Like the women who enrol in our studies, no two women’s health trials are the same.
ICON employs the industry’s top drug development talent, enabling us to better partner with our clients in developing products to prevent and treat diseases and disorders affecting the health and quality of life for women around the world. Our clinical research professionals are therapeutically aligned with a leadership team that is focused specifically in women’s health.
The breadth of our operations
Our team is adept in the causes, symptomology, progression, standard of care, and best practices across a broad range of women’s health indications. These individuals bring forward hands-on experience in the delivery of women’s health trials. They work collaboratively with ICON physicians, therapeutic and operational experts to ensure all our trials meet regulatory standards both effectively and ethically. We ensure each site is thoroughly trained and has the appropriate Principal Investigator and / or Study Coordinator support. We closely monitor data trends to support early risk identification and mitigation.
ICON Women's Health experience in the last five years
Integrated full service solution
We deliver a full service solution with all ancillary services integrated into study teams. This expedites timelines and enhances trial execution by simplifying site contracting and management, minimizing risk and eliminating communication barriers. Some of our key services include:
Managing women's health trial complexities
- Data analytics of PRO endpoints to detect placebo response and prevent reoccurrence using our FIRECREST Placebo Response training module
- Study teams proficient in the delivery of studies requiring TVU, DEXA, mammogram, endormetrial biopsiy, endpoint collection using PROs
- Relationships with approximately 1,000 high performing sites on active women's health studies in North America, Europe, Latin America, and Asia Pacific
- Proven design and management of successful patient recruitment campaigns. For example, a large Phase III women’s health study fulfilled target participants screened milestone within 6 weeks of a planned 5-month campaign
All women’s health projects during the last 3 years achieved first partcipant in and/ or database lock on time or ahead of schedule
Areas of expertise
- Menopause-related disorders: VMS, endocrine/ metabolic disorders
- Postmenopausal osteoporosis
- Endometriosis, uterine fibroids & bleeding disorders
- Pregnancy disorders and management: Preeclampsia, contraceptives
- Sexual health: Female sexual dysfunction, sexually transmitted infections
- Reproductive Disorders: Infertility, assisted reproductive technology, polycystic ovarian syndrome
- Breast cancer supportive care
- Maternal immunisation/ passive immunity
- Urinary incontinence/ overactive bladder
- Amenorrhea, dysmenorrhea
- Postpartum depression
Women's Health panel at Financial Times Global Pharma conference
Women’s healthcare has been largely underserved and underfunded, yet there is significant scope for innovation. Deirdre Albertsen, ICON's head of Women's Health, joins a distinguished panel for discussion on femtech, development of treatments and under representation of women in drug trials.