Sponsor A Trial With Pulmonary Associates

We appreciate the opportunities we have had to partner with the many sponsors and CROs that we have worked with to date, and welcome discussions regarding our capabilities and experience as they relate to potential new studies. Our mission is to conduct clinical trials successfully with exacting standards in order to build longstanding relationships with our customers. We look forward to hearing from you.

About The Center

Mark H. Gotfried, M.D.

MEDICAL DIRECTOR

PACT / Pulmonary Associates, PA / Arizona / Clinical Research / Pulmonology and Sleep

1112 E. McDowell Road
Phoenix, AZ 85006

602-346-4747
602-258-1113 (fax)
m.gotfried@pulmonaryassociates.com

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Studies Conducted

Studies Completed

%

Of Patients Randomized

%

Of Studies Met Enrollment Goals

PACT’s founding physicians have been conducting clinical research for over 25 years, and our research group has grown to include two investigative sites and four sleep labs. As we continue to provide excellent service in our legacy areas of pulmonary trials, sleep disorders and pharmacokinetic studies, our capabilities have also grown to include several other therapeutic areas. Our research group has experience in cardiovascular studies including hypertension and hyperlipidemia; metabolic disorders such as diabetes, and gastrointestinal disorders. Our independent research group has established relationships with physicians in additional disciplines that can help identify patients for our studies.

Under the direction of Dr. Mark Gotfried, a Certified Principal Investigator and Dr. Bernard Levine, PACT investigators have conducted over 400 studies with at least 100 sponsors and more than 15 CROs in all phases of clinical research. Experience such as this, combined with the excellence of our 5 full-time study coordinators, a full-time pulmonary function technician, and a regulatory document specialist enable us to provide sponsors with a research staff that is able to anticipate enrollment challenges and address the situation before precious time is wasted, helping to keep sponsors’ budgets and timelines on track.

At PACT, we are always focusing on how we can be sure that our site is at the top of the list when sponsors are recruiting investigative sites. We assess our resources, staff, equipment and research space regularly to make sure we are doing everything possible to make PACT a “go to” site for sponsors and CROs. We are pleased to have many sponsors who return to our research site time and again to get the same quality that they have come to know and expect from our site.

As a leading site in the area of pulmonary research, PACT has expertise in asthma, COPD, pulmonary fibrosis, pulmonary hypertension and many other pulmonary/respiratory diseases. PACT is known for its role in obtaining pharmacokinetic and pharmacodynamic data for antibiotics and other compounds in development. We have an extensive database, which allows us to successfully enroll patients into our research studies, and our familiarity with these areas helps us to avoid potential pitfalls that others might have, as evidenced by our usual low screen failure rates.

Our research group also manages 4 sleep labs (14 total beds) in the Phoenix area, and our sleep research staff includes 4 certified polysomnographer physicians along with 12 polysomnograph technicians. We have conducted sleep disorder studies in such areas as: insomnia, OSA, narcolepsy, non-restorative sleep, excessive sleepiness, SWSD and RLS. We have technicians available 24/7 and provide priority scheduling to our sleep research patients in order to help sponsors meet their timelines.

Besides these 2 key areas of our research expertise, we have done studies in areas such as: CV, GI, Hematology, Metabolic/Endocrine, Immunology/Infectious Disease, Musculoskeletal, Urology, PK/PD, and Device studies.

Besides our affiliation with the 14 pulmonologists on staff, our research is supported by 10 internists, 3 endocrinologists, and 5 surgeons. We also have relationships with registered dieticians with whom we have worked on earlier clinical studies.

Investigator Experience

Mark Gotfried, MD - Medical Director/Principal Investigator

Dr. Gotfried received his degree in medicine with honors from the University of Illinois. He completed his internship and residency both at Michael Reese Hospital in Chicago followed by his pulmonary fellowship at the University of Arizona in Tucson. Dr. Gotfried joined Pulmonary Associates in 1983 and is board certified in Internal Medicine, Pulmonary Disease and Sleep Disorders Medicine. Dr. Gotfried has over 20 years of clinical research experience in a variety of therapeutic areas. In addition to his practice and research work, Dr. Gotfried is a Clinical Professor of Medicine at the University of Arizona and an Adjunct Professor of Pharmacy Practice at the University of Illinois. Dr. Gotfried is a Certified Principal Investigator. He has served as a consultant in numerous advisory boards regarding clinical trials.

David Baratz, MD - Principal Investigator

Dr. Baratz received his MD from the University of Arizona College of Medicine. He is board-certified in Internal Medicine, Pulmonary Medicine and Sleep Medicine. He has been conducting clinical research for over 5 years and his research specialties include: sleep disorders, COPD, Asthma, and Pulmonary Arterial Hypertension.

J. Burr Ross, MD - Principal Investigator

Dr. Ross attended the University of Nebraska, where he received his MD degree. He is board-certified in both Internal Medicine and Pulmonary Disease. His research experience includes extensive work in invasive Bronchoscopic technique for emphysema and cancer diagnosis.

Clinical Research Experience

Pulmonary/Respiratory

ABECB, asthma, bronchiectasis, CAP, chronic bronchitis, COPD, diabetes/asthma, diabetes/COPD, diabetes – PFT, emphysema, exacerbation/COPD, fibrosis, IPF, influenza, invasive fungal infection, lung Bx, nosocomial pneumonia, pulmonary hypertension, pulmonary function tests, pulmonary nodules, respiratory tract pathogen, serious CAP, serious COPD, ventilator associated tracheobronchitis, ventilator associated pneumonia

Sleep Disorders

Insomnia (elderly), insomnia, excessive sleepiness, ICU sedation, narcolepsy, non-restorative sleep, OSA, OSA & depression, RLS, SWSD

Pharmacokinetic/Pharmacodynamic

Normal bronchoscopy, normal subjects, tissue drug levels

Device

Emphysema device

Healthy Volunteer - Phase 1

Additional Information

  • Cardio Pulmonary Exercise (CPX) Unit
  • 2 Body Box (Body Plethysmography)
  • Pulmonary Function Lab
  • 4 Sleep Labs (14 beds)
  • 4 Clinic beds for Overnight Visits
  • Onsite X-Ray equipment
  • -20°C Freezer
  • -70° Freezer
  • PK Sample Storage
  • Locked, secured and monitored Drug Storage
  • ECG machines
  • Refrigerated / Ambient Centrifuges
  • Full radiology affiliation
  • Compounding Negative Pressure Pharmacy Hood
  • Experience with Central Laboratories
  • IV Pumps
  • 5 full-time study coordinators
  • 1 pulmonary function technician
  • 1 regulatory document specialist
  • 14 pulmonologists
  • 4 polysomnographers
  • 10 internists
  • 3 endocrinologists
  • 5 surgeons
  • 2 dietitians
  • CARDIOLOGY/VASCULAR DISEASES
  • DEVICES
  • ENDOCRINOLOGY
  • GASTROENTEROLOGY
  • HEMATOLOGY
  • IMMUNOLOGY
  • INFECTIONS AND INFECTIOUS DISEASES
  • NEUROLOGY
  • PULMONARY/ RESPIRATORY DISEASES
  • SLEEP
  • PUROLOGY
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