A Framework for the Application of the Bioethical Guiding Principles

Therauplex believes that biotechnology brings great benefits to life and that these technologies bring responsibility. Based on the facts available regarding the risks and advantages of the technology, Therauplex carefully considers whether to commercialize a biotechnology-derived product or therapy. The ability to perform an activity does not automatically justify that activity. As a company, these principles and processes guide our efforts to research, develop, and deliver critical therapeutic products to patients around the world.

Guiding Principles of Bioethics

Therauplex makes the safety and efficacy of its products a top priority and supports government agencies that protect health and well-being around the world.

Clinical Trial Transparency and Data Sharing Policy

Clinical trial registration

Therauplex will compile all industry-sponsored human clinical studies into an ICMJE-approved registry, including key safety and efficacy endpoints from feasibility (Phase 1b) to post-marketing (Phase 4 intervention studies). Type and/or register on the website. Rules.  Bioequivalence studies (Phase 1) do not require registration unless required by law.

Disclosure of results

Therauplex publishes the results of completed applicable human clinical studies (such as summaries of clinical study reports) for devices or products commercialized within one year of study completion or within 30 days of regulatory approval or clearance.