Center Overview

Northern Indiana Women's Health Research conducts Phase II, Phase III, Phase IV, and Investigator-initiated clinical research trials.

The research center is located next to and affiliated with Houser-Norborg-MacGregor Medical Corporation, a full-service Ob/Gyn practice serving South Bend, Indiana and the neighboring communities of northern Indiana and southern Michigan for over 35 years.

The practice is staffed by nine board-certified Ob/Gyn physicians and three certified nurse practitioners. With a patient database of over 35,000 patients and an average of 1,200 patient visits per week, our teams provide fast recruitment and enrollment for all studies involving all areas of women's health. Our research center can comfortably accommodate clinical trials that also include male subjects, with a separate clinical area devoted to research.

Clinical Research Experience

We have been involved in clinical research since 2001, working with numerous sponsors and CROs. We conduct clinical trials related to multiple health issues including, but not limited to:
-- osteoporosis
-- menopause
-- estrogen receptor modulators
-- hormone therapy
-- climacteric symptoms
-- vaginal atrophy
-- sexual dysfunction
-- vaginitis
-- cervical disease
-- human papilloma virus
-- pelvic pain
-- endometriosis
-- infertility
-- pelvic adhesions
-- uterine leiomyomata
-- contraceptives
-- menstrual control
-- menorrhagia
-- premenstrual syndrome
-- premenstrual dysphoric disorder
-- weight loss
-- insomnia
-- mood disorders
-- surgical devices
-- Herpes treatment
-- menstrual migraines
-- anemia
-- breast pain

Facility Description

Our facility is next door to a full-service Ob/Gyn practice and across the street from Memorial Hospital of South Bend, a 526-bed regional referral center for cardiac, cancer, childbirth, emergency medicine and rehabilitation services. We have experienced investigators and study coordinators that provide rapid recruitment and enrollment.

Our site features the following:
-- quality assurance procedures
-- electronic data entry
-- collaboration with national screening centers
-- state-of-the-art information transmission
-- archiving of study documents
-- onsite lab with CLIA certification
-- locked refrigerator
-- freezer to -50%B0C
-- locked drug storage cabinet
-- ECG machine
-- ultrasound
-- bone densitometry
-- colposcopy
-- separate research entrance
-- office minor surgery
-- financial and regulatory documentation
-- quality data
-- HIPPA compliance
-- trained research team in FDA regulations, ICH & GCP Guidelines

Investigator Experience

Jeanne E. Ballard, M.D., FACOG-- medical director and principal investigator, board certified OB/GYN: experienced research in Phase II-IV studies, research protocol design, public speaking and speakers bureaus, and leadership in women's health care. CV available upon request. Research experience includes menopausal medicine, osteoporosis, gynecologic infectious diseases, contraception, PMS, mood disorders, and hormonal therapy.

Keim Houser, M.D., FACOG-- board certified OB/GYN, 30 years clinical and research experience, special interests in menopausal medicine, laparoscopic surgery and pelvic floor reconstructive surgery.

Elizabeth Fourman, M.S.N., C.N.P., women's health and OB/GYN nurse practitioner with special interest in infectious disease, contraception, nutrition and weight management.

Janelle Blickensderfer, D.O., FACOOG-- board certified OB/GYN specializing in all areas of obstetrics and gynecology.

Karen Lesch, C.N.P.-- women's health and OB/GYN nurse practitioner with special interest in menopausal medicine and family planning.

Cynthia Reese, C.N.P.-- women's health and OB/GYN nurse practitioner with special interest in sexual therapy, mood disorders, infertility and family planning.

Staff Expertise

Terri Stoll, R.H.I.T., C.R.C.C., C.C.R.P., Director of Clinical Research: extensive clinical research experience, including expertise in trial coordination, preparation of regulatory documents, IRB, site initiation and qualification, advertising, phlebotomy, laboratory procedures, injections, drug accountability and dispensation, study management and completion.

Kim Parsons, R.N., experienced clinical coordinator with background in cardiology, obstetrics, gynecology and women's health, phlebotomy, electrocardiograms, injections and infusions.

Melanie Sulok, C.M.A., clinical research assistant, bone densitometry, phlebotomy.

Patient Demographics

Our research patients come from both our clinical practice and from recruitment and referral. The associated Ob/Gyn patient database has over 35,000 patients, with the practice averaging 1,200 patient visits per week. Our population represents women of all ages, races, professions and levels of education. Our site has also participated in clinical trials with male subjects, with a separate clinical area devoted to research.

Other Information

We are the largest service area within a two-hour radius of Chicago, Indianapolis, Grand Rapids (MI) and Fort Wayne (IN). Our facility uses a central IRB, and can work with either a central or local lab, depending on the study requirements.

Contact Information

Jeanne E. Ballard, M.D.
Medical Director
Northern Indiana Women's Health Research, Inc.
505 North Lafayette Blvd.
South Bend, IN 46614
USA
Phone: 574-280-3946
Fax: 574-280-3945
EMail: ballard77@msn.com
Web Site: http://www.niwhr.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.