- Research is a massive undertaking that many companies are unwilling to engage in for a variety of factors. This is especially true when it comes to women’s health research, and within women’s health, there is a long history of excluding pregnant women from clinical research.
- One reason for this historical exclusion is perceived “vulnerability” of pregnant women; however, at Shiphrah Biomedical Inc., we adopt the terminology of the NIH Office of Research on Women’s Health and define pregnant women in research trials as a “scientifically complex” population, which reflects a combination of physiologic and ethical complexity.
- At Shiphrah Biomedical Inc., we believe we owe the due diligence of ethical and high-impact research to pregnant and non-pregnant women, and this belief finds its basis in the four pillars of medical ethics – autonomy, beneficence, non-maleficence, justice.
- As such, evidence from well- and ethically-conducted research informs and directs our approach to product design and development.
- Informed by available evidence at every step, we engage in literature reviews; meet with key stakeholders including subject-matter experts and patients; build prototypes; manufacture low- and high-fidelity research samples; complete verification and validation testing; design, plan, execute, and publish observational studies, interventional trials for safety, efficacy, and effectiveness, and post-market surveillance and analysis.
Our Scholarly Work
- Successful design, execution, and publication of four clinical studies including 3 countries, 3 university-affiliated hospitals, 17 investigators, 407 patients, 16,890 nights of study
- Double-blind, sham-controlled, randomized clinical trial – 2015-2016
- Double-blind, randomized, sham-controlled, cross-over trial – 2015-2016
- Randomized controlled cross-over trial – 2016-2017
- Cross-sectional study – 2016-2017
- Ongoing randomized, controlled, five-way, cross-over trial – commenced June 2020
- Currently planning the largest randomized controlled trial to date in our field.
- Currently planning a first-of-its-kind observational study using novel techniques.
We are indebted to our collaborators and partners who help us carry out our research philosophy and approach to advance and improve women’s health.