Reproductive Health & Women’s Health


Health Decisions offers unmatched excellence in women’s health and reproductive health.

Health Decisions is the leading CRO in women’s health and reproductive health, with deep design expertise and unmatched operational excellence in clinical development of products for a wide range of indications. Health Decisions helps biopharma and device sponsors active in women’s health on whatever scale best meets their needs, whether serving as a virtual clinical development organization responsible for entire programs, conducting US and global clinical trials or consulting on program planning, trial design and biostatistics.

Health Decisions’ Experience in Women’s Health Clinical Trials and Programs

Indications/Products

  • Contraceptives
    • Oral contraceptives
    • Spermicides
    • Microbicides
    • Emergency contraceptives
    • Diaphragms
    • Vaginal rings
    • Female condoms
  • Postmenopausal HRT
  • Sexually transmitted diseases
  • Human papilloma virus
  • Dysmenorrhea
  • Amenorrhea
  • Female sexual dysfunction
  • Vaginitis
  • Endometriosis
  • Osteoporosis
  • Pain management following hysterectomy
  • Metastatic breast cancer

Notable Achievements in Women’s and Reproductive Health

  • Development of an emergency contraceptive from the preclinical stage through design and execution of a >2,000 subject international phase III study, statistical analysis, study report and marketing approval
  • A successful >4,000 subject study of an HPV molecular diagnostic, enabling the product to reach market 2.5 years ahead of a competing product from a multinational giant and for $ millions less
  • Development of a new vaginal gel contraceptive from early clinical studies through a >1,500 subject phase III trial that provided the sponsor with a strong basis for filing an NDA
  • Current execution of a 3,400-subject fixed-cost global women’s health study with incentives for early completion
  • Successful use of risk-based monitoring in women’s health studies with Health Decisions’ Agile Risk-Based Monitoring+

Design and Operational Considerations

Health Decisions’ team of clinical experts understands the key design and operational challenges in women’s health studies:

Design Considerations

  • Developing clear primary and secondary endpoints for regulatory approval
  • Determining the sample size and other parameters that will maximize chances of meeting regulatory requirements (e.g., number of cycles, statistical requirements for demonstrating success)
  • Deciding on a superiority or non-inferiority design and negotiating non-inferiority margin with regulatory agencies
  • Evaluating the use, purpose and value of sub-studies
  • Defining subject requirements (inclusion and exclusion criteria) that will select the right population but also allow rapid enrollment (e.g., taking into account high BMI, age, sexual activity)

Operational Considerations

  • Relationships with investigators
  • Access to the right subjects
  • Identifying enrollment/recruitment challenges and developing effective contingency plans
  • Determining subject retention risks and developing effective retention strategies
  • Developing risk-based monitoring plans that simultaneously reduce SDV% and increase data quality.
  • Identifying potential risks to data quality based on site performance, personnel, CRFs
  • Ensuring consistency and quality in subject-reported data (i.e., eDiary)

View the press release, “Health Decisions Completes Enrollment of Evofem’s 3,400-subject Global Trial of Amphora® Non-hormonal Contraceptive Gel.” View case studies of a metastatic breast cancer trial and an HPV diagnostic trial.


Download a fact sheet on Health Decisions’ capabilities in reproductive and women’s health. Download Fact Sheet