Our Philosophy

  • 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.

Our Approach

  • 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

Past
  • 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
Present
  • Ongoing randomized, controlled, five-way, cross-over trial
Future
  • Currently actively planning cutting edge trials in sleep in pregnancy.

 

 

 

 

We are indebted to our collaborators and partners who help us carry out our research philosophy and approach to advance and improve sleep in pregnancy.