Through research, we have learned that women can present different symptoms to common diseases. Because Chiltern is committed to working toward the betterment of everyone’s health, Chiltern continues to support medical device and diagnostic development for women’s health.

Chiltern has a team that includes a board-certified obstetrician-gynecologist and other medical professionals who specialize in the important health care needs that women face — adding support and value to your project with their expertise and leadership. Working as a cross-functional group, the team collaborates with you to provide specialized advice from medical, operational, regulatory and cost-efficiency perspectives. The relationships they foster with urogynecologists, obstetricians and other subspecialists, as well as investigator sites experienced in women’s health issues, allow them to provide deeper insights and strategic guidance, leading to better patient experiences, improved clinical outcomes and expedited regulatory approvals.

Chiltern has grown its women’s health experience with regard to medical device and diagnostics development. In addition to supporting different stages of development for such medical devices and diagnostics, Chiltern also supports clients with post-market surveillance studies as mandated under section 522 of the Federal Food, Drug and Cosmetic Act. Chiltern is supporting a first-of-its-kind collaboration between the FDA, industry and medical professionals in the collection and evaluation of data involving vaginal surgical mesh with pelvic floor disorder (PFDR).
Over the last five years, Chiltern has conducted 29 women’s health studies.

Women’s Health

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Total Studies

Top Women’s Health Indications From the Past Five Years

  • Bacterial vaginosis
  • Contraceptives
  • Endometriosis
  • Gynecologic surgery
  • Hypoactive sexual desire disorder (HSDD)
  • Female stress urinary incontinence
  • Minimally invasive surgery
  • Pelvic organ prolapse
  • Pregnancy
  • Sterilization
  • Uterine fibroids

Let us help you reach your program’s goals with a comprehensive range of collaborative services: