Clinical Research at
Blues Skies Center for Women's Services
Site Specific Information for Sponsors Seeking Investigative
Sites
Blue Skies Center for Women
Clinical Research Site
General Information
Blue Skies Center for Women is the private Obstetrics and Gynecology practice of Andrew Fowler,MD and Stephanie Fowler,MD. Our staff of providers/investigators also includes: Debora Chan, MD, three certified women's health care nurse practitioners and two certified nurse midwives. All three physicians are board certified in Obtetrics and Gynecology. We hope the following information will be of help to you in evaluating our practice as a potential investigative site.
Commitment to Clinical Research: Blue Skies Center for Women views clinical research participation as a priority, not a peripheral interest. We have dedicated the necessary time, space, equipment and training of personnel to conduct studies efficiently and carefully. Our goal is to expand and continue our involvement in clinical research. We are happy to adjust our practice schedule to accommodate the requirements of participation in clinical research projects.
Practice Profile
Blue Skies Center for Women is a growing, private, group, OB/GYN practice with a current active patient population of over 17,000 women of varied ethnic backgrounds. The vast majority of our established clients are well-educated women residing in our community (which has proven to provide compliant and stable study participants). Our patient population spans the full age spectrum from adolescent to post menopausal women (providing potential study populations for a wide range of products, medications and devices). The emphasis of our practice will continue to be in gynecology and clinical research. Having eight providers enhances our recruitment efforts. Our excellent reputation as a clinical research site also affords us referrals from other local practices as well as enthusiastic responses to community advertising
Research Staff
- Debra Baker, RxN, CNP, CCRC is our full time Certified Women?s Healthcare Nurse Practitioner and ACRP Certified Clinical Research Coordinator. She has served as a clinical research coordinator and Subinvestigator since 1989. Her ACRP certification is additional assurance that any studies entrusted to us will be conducted in accordance with the highest standards of Good Clinical Practice Guidelines.
- Stephanie Fowler, MD has served as Principal Investigator for our studies since 1999. Andrew Fowler, MD, Debora Chan, MD and Debra Baker serve as Subinvestigators.
All members of our office staff are experienced with following project protocols, screening study subjects, and data management.
Enrollment History
We are proud of our record of rapidly enrolling carefully screened well-qualified subjects. We also take great pride in our history of meeting and exceeding our contracted enrollment goals. Our records reflect an excellent percentage of completed subjects in all of our studies.
Experience
Past studies have included both short and long-term projects (ranging from three month to two-year commitments). We are experienced in studies evaluating dysmenorrhea, vaginitis (candidiasis and bacterial vaginosis), Polycystic Ovarian Syndrome, oral contraceptives, cervical dysplasia/human papilloma virus, hormone replacement (vasomotor symptoms, endometrial hyperplasia, lipids and bone markers) as well as non-hormonal prescriptive medications and dietary supplements for vasomotor symptoms. In addition to these areas, we would welcome the opportunity to participate in any studies relevant to women's healthcare including (but not limited to): osteoporosis, fibroids, menstrual disorders, contraceptive medications/devices, pain relief, surgical devices/products, sexually transmitted infections, PMS, menopausal concerns, cervical disorders, urinary incontinence and infections, female sexual dysfunction, hormonal and non-hormonal gynecologic products, and female obesity.
Prior Sponsor Affiliations
We view the ongoing professional relationship we enjoy with several of the Sponsors and Clinical Research Organizations with whom we have done multiple studies as a reflection of their satisfaction with the consistent quality of our services. We have had the pleasure of working with both national and international pharmaceutical sponsors including:
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Facility
Blue Skies Center for Women is centrally located in Colorado Springs, Colorado and is within 1.5 miles of Memorial Hospital. Our large office includes fifteen exam rooms, onsite ultrasound, colposcopy and LEEP capability as well as laboratory facilities with appropriate CLIA certification for phlebotomy, incubation of cultures, hemoglobin measurement, urine testing (dip urinalysis, pregnancy tests), wet mounts/Affirm vaginitis screens and preparing blood, urine and tissue samples for shipping to central laboratories. Freezer storage for laboratory samples is available. Locked storage facilities are on site for study test articles and document maintenance. Ample office space, equipment and internet access are available for CRA monitoring visits.
Local Resources
We are affiliated with several excellent hospital, EKG, laboratory and radiology facilities who are experienced with clinical research requirements for those occasions when Sponsors desire services be outsourced to local entities rather than arranged through central facilities.
We appreciate your interest in Blue Skies Center for Women as an investigative site. You may be assured of our commitment to integrity and excellence in conducting clinical research trials in accordance with the highest standards of Good Clinical Practice Guidelines. We will devote all of our resources to joining you in a productive and profitable relationship. If you desire further information or have questions, please feel free to contact our Clinical Research Coordinator: Debra Baker RxN, CNP, CCRC at 719-471-3471.