Center Overview

Precision Trials (formerly know as Arizona Wellness Center for Women) has been performing clinical trials since 1987. Precision Trials is known for its dedication and ethical performance of clinical research studies. Using good clinical practices we are able to complete studies in a timely, ethical and efficient manner.

Clinical Research Experience

Precision Trials affords sponsors exposure to clinical investigators with more than 20 years of combined clinical research experience, along with a staff of certified clinical research coordinators. Precision Trials has a proven track record of rapid enrollment, treatment and patient compliance. Precision Trials conducts Phase II-IV drug and device trials.

CROs

Facility Description

Precision Trials is at the forefront of clinical research in one of the nation’s fastest growing cities. Centrally located close to two major freeways gives easy access to our facility and draws patients from a wide local area map. We are located next to Paradise Valley Hospital; a level 2 acute care 140-bed hospital. Procedures available at our facility include ultrasonography, colposcopy, endometrial biopsy, hysteroscopy, LEEP procedures.

Facility

• 10,000 sq. feet office complex adjacent to Paradise Valley Hospital
• 11 fully equipped gynecology exam rooms
• 2 ultrasounds including transvaginal
• 1 external fetal monitor
• 1 procedure room
• 14 physician and support staff office rooms
• Lunchroom, waiting room
• High speed secure Internet on two T1 lines
• Secure climate controlled storage for medications
• -20° Freezer
• Secure storage for CRFs & Source Documents
• Radiology, Dexa, EKG services
• 24-hour emergency pager
• 2 Centrifuge’s, 1 refrigerated
• 2 microscopes
• 2 culposcopes
• In-office flexible hysteroscope with video
• Autoclave
• Secure drug storage
• Monitor work area
• Refrigerator
• HIPAA compliant

Investigator Experience

Steven J. Wininger, M.D. F.A.C.O.G., CCTI
Steven Wininger, M.D. received his certification for Clinical Trial Investigator (CCTI) in the spring of 2005. Dr. Wininger's dedication to conducting quality research enables Precision Trials to remain a high quality and desirable site to many sponsors. Dr. Wininger graduated from Tufts University School of Medicine in 1989 and completed his residency in obstetrics and gynecology at Pennsylvania Hospital in Philadelphia. He has been on the clinical faculty at Tufts University School of Medicine and the University of Pennsylvania as a clinical instructor. He has served as adjunct assistant professor at Midwestern University School of Medicine in Phoenix. Dr. Wininger is a skilled Laparoscopic and Hysteroscopic surgeon and is dedicated to preventive medicine, patient education, and development of novel therapies through clinical research. Dr. Wininger is presently on the Board of Directors at Paradise Valley Hospital. Dr. Wininger has been conducting research and serving as an investigator for 10 years.

Valerie Sorkin-Wells, M.D. F.A.C.O.G.
Dr. Sorkin-Wells had been practicing OB/GYN in the valley since 1986 and has earned a reputation that is unsurpassed in Phoenix for comprehensive care. Dr. Sorkin-Wells champions alternative and complimentary therapies, as well as conducting clinical research. Dr. Sorkin-Wells has been conducting clinical research for the past 10 years. Dr. Sorkin-Wells graduated from the Medical College of Toledo in 1982 and completed her residency training at Sinai Hospital in Baltimore in 1986.

Nancy B. Harris, M.D. F.A.C.O.G.
Dr. Harris graduated from Brown University in 1982 and completed medical school at Case Western Reserve School of Medicine in 1986. She completed her residency training at Mt. Sinai Medical Center in Cleveland and spent the next four years in private practice. In 1995, she joined Drs. Smith, Wininger, and Sorkin-Wells. Dr Harris has been conducting clinical research since 1996.

Rodney H. Smith, M.D. F.A.C.O.G
Dr. Smith graduated from Southern University School of Medicine in 1979 and following an internship in Chicago, he completed his residency at Tripler Army Medical Center in 1982. Dr. Smith served as chairman of the Department of OB/GYN at Phoenix Baptist Hospital from 1992 to 1996 and is presently on the clinical faculty at the Kirksville Medical School. He has taught family practice residents at Phoenix Baptist Hospital and has served as adjunct assistant professor at Midwestern University School of Medicine. He has done extensive research as a clinical investigator for numerous drug trials and has been a physician in the valley for greater then seventeen years.

Heather L. Roth, M.M.S. PA-C
Heather graduated for the University of Arizona in 1996 and then went on to Midwestern University for her masters and Physicians Assistant Degree. She graduated in 1999 with her Masters in Medical Science and is a board certified Physician Assistant. She is also on the adjunct faculty at Midwestern University. "My goal is to make patients feel very comfortable with me," says Heather. "I enjoy educating my patients about wellness and disease prevention." Heather has been conducting research since 1999 as a sub investigator.

Donna Figaro-Sheffey, PA-C
Donna completed her medical training and graduated from the State University of New York at Stony Brook in 1982. She earned her Bachelors Degree and is a Board Certified Physician Assistant. After 10 years of practicing in Internal Medicine, she followed her heart and focused her practice to Women’s Health. In 1997, Donna completed additional training in Colposcopy Clinical Education thru the American Society for Colposcopy and Cervical Pathology at Columbia University in New Your. She has taught and precept PA Students and is an active member of the Association of PA’s in OB/GYN

Staff Expertise

Amy S., CCRC
Director, Clinical Operations
Amy D. Saenz is a certified clinical research coordinator through ACRP with 10 years of experience as a coordinator and 5 years experience as a site director. Amy's areas of experience vary from allergy and asthma research to internal medicine and women's health. She has extensive experience in the areas of GCP compliance, business development, clinical trial operations and coordination.

Kate Y.
Director, Marketing & Recruitment
Kate is experienced in grass-root level companies working primarily in Marketing and Business Development. She previously held a position for a multi-site catastrophe company accomplishing #30 of 500 fastest growing companies by INC Magazine for 2007. Kate also has experience in concierge medicine practices from pre-conversation/patient recruitment stages to post-conversion business development management.

Kris C., CCRC
Clinical Research Coordinator
Kris has been in the research field for the past 17 years, certified as a researcher by ACRP for 15 years. She has worked on Phase II - IV trials including Pharmaceutical, Device, Surgical, and Post Market. Kris has worked on over 100 trials during this time period in the following diseases: Internal Medicine, Rheumatology, Gastrointestinal, Women's Health, Men's Health, Pediatric, Geriatrics, Asthma and Allergy, Dermatological, Post Surgical Pain, Chronic Pain, Weight Loss, Psoriasis, Depression, Diabetes, Cardiology, Migraines/Headaches, Infectious Disease, and Alzheimer's.

Pam K., CCRC
Clinical Coordinator
Pam has been in research for 16 years, of those 12 years she has been certified by the ACRP as Certified Coordinator. Pam’s specialized areas of interest concerning clinical trials are: Phase I - Phase III b, Pediatrics through Geriatrics, topicals to IV, Surgical, Labor, Dermatological, Cancer/Oncology, Psoriasis, Depression, Diabetes, Asthma and Pain Management.

Laura V., CCRC
Clinical Coordinator
Laura has worked in the Research Industry for over seven years as a Clinical Research Coordinator. She has conducted research trials for numerous indications. Laura became a Certified Clinical Research Coordinator in 2005 and has successfully maintained her certification over the years. Prior to working in the Research Industry Laura graduated as a Medical Assistant, from The Bryman School of Allied Health in 1997. Medical Assisting gave her a superior foundation to build on in the Health / Research field.

Today Laura's therapeutic areas of experience include: gynecology, cardiology, endocrinology, neurology, chronic pain, gastroenterology, orthopedics, post operative pain, and weight loss. Laura has worked on all phases of studies from Phase I - Phase IV. She also has experience conducting Surgical and Device studies.

Dena S.
Clinical Research Coordinator
Dena has been enjoying her career in clinical research since 2006. She started her career at a Phase I unit in Tacoma, Washington as a Clinical Research Technician. It was there that she built her foundation for research prior to becoming a Coordinator.

Based on her progress and understanding of GCP, NIH and research conduct, she was given the opportunity to advance her career as a Coordinator. From there she has obtained experience in Phase II and Phase III clinical research trials. She has worked in therapeutic areas ranging from HIV, HCV, Migraines, Diabetes and Women’s Health.

Sharon J.
Regulatory Coordinator
Sharon has been in Clinical Research for 12 years in various positions making her a well rounded employee as part of our team. From scheduling to accounting to regulatory affairs, her experience is vast and well accepted into any new site we establish.

Additional Staff:

• Research Assistants
• Four Medical Assistants
• ARDMS Sonographer
• 2 Registered OBGYN Nurse
• 2 Certified Physician Assistants

Patient Demographics

• Caucasian 74%
• African American 9%
• Hispanic 15%
• Asian 1%
• Native American 1%
• Pediatric ( birth - 12) 1%
• Adolescent (13-17) 15%
• Reproductive Age ( 18-50) 55%
• Menopausal 29%
• Database 50,000 + Female Obstetric and Gynecology patients
• Average daily patient census: 80 - 100 scheduled appointments

Other Information

Precision Trials can use a central IRB.

Office Procedures

• Pregnancy and pelvic (GYN) ultrasonography including transvaginal
• Leep cervical conization
• Cryotherapy
• In-office diagnostic hysteroscopy
• Bladder catherization
• Uterine (endometrial) biopsy
• Colposcopy
• Urine analysis with microscopy
• Breast cyst aspiration
• Endometrial (Uterine) Ablation
• Ultrasonography, EKG

Procedures Hospital Based

• Pelvic surgery including laparotomy, laparoscopy and operative hysteroscopy
• Incontinence surgery
• Cesarean delivery
• Laparoscopic hysterectomy

Interests Include:

• Contraceptives including contraceptive devices
• Hormone replacement therapy
• Postoperative pain management and nausea/vomiting
• Surgical devices
• Vulvovaginal disease
• Breast disease and lactation
• Libido and sexual dysfunction
• Menopause
• Premenstrual syndrome
• Urinary incontinence
• Urinary tract infections
• Female sexual dysfunction
• Osteoporosis prevention and treatment
• STD’s
• Abnormal Pap’s, HPV and cervical dysplasia
• Dysfunctional uterine bleeding, menorrhagia
• Poly cystic ovarian disease
• Endometriosis
• Uterine Fibroids
• Laparoscopy and Hysteroscopy
• Gynecologic surgical devices
• Dysmenorrhea
• Vulvovaginits, yeast, bacterial vaginosis

Contact Information

Amy Saenz
Director, Clinical Operations
Precision Trials, LLC
3815 East Bell Road, Suite 4500
Phoenix, AZ 85032
USA
Phone: 602-931-4507 x 223
Fax: 602-923-3129
EMail: amys@precisiontrials.com
Web Site: http://www.precisiontrials.com

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.