Phlexglobal Selected to Support Rapid, Compliant Investigational New Drug Application for COVID-19 Therapy

Phlexglobal

MALVERN, PA — Phlexglobal, a leading innovative technology and services provider for the life sciences industry, recently announces that Hope Biosciences Stem Cell Research Foundation has selected Phlexglobal’s advanced SaaS solution, PhlexSubmission, to enhance the efficiency and quality of its eCTD submissions process.

As an organization dedicated to advancing research through innovative protocols using the latest technology, the Foundation was looking for the most advanced Electronic Common Technical Document (eCTD) software partner to support its mission. PhlexSubmission – a robust, highly configurable, and easy-to-use publishing engine for electronic submissions such as eCTD, NeeS, and VNeeS – was the clear winner.

“We launched the Foundation this year to accelerate translational research in regenerative medicine so that therapies could be delivered to patients faster, ultimately by delivering high-quality data for quicker approval,” noted Donna Chang, Founder, Hope Biosciences Stem Cell Research Foundation. “With three COVID-19 protocols already approved, our team needed a solution provider to match our dedication to speed and quality, and whose submissions technology could meet our stringent requirements and growing trial portfolio. We found the right partner in Phlexglobal.”

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With its previous eCTD software, the Foundation was faced with a costly and cumbersome “pay-per-submission” model, with each new application requiring a new payment through a cumbersome and time-consuming process. In addition, the eCTD software itself was hard to learn and use, adding time and effort – an unnecessary burden when every hour counts.

When Hope Biosciences Stem Cell Research Foundation evaluated solution providers, Phlexglobal’s PhlexSubmission eCTD software stood out in multiple key areas:

  • Efficiency: The Foundation remarked favorably on the highly intuitive and easy-to-use PhlexSubmission user interface (UI) – complete with Phlexglobal’s unique Virtual Electronic Realtime Assistant (VERA) to help guide users at every step.
  • Quality: PhexSubmission software is fully validated and always in compliance with the latest ICH guidelines, with a proven record supporting more than 4000 successful eCTD submissions for 17000 products to the FDA, EMA, and other agencies and supporting virtually every country.
  • Innovation: By leveraging advanced AI and machine learning technologies, PhlexSubmission streamlines the process by including automation running in the background, as well as the ability to automatically read and classify eCTD documents, extract relevant metadata, and auto-generate an eCTD submission.
  • Cost-Effectiveness: PhexSubmission offers organizations unlimited submissions to an unlimited number of countries at a fixed cost – providing budget predictability, and allowing study teams to spend more time on critical trial tasks instead of administration
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“Phlexglobal is proud to support the important work being done by Hope Biosciences Stem Cell Research Foundation to speed the development of innovative therapies for COVID-19,” said John McNeill, Chief Executive Officer of Phlexglobal. “The Foundation joins more than 16 other research organizations developing COVID-19 vaccines and treatments which we are actively supporting with world-class regulatory compliance software and expert services. On behalf of the entire Phlexglobal team worldwide, we are honored to play a part in fighting the most difficult health crisis of our lifetimes.”

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