Women and their OB/GYNs can select from an enormous variety of contraceptive products today. This includes multiple categories of contraceptives – oral contraceptives, implants, intrauterine devices (IUDs) or systems (IUSs), injectables, patches, rings, diaphragms and spermicides. Within categories there is usually a choice of multiple products. With contraceptives already available in such variety, it would be easy to assume that opportunities in new contraceptive development are limited. However, many women and OB/GYNs see room for improvement of contraceptives in areas including comfort, convenience, reduction in […]
Health Decisions is hosting a complimentary webinar, “Critical Success Factors in Reproductive Health Studies: Practical Tips for Minimizing Timelines, Risk and Costs.” The webinar will be held January 24, 2018. Reproductive health developers are invited to register for the complimentary webinar.
The webinar will address the challenges of conducting reproductive health studies efficiently while also generating high-quality data to support successful regulatory submissions. Topics will include:
- Recruitment, including factors such as utilizing advocacy groups and […]
Pilot studies may seem unnecessary when your investigational diagnostic is performing superbly for lab professionals in your internal labs. Why waste time and money on a pilot study when you are witnessing excellent results in the lab day after day? After all, the goal of every development program is to obtain regulatory approval, market the product and generate revenue as rapidly as possible. Let’s be honest – it takes time to identify appropriate sites for a pilot study to evaluate real-world performance by intended operators, […]
Health Decisions is offering a complimentary webinar December 14, 2017 to assist diagnostics developers in addressing regulatory changes on both sides of the Atlantic and key operational issues such as the transition to subject-based testing. Changes at FDA include faster turnaround times for some diagnostics reviews. In the EU, new Device Directives will require developers to provide more extensive evidence to obtain CE Mark, in some cases changing considerations about whether to seek approval for a novel diagnostic in the US or EU first. […]
As a leading women’s health clinical research organization (CRO), Health Decisions joins the World Health Organization and others in celebrating World Contraception Day. We view this as an occasion to recognize the progress in contraception made since the introduction of the first oral contraceptive and the first intrauterine device (IUD) in the United States almost 60 years ago. Since those early days, there has been enormous progress in oral contraception, with greatly reduced dosages and different hormonal regimens that offer women different […]
Social media are useful recruitment tools but results vary, especially as to the quality of subjects. Examples from two recent Health Decisions trials illustrate. We utilized a variety of social media in both trials, including craigslist, Facebook, a social media recruitment vendor’s sites and investigators’ social media sites. In one study, social media accounted for more than 50% of the total study subjects and more than 50% of the completers for the study. In the other, social media recruited an adequate quantity of subjects but […]
In observing International Clinical Trials Day for 2017 on May 19, Health Decisions wishes to thank all those who participate in clinical trials. Health Decisions especially thanks patients enrolled in our current trials but we want to thank trial participants everywhere for making clinical development possible.
While sponsors and CROs like Health Decisions make every effort to minimize the inconveniences and risks associated with participating in a clinical trial of an investigational drug or device, challenges are unavoidable for patients in […]
For National Women’s Health Week last year, this blog focused on the need for progress in a variety of areas in which women have unmet medical needs. Last year’s post mentioned the need for progress in noninvasive diagnostics and therapeutics for osteoporosis, female sexual dysfunction, endometriosis, bacterial vaginosis and uterine fibroids. This year we want to note progress in prevention of HPV infections […]
While drugs and medical devices are both essential in modern medical care, there are times when standard clinical development processes seem to treat medical devices as an afterthought. For example, medical writers for a CRO conducting studies of both drugs and devices must learn to interpret a drug-centric guidance document to author an appropriate Clinical Study Report (CSR) for each different type of medical device, whether diagnostic, therapeutic or surgical.
The ICH E3 guidance on the structure and content […]
As a CRO focused on clinical development of products to improve women’s healthcare, Health Decisions sees International Women’s Day as an occasion to redouble our commitment to enabling drug, diagnostics and medical device companies to bring new women’s health products to market as rapidly and efficiently as possible.
For Health Decisions, the scope of women’s health includes but is not limited to gynecological and reproductive indications. We take a broader view of women’s health that […]