Clinical Trial Resource Center


Clinical Trial Resource Center

Research Center Profile:
PACT / Pulmonary Associates, PA

Center Information

Mark H. Gotfried, M.D.
Medical Director
PACT / Pulmonary Associates, PA
1112 E. McDowell Road
Phoenix, AZ 85006
USA
602-346-4747
602-258-1113 (fax)
mgotfried@aol.com
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Contact Center

Therapeutic Areas

Cardiology/Vascular Diseases
Devices
Endocrinology
Gastroenterology
Hematology
Immunology
Infections and Infectious Diseases
Neurology
Pulmonary/Respiratory Diseases
Sleep
Urology

Center Overview

PACT’s founding physicians have been conducting clinical research for over 25 years, and our research group has grown to include three 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 6 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 5 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.

Performance Metrics

Number of Studies Conducted: 350+
Number of Studies Actually Completed: 350+
Number of Active Patients in the Database: >10,000
Regulatory Submission Turn-Around Time: 7 Business Day(s)
Average Number of Total Patients Enrolled: 10
Average Percent of Total Patients Randomized: 95%
Average Percent of ‘Completed’ Studies that met Enrollment Goals: 90%
EDC Capabilities: Yes

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

Cardiovascular
Hypercholesterolemia, hypertriglyceridemia, hypertension/diabetes, hypertension

Device
Emphysema device

Gastrointestinal
Bowel dysfunction, C. difficile diarrhea, constipation, IBS

Hematology
Anemia, deep vein thrombosis, hyponatremia

Immunology/Infectious Disease
Bacteremia, coccidiodomycosis, intra-abdominal infection, MAC, MRSA, severe sepsis, VAP/MRSA, VREF infection

Metabolic/Endocrine
Diabetic neuropathy, diabetes type 1, diabetes type 2

Musculoskeletal
Osteoporosis, premenopausal osteoporosis

Urology UTI



Sponsor Listing

  • Abbott
  • Abgenix
  • Achaogen
  • Actelion
  • Adams Respiratory
  • Advanced Biologics
  • Aeris Therapeutics
  • Almirall
  • Altana Pharma
  • Alteon
  • Amgen
  • Aradigm
  • Asthmatx
  • AstraZeneca
  • Aventis
  • Arizona Arrythmia
  • Bayer
  • BioMarck Pharmaceuticals
  • Boehringer-Ingelheim
  • Bristol-Myers Squibb
  • Braintree Laboratories
  • Bronchus Technologies
  • Cempra Pharmaceuticals
  • Cephalon
  • Chiesi
  • Chiron
  • Dey
  • Diatide
  • Emphasys Medical
  • Enanta
  • Forest Laboratories
  • Gel Tex
  • Genzyme
  • Gilead
  • GlaxoSmithKline
  • Guilford
  • Ingenix
  • Intermune
  • Johnson & Johnson Pharmaceuticals
  • King
  • Kyphon
  • Lilly
  • MannKind Corporation
  • MediciNova
  • Merck
  • Mpex Pharmaceuticals
  • Myogen
  • Neurocrine
  • Neurogen
  • Novartis
  • Orphan Medical
  • Ortho Biotech
  • Ortho McNeil
  • Otsuka
  • Parke-Davis
  • Pathogenesis
  • PEARL
  • Pfizer
  • Pharmacia
  • Phoenix Endocrinology
  • Roche
  • ROX Medical
  • RW Johnson
  • Sanofi-Aventis
  • Schering-Plough
  • Sepracor
  • Skye Pharma
  • Somaxon
  • Takeda
  • TAP
  • TEVA
  • Theravance
  • University of Illinois
  • United Biosource
  • Uptake Medical
  • Ventus Medical
  • Wyeth



CRO Partners

  • aaiPharma
  • Covance
  • i3Research
  • ICON
  • INC Research
  • Kendle
  • MDS Pharma
  • Medpace
  • Omnicare
  • Paragon Biomedical
  • Parexel
  • PPD
  • PRA
  • Premier Research
  • QDS
  • Quintiles
  • Synteract

Facility Description

PACT Main Office
1112 E. McDowell Road
Phoenix, AZ 85006
Ph.: 602-346-4747
Fax: 602-258-1113

5750 W. Thunderbird Road
Bldg. E Suite 500
Glendale, AZ 85306
Ph.: 602-515-0230
Fax: 602-515-0226



Equipment

  • 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

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.

Staff Expertise

  • 5 full-time study coordinators
  • 1 pulmonary function technician
  • 1 regulatory document specialist

Affiliations with:

  • 14 pulmonologists
  • 5 polysomnographers
  • 10 internists
  • 3 endocrinologists
  • 5 surgeons
  • 2 dieticians

Patient Demographics

Age:

  • Adult (18+)
  • Geriatric (65+)

Gender:

  • Male (50%)
  • Female (50%)

Ethnicity/Race:

  • All races

Patient Recruitment methods:

  • in-house records
  • referral
  • newspaper
  • radio
  • TV
  • website
  • mass mailing

Other Information

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.

Contact Center

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

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