Growth in women’s health research has been fueled in part by an increased awareness of hormonal disorders. More than 300 clinical trials were planned for 2017, with 40% in phase I/II of women’s health research.
There are often unique barriers to enrolling women’s health trials. Women may be less willing to accept the health risks, for instance while pregnant or hoping to become pregnant.
We have proven solutions to overcome the challenges associated with women’s health trials, including management of vendors and use of specific adaptive trial design processes.
Accelerated recruitment timelines
We have highly experienced Clinical Enrolment Managers across women’s health indications. You will be offered a customised recruitment strategy for your study, and support executing on the plan. The site team will also get full support in building a roster of patients prior to recruitment and our processes reduce lengthy timelines, and provide pre-screening transparency. The focus is on supporting and enabling sites to meet your enrolment targets.
This stage is easier and faster for you as it also eliminates the need for manual chart review.
100%Ahead of, or on, schedule target date First Patient Enrolled and Database Lock All women’s health projects during the last three years
ICON combines best practice processes with innovative technology to deliver the best solution for your trial
FIRECREST, our industry leading digital solution for site training and communication supports both study and site staff to manage and empower patient participation. This technology has effectively supported numerous studies involving women’s health, including cancer and HIV-1 studies.
Our eTMF system provides remote access which allows sponsors to maintain full oversight of the trial. With this technology, you can locate study documents with just a few clicks, and keep your notes within the eTMF.
We also have detailed understanding of the design requirements of PRO instruments in this area and support the design and implementation to optimise the data collated.
You can make use of our 180 bed Clinical Research Unit with a patient database of 15,000 to execute Phase I and Proof of Concept studies, including:
- Post-menopausal/vasomotor symptoms
- Uterine fibroids
Our medical imaging team can provide advice and implement:
- Measuring uterine physiology and anatomy through several imaging methods
- Detecting endometriotic implants and endometriomas by ultrasonography and MRIs
- Hysteroscopy to detect endometrial polyps in postmenopausal women
ICON has extensive experience in this area and we have 15 ICON women’s health medical device studies currently taking place in areas such as urethral support systems, sutures, and cryopreservation.
Full instrument development services will be provided for you, including concept elicitation and content validity assessment.
You will receive advice on endpoints and device selection. Our teams have significant expertise in capturing objective data directly from the patient using wearable technology. This is particularly useful in diseases where sleep disruption is a common feature.
Experience you can trust
We have over 40 Project Managers, 130 Clinical Trial Managers, and 160 CRAs with women’s health trial experience. Your clinical trial will have a dedicated leader overseeing the Women’s Health portfolio, along with two board certified gynecologists and an endocrinologist. They have expert therapeutic knowledge of the area, offering you a tailored approach based on the specific needs of your trial.
100% Ahead of, or on, schedule target date
First Patient Enrolled and Database Lock
All women’s health projects during the last 3 years
200+ Oversight of ePRO studies
1,100+ Investigators registered in our database