Center Overview

Women’s Health USA Clinical Trials Division provides a comprehensive infrastructure for the performance of clinical trials to 82 Principal Investigators at 22 sites throughout Connecticut, and seven affiliated states including Florida, Louisiana, Maryland, Ohio, Tennessee, Virginia and Alabama. All our investigators are members of the largest private practice in the country offering the best available medical care...including enrollment in clinical trials--to almost 1 million women patients. Women’s Health’s centralized clinical trials services include budgeting and contracting, regulatory submissions, training and support to principal investigators and clinical research coordinators, a common IT platform with internet access, patient recruitment, quality assurance and coordinator backup. The information network allows physicians to quickly identify qualified patients and maintain a growing database of volunteers.

Clinical Research Experience

We have completed 39 studies since 1998 (Phases II, III & IV), in the areas of pregnancy, fibrocystic breasts, incontinence, female sexual dysfunction, osteoporosis and urinary tract infections. Twenty studies are currently in progress or will start in 2002 including:

• PMS
• Fibroids
• Hot Flashes
• Endometrial Safety
• Female Sexual Dysfunction
• Unstable Bladder
• Endometriosis
• Urinary Tract Infections
• Urinary Incontinence
• Yeast Infections
• Gestational Diabetes
• HRT/Menopause

Companies we have worked with include:

Pharmaceutical and Biotechnology Companies

• Bayer
• Berlex
• CuraGen
• Eli Lilly
• Glaxo-Wellcome
• Organon
• Personal Products Company (J & J)
• Pfizer
• Pharmacia
• Praecis
• Procter & Gamble
• Sepracor
• GlaxoSmithKline
• Symbollon
• TAP

CRO’s

• IBAH
• Parexel
• PPD
• Quintiles

Internet

• Phase Forward

Facility Description

We currently have 15 investigative sites throughout the state of Connecticut and our affiliated states, with practices dedicated to women’s health. We offer all office procedures specific to gynecology, obstetrics, reproductive endocrinology and urology including bone density, mammography, biofeedback, ultrasound and access to outpatient surgical centers. The sites are well-equipped and staffed by clinical research professionals with experience in the latest technologies including electronic CRFs.

In addition, we have other multi-specialty investigators at affiliated sites in Connecticut, Louisiana and Florida. Conveniences of our sites include:

• Locations within 1 hour of major airports
• Access to public transportation
• Proximity to interstate highways
• Free parking
• Internet access and e-mail

Investigator Experience

All principal investigators (82 ob/gyns and 2 urologists) are board certified and have completed a comprehensive training program. Among our investigators are experts in many areas of women’s health including Dr. Benson J. Horowitz who is recognized world-wide as a thought-leader in the area of yeast infections and vaginitis/vaginosis, and Dr. Jill Peters, a noted urologist with extensive research experience in urogynecology. Some have completed as many as 20 trials over the past 30 years while maintaining a full time practice. Many hold faculty positions at the University of Connecticut School of Medicine and administrative positions at local and regional hospitals. Our women’s health sites offer subspecialties in urogynecology, reproductive endocrinology, female sexual dysfunction and perinatology.

Staff Expertise

Our committed staff includes 27 trained, full-time coordinators (10 part-time), including six nurse practitioners and one certified nurse midwife. They are well-equipped and experienced including proficiency with electronic CRFs. Several sites are bilingual and one is multilingual.

Patient Demographics

With a current population of more than 350,000 female patients throughout Connecticut, and almost 400,000 women patients at our affiliated sites, we can identify subjects by ICD-9 codes, CPT codes, age, geography, medical history, marital status and any combination of these criteria.

Patients are recruited from our database, intra- and extra-network referrals and use of both broadcast and print media.

Other Information

Why Select Women’s Health USA for Your Clinical Research?

Performance and Experience

• 39 Phase II through Phase IV studies by our sites since 1998
• Key sites met or exceeded enrollment targets
• Experienced, well-trained and motivated Principal Investigators
• Less than 2% data queries on Case Report Forms
• 24 hour response on data queries

Real World Setting

• Principal Investigators conduct studies within their own practice environments
• Physician involvement in research can lead to early adoption of approved therapies
• Opportunities exist for patient education, community outreach, focus groups and marketing research

Recruitment Ease and Speed

• Central database allows for immediate identification of qualified female subjects
• Selection criteria includes diagnoses, procedures, demographics and medical history
• Principal Investigator screening and recruiting of subjects is part of total patient care
• Subject retention through automated scheduling, tracking and reminder programs
• Large group practice environment facilitates network referrals

Efficient Centralized Services

• Single point of contact
• Rigorous training program for Principal Investigators and Clinical Research Coordinators
• Comprehensive project management using Study Manager™ software
• IRB approved Standard Operating Procedures for all sites
• Use of Central IRBs
• Quality Assurance standards for sites
• Comprehensive source document preparation
• Submission of regulatory documents with 48 hour turnaround
• Budget and contract preparation with 48 hour turnaround

Focus on Women’s Health and Therapeutic Areas Affecting Women

Contact Information

June Petillo
Women's Health USA
Clinical Trials Division
22 Waterville Road
Avon, CT 06001
USA
Phone: 860-678-5520
Fax: 860-677-5557
EMail: jpetillo@womenshealthusa.com
Web Site: http://www.womenshealthusa.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.