March 05, 2025 12:35 PM Eastern Standard Time

MENLO PARK, Calif.–(BUSINESS WIRE)–MedaSystems, the leading SaaS platform for Expanded Access (EA) and Investigator-Initiated Studies (IIS), today announced additional funding from existing investors, Debiopharm Innovation Fund, Nina Capital, and Young Sohn, a co-founder of Veeva Systems. This investment underscores confidence in MedaSystems’ ability to modernize pre-approval access pathways through its AI-driven workflow platform. By streamlining Expanded Access and IIS workflows, MedaSystems helps pharmaceutical companies and healthcare providers efficiently manage requests, improve patient access, and capture real-world data (RWD) to support evidence generation and regulatory submissions.

“This investment fuels the advancement of new platform capabilities in support of our life sciences partners’ mission to deliver pre-approval treatments efficiently. Expanded Access programs, in the form of compassionate use and physician-led studies, are emerging sources of critical real-world data and directly support drug development and label expansion.”Post this

“This funding reflects the growing industry need for cloud-powered solutions that solve a historically manual challenge in Expanded Access and Investigator-Initiated Studies. With advances in AI and automation, our platform is poised to streamline other domain-critical workflows in life sciences,” said Brian Irwin, CEO of MedaSystems. “This investment fuels the advancement of new platform capabilities in support of our life sciences partners’ mission to deliver pre-approval treatments efficiently. Expanded Access programs, in the form of compassionate use and physician-led studies, are emerging sources of critical real-world data and directly support drug development and label expansion.”

MedaSystems’ SaaS platform automates and streamlines Expanded Access and Investigator-Initiated Study processes, enabling faster responses to treatment inquiries and enhancing real-world data capture for regulatory submissions. The platform provides a centralized hub for healthcare providers, pharmaceutical companies, and regulatory partners to collaborate seamlessly. Physicians can efficiently manage patient requests in-app, working alongside their teams and pharmacists, while life sciences companies can integrate external partners, such as contract research organizations (CROs), to ensure coordinated communication, workflow automation, and expedited treatment delivery.

“I believe in the power of health technology to improve patient outcomes and streamline operational processes for both health system providers and life science companies,” said Young Sohn, Board Director. “MedaSystems is delivering speed and efficiency to this paradigm through its platform, the first of its kind in life sciences.”

About MedaSystems

MedaSystems is the leading developer of software for managing requests for experimental therapies, supporting Expanded Access, Post-Trial Access, and Investigator-Initiated Studies. Its secure, GxP-compliant application serves as a centralized environment that connects physicians and pharmaceutical companies, facilitating global patient access to investigational therapies. By enabling seamless tracking, inquiry management, and data collection, MedaSystems transforms communication between clinicians and life sciences teams, significantly reducing administrative burden and improving collaboration.

* About Expanded Access: Expanded Access (also known as Managed Access or Compassionate Use) allows patients with a serious or life-threatening condition, who have exhausted the standard of care and are not eligible to participate in clinical trials, to request access to investigational therapies that have not yet gained authorization from local regulatory authorities. Read more here.

For more information, please visit www.medasystems.com

Contacts

Aimee Caton
(650) 515-1295

(c)2025 Business Wire, Inc., All rights reserved.