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Pivotal Research Centers, LLC |
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Center Overview
Phoenix based Pivotal Research Centers LLC owns and operates three high performance, professionally managed, investigative sites in the Phoenix and Salt Lake City metropolitan areas (two in the Phoenix area) with expertise in performing large, complex clinical research studies. The sites are each staffed with an experienced principal investigator and study staff. Pivotal Research in Phoenix has a 15 bed Phase Ib/2a unit for intensive research in target patient populations.
Louis C. Kirby, M.D. founded Pivotal Research Centers in 1993. Pivotal Research has conducted over 600 trials and has completed clinical studies in 45 disciplines, working with over 65 sponsors and CROs. Pivotal specializes in CNS disorders including Alzheimer’s disease, Parkinson’s disease, depression, anxiety, migraine, mania, peripheral neuropathy, pain, and others. We have expertise in studies of bone disorders, diabetes, women’s health, obesity, and other outpatient indications which we can fill rapidly because of our access to large numbers of patients and our large and growing database of actual and potential study subjects.
Phoenix is the fifth most populous metropolitan area in the United States with over 2.3 million inhabitants. It is one of the top retirement destinations in the nation with 285,000 retirees over the age of 65. Both Phoenix based Pivotal Research sites are strategically located to access the geriatric concentration. Younger patients make up the bulk of the Phoenix area and constitute a sizeable portion of our research patients.
With a total population of 1.5 million people, Salt Lake City is one of the fastest growing areas in the United States. This unique population is the youngest population nationwide and ranks 3rd in the United States for life expectancy. Utah also ranks 4th in the United States for educational attainment. It is from the healthy population that Pivotal is able to quickly recruit and retain patients in a professional environment with well-trained and caring staff.
Pivotal Research provides rapid study start-up and proven high enrollment, with high quality assured by our intensive Quality Improvement Program and confirmed by multiple sponsor-generated audits, and an FDA audit without a 483.
Quality: Pivotal Research actively manages each study to ensure data accuracy and protocol fidelity. All charts are independently reviewed by 2 individuals prior to randomization.
Selection of the Project: It starts with the protocol review. We will not commit to a study unless we feel certain that we can successfully enroll the project.
Project Management Teams: Each project is staffed by a team that is headed by an experienced coordinator-manager. Each team is cross-trained on the studies it conducts. Members of the team participate in the study initiation meeting and subsequently address all marketing, staffing, auditing and logistical issues pertaining to the study.
Phase I Unit: our expanded Phase 1 unit has tripled in space and more than doubled its capacity to 15 beds. It is a niche multi-specialty overnight unit that specializes in highly customized adaptive trial designs coupled with our proven ability to recruit valuable patient populations for overnight studies. It complements our large phase 2 - 4 center co-located in the same building. It features comprehensive CNS and metabolic focused PK and PD capabilities with the considerable advantage of offering access to actual patients.
Our pharmacodynamic capabilities include full psychometry including Ham-D, HAM-A, MADRS, CSF fluid sampling, overnight sleep PSG, computerized cognitive testing, and dementia scales. We have experience in the Unified Parkinson’s Disease Rating Scale (UPDRS) for Parkinson’s disease with ability to take repeated, timed measures coupled with PK draws. We can perform most of the standard efficacy outcome measures for CNS diseases including most pain scales, the ADAS-cog, spasticity scales, MS disability scales, restless leg scales (IRLSS) and we offer on-site NCV capability among other measures. We can also do standard FDG-PET; f-DOPA-PET and quantitative MRI at an adjacent center.
In addition, we can do overnight trials in diabetes and obesity – importantly with fat or tissue biopsies for tissue assays. Pivotal just completed a trial with 120 abdominal fat biopsies in 60 consecutive overweight subjects, all completed within the stretch timelines set by the sponsor. We have access to full body DXA, calibrated scales, on-site dietitians, renal flow measures, anthropomorphic measures and others.
Customized Source Documents: Source documents are customized according to the requirements of the protocol and the Case Report Forms. Each visit is organized to capture all required data. Progress notes are recorded in the chart for each visit. Study charts are standardized between sites for monitoring ease.
Monitor Visit Meetings: During each monitor visit, the responsible coordinator and principal investigator meet with the monitor to review the study progress.
Staff Training: All staff members receive Good Clinical Practice and certification training. Most are certified.
Regulatory Expertise: A full-time, dedicated staff performs all regulatory functions. They have extensive experience with GCPs and regulatory requirements, resulting in excellent compliance. Consent forms are separately audited for correct completion.
Clinical Research Experience
Pivotal Research has experience in multiple therapeutic areas. We specialize in neurologic and psychiatric indications, but have wide experience in many chronic conditions. We have Phase I - Phase IV experience. Dr. Kirby has worked with pharmaceutical companies to develop and review protocols.
- CNS - Psychiatry - Neurology:
Depression, anxiety, alzheimer’s disease, psychosis, manic depression, gambling addiction, stroke, Parkinson’s disease, seizures, migraine, pain, treatment resistant depression, social anxiety, multiple sclerosis, panic, insomnia, ADHD - Musculoskeletal:
Osteoarthritis, rheumatoid arthritis, low back pain - Pain:
Painful peripheral neuropathy, narcotic pain control, non-narcotic pain control, , low back pain, post-herpetic neuralgia - Metabolic:
Obesity, diabetes, diabetic peripheral neuropathy, cholesterol - Gastrointestinal:
Endoscopically controlled ulcer, dyspepsia, obesity - Women’s Studies:
Overactive bladder, stress urinary incontinence, hormone replacement, female hormone disorder, hot flashes, oral contraceptive, birth control, menstrual cramps - Neurology:
Peripheral neuropathy, CNS indications - Opthamology:
Macular degeneration, glaucoma - Cardiovascular:
Hypertension, stroke, ischemic ulcer, angina, cholesterol - Radiology:
MRI contrast - Vaccines:
Flu, Alzheimer’s, smallpox, etc. - Urology
Incontinence, Overactive bladder, erectile dysfunction, sexual dysfunction
Pivotal has clinical capabilities in the following areas:
- Urology: Erectile dysfunction, Rapid ejaculation
Sponsors:
Abbott Laboratories, Acambis, Alpha Therapeutic Corp., ALZA Corporation, American Home Products, Astra DB, Astra USA, Inc., Astrazeneca, Baker Norton Pharmaceuticals, Berlex Laboratories, Boehringer Ingelheim Pharmaceuticals, Bristol-Meyers Squibb, Carter Wallace, Cephalon, Celgene, Ciba-Geigy Corporation, Corcept, Cortex, David, Daiichi Pharmaceutical Corp., Development Partners (PPD), DOV Pharmaceuticals, Eisai/Pfizer, Inc., Elan Pharmaceuticals, Eli Lilly and Company, Forest Laboratories, Fujisawa Research Inst., Genetech, Inc., Glaxo Wellcome Inc., GlaxoSmithKline, Hafslund Nycomed Pharma, Precision Med, Ono, Hoechst Marion Rouseel, Hoffman-LaRoche Inc., Janssen Research Foundation, Johnson & Johnson, Lorex, Labopharm, Pharmaceuticals, Merck & Co., Marion Merrell Dow, Mylan, Neurobiological Technologies, Neurochem, NeurogesX. Novartis Pharma AG, Nycomed Salutar Inc., Organon, Ortho McNeil, Otsuka, Inc., Parke-Davis Pharmaceutical, Pfizer, Pharmacia & UpJohn Co., Pharmacyclics, Inc., Protodigm, Ltd., Rhone-Poulenc Rorer Pharm., Renovis, Roberts Laboratories, Roxane Laboratories, Inc., Sankyo, Sanofi-Synthelabo, Schwabe GmbH & Co., Schwarz Pharma, Scirex, Searle & Co., Sepracor, Sention, Shire, SmithKline Beecham, Somerset Pharmaceuticals, Takeda America Research, TAP Holdings Inc., Targacept, The R.W. Johnson Pharmaceutical Res., Transform, UCB Pharma, Inc., Vanguard Medical Ltd., Voyager, Wyeth, Wyeth-Ayerst Research, Zambon Laboratories, and, Zeneca Pharmaceuticals
CRO's:
Advanced Biologics, Besselaar, Cato Research, Clinimetrics, ClinTrials Research Inc., Covance Clinical and Periapproval Srvs, i3 Research, IBRD-Rostrum Global, ICON Clinical Research, Inc Research, Kendle, MDS Harris, MDS Pharma, Medex Clinical Trial Services, Medical & Tech Research, Omnicare, PACT, Paragon Biomedical, Inc., Parexel, Pharmaceutical Product Development, Pharmaceutical Research, Pharmanet, Phoenix International, PPD - Pharmaco International,Inc., PRA, Quintiles Pacific Inc., Roche, SCIREX Corporation, Statprobe, Inc., The Hardart Group and Worldwide Clinical Trials.
Facility Description
Pivotal Research’s facilities and equipment are essential for conducting large scale, fast track clinical trials with high quality.
Peoria/Sun City Office:
- 10,000 square feet
- 6 Combination exam room/coordinator offices
- Secured drug storage area with temperature monitoring
- Private monitor room
- Large, comfortable patient waiting room
- 4 Quiet psychometry suites
- Central library for CRF storage
- IV infusion room
- Pharmacokinetic lounge
- Blood drawing station
- Laboratory processing area
- Centralized call center
- Personnel lounge and lunch room
- Dedicated space for RDE terminals
Equipment:
- -86 EF monitored freezer
- -20 EF monitored freezer
- +20 EF Refrigerated centrifuge
- 2 ECG machines
- Pulse doppler
- Pulmonary Functions (computerized)
- High capacity digital copier
Immediate Access:
- Bone densitometry: Hologic Densitometer
- Radiology: CT, MRI, Nuclear Medicine, General Radiology
- EMG/NCV: Cadwell 62000A
- SPECT: one and two head stat scanner
- Outpatient surgical suite with endoscopy and biopsy capability
- Sleep Laboratory
Mesa Office:
- 6,000 square feet
- 5 Combination exam room/coordinator offices
- 2 Quiet psychometry suites
- Private monitor room
- Secured drug storage temperature monitored
- Blood drawing/laboratory processing area
Equipment:
- -86 EF monitored freezer
- EMG/NCV: Cadwell 62000A
- -20 EF monitored freezer
- ECG machine
- Digital copier
Immediate Access:
- Ambulatory surgical suite with endoscopy and biopsy capability
- Radiology: CT, MRI, Nuclear Medicine, General Radiology
- Bone densitometry: Hologic Densitometer
- Cardiology diagnostics: echocardiogray, treadmill, and catheterization
- SPECT: one and two head
Equipment:
- PET scanner
Salt Lake City office:
- 3,000 square feet
- Exam rooms/coordinator offices
- Comfortable patient waiting room
- Private monitor room
- 4 combination exam rooms/coordinator offices
- Secured drug room with temperature monitoring
- Blood drawing/laboratory processing area
Investigator Experience
Louise Taber, M.D. – Peoria, AZ Site
Investigator and Medical Director of Internal Medicine
Dr. Louise Taber is board certified in internal medicine. She completed her medical residency at Maricopa Medical Center in Phoenix and internship at Moses H. Cone Memorial Hospital, Greensboro, NC. Her medical school was University of Arizona, College of Medicine, Tucson, AZ. She also has a Masters degree in Human Development and a BA (Highest Distinction) in Nutrition, both from the University of Maine, Orono, ME. She is a Certified Physician Investigator and a Fellow of the American College of Physicians. She has maintained her certification as a Registered Dietitian and has a keen interest in obesity, metabolism, endocrinology, and diabetes. She belongs to several professional societies and has been active in the community. Dr. Taber joined Pivotal Research Centers as a full time Principal Investigator in 2007 and Medical Director of Internal Medicine in 2008.
Troy Williams, M.D. – Peoria, AZ Site
Investigator
Dr. Williams is board certified in both internal Medicine and Nephrology and he is a Fellow of the American College of Physicians. He has past appointments as Clinical Instructor in Medicine at University of California, Irvine and Clinical Assistant Professor of Medicine at James H. Quillen College of Medicine. He has extensive experience in Internal Medicine and Nephrology acquired as: A staff physician/consultant at Good Samaritan Regional Medical Center, St. Joseph’s Hospital and Medical Center, St. Luke’s Hospital, Phoenix Memorial Hospital, Phoenix Humana Hospital, Desert Samaritan Medical Center and Carl T. Hayden Veteran’s Administration Medical Center. Dr. Williams served as project director for the NIH’s PIMA INDIAN DIABETIC RENAL DISEASE STUDY. He was principal investigator for Clinical Studies, Arizona for over thirty clinical trials with experience in multiple indications including Alzheimer’s disease, depression, osteoporosis, and women’s studies. More recently, Dr. Williams joined Pivotal Research Centers as an investigator.
Troy Williams, M.D., F.A.C.P. attended medical school at the University of Tennessee Center for the Health Sciences in Memphis. He interned at Bayford Medical Center/University of South Florida and completed Internal Medicine at Good Samaritan Regional Medical Center, Phoenix. He completed his Nephrology fellowship at The University of California Irvine. He holds active medical licenses in Arizona and Tennessee.
Sidney Spector, M.D. -- Mesa, AZ Site
Investigator and Medical Director of Neurology
Dr. Sidney Spector is a boarded neurologist and experienced principal investigator and research scientist. He has published a considerable number of articles in neural control of movement, Parkinson’s and neuromuscular disease, both in clinical and basic science. He has performed as a principal investigator in multiple trials in Alzheimer’s disease and peripheral neurology.
More recently he has been Regional Medical Director with Elan Pharmaceuticals and before that, Pfizer’s Director of the Western Region as a Medical Regional Research Specialist, CNS division. He served as adjunct professor of Exercise Sciences at Arizona State University and a guest lecturer at University of Tel Aviv following tenure as a guest researcher at Hebrew University. His doctorate is in kinesiology which he obtained at UCLA. He has a BS from University of Maryland and his MS in kinesiology is from UCLA.
Dr. Spector completed his medical education at Sackler School of Medicine at the University of Tel Aviv. Following this he performed his medical internship at St. Joseph’s Hospital (Phoenix) and finished with a residency in neurology at Barrow Neurological Institute. He then completed a clinical fellowship in Neuromuscular Diseases at the National Institutes of Health, where he conducted clinical trials in neuromuscular diseases.
Dr. Spector joined Pivotal Research Centers in 2007 as a full-time investigator.
Daniel B. Vine, M.D. - Midvale, UT site
Investigator and Medical Director of Neurology -- Midvale Office
Dr. Vine is board certified neurologist and maintains an active neurological practice in the greater Salt Lake City area. Dr. Vine’s investigative experience spans over 50 clinical trials in CNS and metabolic indications including Alzheimer’s, diabetic peripheral neuropathy, depression, anxiety, epilepsy, multiple sclerosis, Parkinson’s, obesity and insomnia. Dr. Vine attended medical school at Baylor College of Medicine in Houston, Texas and went on to complete his residency at the University of Utah. Dr. Vine is a member of the Association of Clinical Neurophysiology. In addition to holding a license to practice medicine in Utah, Dr. Vine completed a masters program in chemical engineering. He enjoys mountain bike riding in the mountains outside his home, music and reading. Dr. Daniel Vine has been a Principle Investigator with Pivotal since August of 2004.
Staff Expertise
Pivotal Research with our four sites currently has over 48 full-time employees. See below a table denoting the staff at each office:
Peoria/Sun City
- 1 - Site Manager
- 1 - Phase 1 Manager
- 7 - Coordinators
- 1 - Psychometrist
- 2 - Investigators
- 1- Nurse Practitioner
- 1 - Phlebotomist
- 1 - Receptionist
Mesa
- 1 - Site Manager
- 3 - Coordinators
- 1 - Investigator
- 1 - Psychometrist
- 1 - Phlebotomist
- 1 - Receptionist
Salt Lake City
- 1 - Site Manager
- 3 - Coordinators
- 2 - Investigators
- 1- Nurse Practitioner
- 1 - Phlebotomist
- 1 - Receptionist
Shared Staff
- COO
- 4 - Recruiters/Call Center
- 4 - Regulatory
- 1 - Human Res. Mgr./Finance
- 8 - Senior Management
- 1 - Accounting Manager
- 1 - Marketing Director
- 1 - Director of Business Development
- 1 - Human Resources/Accounting Administrator
Patient Demographics
Pivotal Research excels in the recruitment of patients for large studies across a broad spectrum of protocol requirements. Our successful track record is due to a large, diverse population, our geographic locations, focused recruitment efforts and a dedicated, well-trained staff.
Patient Population
Phoenix is the fifth most populous metropolitan area in the United States with over 2.3 million inhabitants. It is one of the top retirement destinations in the nation with 285,000 retirees over the age of 65. Both Pivotal Research sites are strategically located to access the geriatric concentration. In addition, because of the low unemployment, there is a large population of working age residents. Over 650,000 persons have moved to the Phoenix area in the 1990s making it the fastest growing in the U.S. Pivotal Research is typically one of the highest enrollers in its studies.
Salt Lake City is one of the fastest growing areas in the United States. This unique population is the youngest population nationwide and ranks 3rd in the United States for life expectancy. It is from the healthy population that Pivotal is able to quickly recruit and retain patients in a professional environment with well-trained and caring staff.
Patient Recruitment
Pivotal Research focuses on patient recruitment efforts through a variety of effective methods. We have a fully staffed call center that answers up to 100 incoming calls/day. Patients are entered directly into a computer database at the time of the call. Respondents are screened against a study specific questionnaire and potential candidates are scheduled for either office electronically. Pivotal Research’s recruitment staff also queries the database for potential candidates and makes calls to gauge their interest in participating in a subsequent study.
- Database:
Pivotal Research has its own specialized electronic database of over 30,000 patients generated through advertising and referrals. It is used regularly in mailings for new and ongoing studies. - Advertising: Television, Radio, Print, Internet
To accelerate enrollment, Pivotal Research has developed professional advertising campaigns for targeted patient audiences. We have computerized tracking systems to monitor the effectiveness of each program. - Direct Mail:
Utilizing our collective databases, Pivotal Research designs and uses effective direct mailing pieces to patients and referring physicians. - Community Relations: Health Fairs, Seminars, Event Promotion
Pivotal Research is continually involved in community activities that both increase enrollment in our studies and provide a valuable service to the communities we serve. Pivotal Research Centers has developed a network of physicians who actively assist in referral of patients into our studies. - Investigator Patient populations
The rich diversity of ages and backgrounds across our three sites contribute to Pivotal's consistent performance as a top enrolling company. Salt Lake City with 1.5 million inhabitants is the fourth fastest growing city with a younger, healthy population.
Other Information
Database Information
Pivotal Research Centers, LLC, formerly Medici Research Centers
Peoria/Sun City office:
13128 N. 94th Drive, Suite 200
Peoria, Arizona 85381
Angela Boyd , RT, MHA, CCRC
Site Manager/ Peoria
Tel. (623) 815-9714 ext 251
Fax (623) 815-9759
Email: aboyd@pivotalresearch.com
Phase I Unit
Peoria/Sun City
13128 N. 94th Drive, Suite 205
Peoria, Arizona 85381
Erica Castillo, CCRC
Manager
Direct: 623-344-3224
Fax: 623-815-9759
Email: ecastillo@pivotalresearch.com
Mesa office:
Pivotal Research Centers
1220 S. Alma School Rd. Suite 206
Mesa, Arizona 85210
Michele Aguirre, CCRC
Site Manager/ Mesa
Tel. (480) 615-3200 ext 226
Fax (480) 615-4860
Email: maguirre@pivotalresearch.com
Salt Lake City Office:
Pivotal Research Centers
6770 South 900 East
Midvale, UT 84047
Olga Johnson, CCRC
Site Manager/Salt Lake City
Tel. (801) 984-2266
FAX: (801) 567-9006
Email: ojohnson@pivotalresearch.com
Contact List:
New Studies:
Laura DeFrancisco
Director of Business Development
Direct: 623 - 344 - 3212
ldefrancisco@pivotalresearch.com
Regulatory:
Rosemary LaSalle
Regulatory Administrator
Direct: 623-344-3215
rlasalle@pivotalresearch.com
Contracts & Budgets:
Linda Schryen
Accounting Manager
Direct: 623 - 344 - 3233
lschryen@pivotalresearch.com
Marketing Manager
Ashley D. McDougal, MBA
Director of Marketing
Direct: 623-344-3220
amcdougal@pivotalresearch.com
Personnel:
Senior Management:
Michele Aguirre, CCRC - Mesa Site Manager
Angela Boyd, RT, MHA, CCRC - COO
Erica Castillo, CCRC - Phase I Manager
Laura DeFrancisco - Director of Business Development
Olga Johnson, CCRC - Salt Lake City Site Manager
Ashley D. McDougal, MBA - Marketing Manager
Linda Schryen - Accounting Manager
Sidney Spector, M.D. - Medical Director Neurology - Mesa, AZ Site
Louise Taber, M.D. - Medical Director Internal Medicine
Carol Thomas - Human Resources/ Accounting Administrator
Daniel B. Vine, M.D.- Medical Director Neurology - Midvale, UT Site
Medical Staff:
Christy Brown, N.P. - Peoria, AZ Site
Stephanie Kelly, N.P. - Mesa, AZ Site
John Newman, M.D. - Sub Investigator - Peoria, AZ Site
Robert Rankel, M,D. - Sub Investigator -Peoria, AZ Site
Sidney Spector, M.D. - Medical Director Neurology - Mesa, AZ Site
Louise Taber, M.D. - Medical Director Internal Medicine
Daniel B. Vine, M.D. - Medical Director Neurology - Midvale, UT Site
Troy Williams, M.D. - Sub Investigator - Peoria, AZ Site
Sandy Yeates, N.P. - Midvale, UT Site
Currently Enrolling Trials
CenterWatch is listing the following trials that are actively recruiting patients at this center.
- Age Associated Memory Impairment - Mesa, AZ
- Chronic Pain
- Do you have "senior moments"? Do you forget where you put your keys? Do you have trouble remembering numbers?
- Fibromyalgia Research Study
- Kidney Problems? Caused by Diabetes, High Blood Pressure, other illnesses?
- Knee Arthritis- Women 40 +
- Knee Arthritis- Women 40 +
- Knee Arthritis- Women 40 +
- Osteoarthritis of the Knee
- Parkinson's Disease...Does your medicine stop working before your next dose is due?
- Parkinson's Disease? Does your medicine stop working before your next dose is due?
- Shingles Pain...MY SHINGLES ARE GONE BUT THE PAIN IS NOT
- Suffering from Migraines?
- Tingling - Burning - Shooting pain in your feet due to Diabetic Neuropathy? (Peoria, AZ)
- Type 2 Diabetic Weight Loss - Midvale, UT
- Type 2 Diabetic Weight Loss - Peoria, AZ
- Weight Loss
- Weight Loss
- Weight Loss Research Study for Type 2 Diabetics
Contact Information
For more information, please contact:
Ashley McDougal
Pivotal Research Centers, LLC
13128 N. 94th Drive, Suite 200 (Corporate office)
Peoria, AZ 85381 USA
Phone: 623-815-9714
Fax: 623-815-9759
E-mail:
If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the E-mail form below. A representative from the research center will then follow up with you.
