoxicity
• Rhinitis
• Sinusitis
• Sinus/Nasal Airway Obstruction
• Sleep Apnea
• Surgical ENT studies
• Tinnitus
• Tonsillitis
• Tympanostomy Tubes
• Vertigo

Clinical Research Staff

Our trials are conducted with strict adherence to Good Clinical Practice guidelines. We have three highly knowledgeable, full-time Clinical Research Coordinators on staff for efficient management of our clinical trials. Our coordinators are experienced in site initiation and Central IRB submissions for rapid submission of our contracts and regulatory documents. Our research staff is trained and certified in ICH guidelines for Good Clinical Practice and HIPAA regulations to protect patient confidentiality. Our staff is trained in the Columbia Suicide Severity Rating Scale, Placebo Mitigation, patient eDiary use, RTSM and IRT systems, phlebotomy, IATA standards for specimen shipping, and BLS/CPR certified. Our research coordinators place high priority on accurate source documentation practices, rapid recruitment to meet enrollment targets, and an average retention rate over 95% on our trials.

For information about our site’s feasibility, or more information about our enrolling trials, please contact the Clinical Research Department at (336) 768-3361 Opt# 6.

Contact our coordinators at:

Nuri Park, BS

Title: Clinical Research Coordinator
npark@piedmontent.com

Onyinyechi Ukaegbe MBBS, PhD, FWACS
Title: Clinical Research Lead
Email: oukaegbe@piedmontent.com

Elizabeth Dahl, BS, EP-C
Title: Clinical Research Coordinator
Email: edahl@piedmontent.com

Visit us at www.piedmontent.com for more information.

Has EDC Capabilities: Yes