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Research Center Profile:
OtriMed Clinical Research

Center Information

Dr. Pragya B. Gupta, M.D., F.R.C.S (Edin), D.A.B.P.M.
Physician Investigator; Board Certified Pain Management Specialist
OtriMed Clinical Research
Advanced Pain Treatment Center
Edgewood, KY 41017
USA
859.757.1359
859.331.6600 (fax)
pshay@otrimed.com
www.otrimed.com
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Therapeutic Areas

Musculoskeletal
Neurology
Psychiatry/Psychology
Sleep

Center Overview

OtriMed is an independent research site dedicated to conducting high quality clinical trials focused on pain management, achieved through ensuring patient safety and the execution of quality research by our experienced staff. Our integrity, well organized project management and detailed data collection, complemented by our dedication to recruitment and retention ensures expected timelines are met or exceeded. We are currently equipped to conduct Phase II-IV clinical trials.

Facility Description

OtriMed is located in Northern Kentucky in close proximity to St. Elizabeth Medical Center and is adjacent to Advanced Pain Treatment Center, at 162 Barnwood Drive, Edgewood, KY 41017, and approximately 10 minutes (8 miles) from Cincinnati-Northern Kentucky International Airport.

OtriMed is a dedicated research facility offering:

  • Dedicated and secure space for research staff
  • Dedicated research exam rooms
  • Access to database of 2500+ patients through affiliation with the Advanced Pain Treatment Center
  • Current patient population: wide range of chronic, benign and cancer pain
  • Private space for conducting the Informed Consent Process
  • Limited access drug storage area, also meeting the requirements of storing controlled substances
  • Access to a local hospital
  • Laboratory processing area, refrigerated centrifuge, -20° freezer, lockable refrigerator
  • Fully monitored recovery area
  • Wireless internet
  • Standard Operating Procedures
  • IATA certified staff for lab shipment
  • Private space for monitors and auditors
  • ACLS Certified Staff
  • Physician availability 24 hours
  • Access to copiers, fax machines and telephones
  • Ample parking
  • Pre-Paid Debit Cards for Subject Stipends

Investigator Experience

PRAGYA B. GUPTA, M.D., F.R.C.S. (EDIN) D.A.B.P.M.

Founder and Medical Director of OtriMed and Medical Director of Advanced Pain Treatment Center in Edgewood, Kentucky and Mason, Ohio; Dr. Gupta has successfully treated more than 2500 patients and is excited to be able to offer them cutting edge therapies by offering access to clinical trials.

Diplomate of American Board of Pain Medicine, initial certification in 2000 & recertified in 2011.
Diplomate of American Board of Anesthesiology (1999)
American Board of Anesthesiology Subspecialty Certification in Pain Medicine initial certification in 2000 & recertified in 2011.
Fellow of the Royal College of Surgeons of Edinburgh (FRCSEd) – General Surgery,, United Kingdom (1989 - 1993) – certified in 1993.
Fellowship trained Pain Management Specialist - Tufts University School of Medicine – New England Medical Center, Boston, MA (1998 - 1999).
University of Illinois – Metro group, Residency in General Surgery , 1994 -1995
Residency Training in Anesthesiology - Tufts University School of Medicine – New England Medical 1995 – 1998

Clinical Research Experience

Principal Investigator A Product Surveillance Trial sponsored by XXXXXXX- A non-randomized active prospective post-marketsurveillance trial to determine the continuing evaluation and periodic reporting of safety andeffectiveness of market-released products for their intended use.

Principal Investigator XXX-XXXX A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY) in Opioid-experienced Subjects with Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation who Require Around-the-clock Opioid Therapy.

Sub-Investigator XXX-XXX Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of XXX-XXX in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Inadequate Response to Prospective Treatment With an Antidepressant.

Sub-Investigator XXX-XXX A Phase 3, Open-label, Multicenter, 12-month Extension Safety and Tolerability Study of XXX-XXX in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Residual Symptoms or Inadequate Response Following Treatment With an Antidepressant

Joseph Kline, PhD, MD, MBA

Dr. Joseph Kline is a board certified Psychiatrist that joined OtriMed as a Principal Investigator and Sub-Investigator. Dr. Kline obtained is doctorate in Physiology and Biophysics from the University of Louisville in 1983 before he received his medical degree from the University of Louisville School of Medicine in 1986. Dr. Kline is the Medical Director of his private practice located in Florence, KY. Dr. Kline has served a Principal Investigator for several Industry Sponsored Clinical Trials in the areas of Treatment Resistant Depression, Major Depressive Disorder, Depression with pain, Schizophrenia, Migraine Headaches, and Alcohol Cessation. He has also served as a Sub-Investigator for several research trials.

Staff Expertise

Patricia Shay, CCRC, Certified Clinical Research Coordinator

Patricia is a certified clinical research coordinator with over 13 years of clinical research experience. She started as a clinical trainer for Phase I trials and went on to coordinate Phase II & III clinical trials. Patricia also spent 5 years at the University of Cincinnati coordinating grants funded by the National Institute of Health and the National Institute of Alcohol Abuse and Alcoholism. Ms. Shay is a member of the Association of Clinical Research Professionals and has been certified through the academy for over 6 years. Ms. Shay has worked in several different areas of research including Sleep Disorders, Alcohol Dependence, Smoking Cessation, Fibromyalgia, Migraine, Depression and other psychiatric disorders, Type II Diabetes, and Cardiovascular Risk trials. Ms. Shay is a trained phlebotomist and ECG technician; she has worked with a variety of electronic data capture systems.

As part of her position as a Clinical Research Coordinator, Ms. Shay also has experience in regulatory affairs and is well trained in Good Clinical Practices and ICH Guidelines. In her career, she has written SOPs and implemented training programs for new hires.

Ryan W. Sims, Research Assistant

Ryan joined OtriMed in 2013 as a Research Assistant. His primary functions are subject recruitment, data entry and to serve as a back-up, to the Study Coordinator.

Ryan has a military and law enforcement background, and has most recently served as a Combat Engineer, with the United States Army. Ryan possesses strong interviewing and computer skills. He is certified in Good Clinical Practices, has attended basic CLS (Combat Life Saver) training, and is familiar with a variety of Electronic Data Entry Systems.

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