Market Overview

Phesi Files Patent for Proprietary Method and System for Developing Clinical Trial Protocols


Technology specifically designed to develop and/or optimize trial
eligibility criteria

Phesi, a data-driven provider of premier clinical development services,
today announced it has filed a patent for its proprietary method and
system for developing feasible clinical trial protocols. The patent
application, #2549-PRO, filed with the United States Patent and
Trademark Office (USPTO), specifically covers Phesi's technology for
developing and/or optimizing a protocol's inclusion/exclusion criteria,
based on quantitative analysis of historical data.

Phesi's patent application pertains to a method and system to expedite
development of final criteria for a clinical protocol with reliable high
quality and consistent objectivity. The method and system are designed
to align the trial objective with a quantitative analysis of potential

"Clinical trials are the workhorses of the pharmaceutical industry, the
basis of the safe and effective use of new therapies," said Gen Li, PhD,
MBA, founder and chief executive officer of Phesi. "However, many
clinical trials take longer than expected because of patient enrollment
difficulties, which often result from suboptimal protocol design. This
patent application covers an invention that provides a technical
solution for designing a feasible protocol based on a targeted patient
population. Our intellectual property yields valuable insights not only
from successful clinical trials, but also from failed ones, including
numerous high-profile failures."

The USPTO has assigned the U.S. Serial Number 62/716,019 to Phesi's
patent application, which reflects the Company's approach to data-driven
drug development. Phesi's approach utilizes millions of automated,
dynamic, and real-time data sources to generate accurate and reliable
insights. It enables faster patient enrollment and trial completion by
facilitating assessment of competitive trial sites and identifying
optimal sites. Additionally, by enabling relevant and accurate protocol
design, Phesi's approach heightens chances of trial success and
optimizes the path toward regulatory approval.

More About Phesi

Founded in 2007 as Pharmaceutical Pipeline Enhancement Strategies, Phesi
is a dynamic, data-driven drug development company, providing
comprehensive clinical development services for life sciences companies
around the world. Phesi's integrated service offerings cover the entire
clinical development process: from development planning and indication
assessment to protocol evaluation, site selection, and trial
implementation management.

Phesi has the industry's most comprehensive and dynamic clinical trials
database and predictive analytics tools, including 213,000
interventional, randomized clinical trials, 604,000 completed clinical
research projects, and over 1.6 million investigator records from
multicenter interventional clinical trials.

The leadership team at Phesi is driving the future of pharmaceutical
R&D, offering unique perspectives on the optimal role of digital
technology, the importance of building service organizations around new
technology, and an overall understanding of the transformation that
needs to happen to improve clinical development.

For more information please visit
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