Digital Clinical Development Services Company Transparency Life Sciences Awarded U.S. Patent For Combined Protocol Crowdsourcing And Digital Data Collection Platform
Published: Sep 06, 2017
NEW YORK, Sept. 6, 2017 /PRNewswire/ -- Transparency Life Sciences (TLS), the first all-digital clinical development services company, today announced that the U.S. Patent and Trademark Office has issued a patent covering key aspects of the company's integrated approach combining data transparency, crowdsourced clinical protocol design and digital patient data collection. This patent is considered especially significant given a high-profile 2014 Supreme Court ruling that set a high legal standard for software and business method intellectual property. The new TLS patent reinforces the distinctiveness of Transparency's approach to clinical development that encompasses a broad class of therapeutic areas and clinical development stages.
"The granting of this patent, which protects key elements of our transformational approach to clinical drug development, is a major validation of the TLS model," said Tomasz Sablinski, MD, PhD, co-founder and CEO of TLS. "We established TLS as a 21st Century alternative to an outmoded, inefficient and expensive legacy model. The TLS approach involves patients and other stakeholders in the development of more patient-focused and informative clinical trial designs that are executed using digital technologies. This results in greater clinical trial participation by highly engaged patients and generation of truly informative clinical research data with the potential for major cost savings."
TLS's end-to-end integrated digital rethink for clinical development is built on three pillars:
- TLS's Protocol Builder harnesses the power of patients and other stakeholders to design patient-centric, clinically and regulatory-relevant trial protocols.
- site.TLS virtual trial and data platform leverages advances in mobile health, increasing acceptance of telemedicine in health care services and rapid progress in wearable devices technology to execute informative, cost-effective clinical studies that are more convenient for patients and minimize site visits.
- Transparency throughout the process builds credibility with patients and other key stakeholders.
Marc Foster, co-founder and COO of TLS, noted, "This patent issuance for our core approach is the most recent sign that transparent, crowdsourced, digitally-executed clinical trials are gaining wide acceptance. TLS was the first to obtain FDA clearance for a crowdsourced, digitally-focused clinical trial. The FDA continues to demonstrate support for the innovative approaches we've pioneered by approving a digitally-executed, virtual trial for a new drug that leverages our proprietary technology. We have successfully implemented these approaches in central nervous system, autoimmune, cancer and other major therapeutic areas, and are now excited to make 21st Century clinical trials available to biopharma drug developers of all sizes. We expect that TLS's expanding intellectual property estate, including this newly issued patent, will contribute to growing industry awareness and acceptance of novel clinical trial approaches and technologies."
U.S. Patent Number 9,747,424 relates to systems and methods for clinical drug development under a transparent and novel online model that allows a broad range of clinical research stakeholders to contribute to clinical protocol design. The system also allows for use of an integrated drug development engine to manage execution of the clinical trial, including digital and other remote means of collection of health and treatment information and measurements from clinical trial participants. Where feasible, the model aims for data transparency throughout the process.
About Transparency Life Sciences
Transparency Life Sciences (TLS) is the first all-digital clinical development services company. Rapid advances in digital technology and strong regulatory support create a historic opportunity for TLS to catalyze a fundamental transformation in clinical trial design and execution, significantly improving the quality of clinical trials while reducing their overall cost. TLS's approach combines crowdsourcing and mobile health technology to advance drug candidates through clinical trials with unprecedented efficiency and patient and regulatory relevance. The use of digital technology allows TLS to reduce or eliminate reliance on physical study sites that are expensive, complex and inconvenient for patients, while limiting the geographic scope of enrollment. For more information, visit transparencyls.com/.
Transparency Life Sciences:
BLL Partners, LLC
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SOURCE Transparency Life Sciences