Learn more about us and the work we do.

We’ve assembled a host of great learning tools, including a blog from our team, information from industry experts, webinars, press, and frequently asked questions, all oriented towards helping you understand Expanded Access and the various ways our technology makes the process of getting pre-approval medicine to patients faster, easier, and more valuable.

Explore hot topics in Expanded Access Programs. Our blogs are tailored for biopharma professionals, regulatory specialists, and healthcare advocates.

Enhance your Expanded Access initiatives with our Knowledge Center written by industry experts. Get guidance on Expanded Access and Compassionate Use programs.

  • 5 Reasons to Buy Expanded Access software vs  building in-house. Access Here

  • How MedaSystems’ software platform powers Early Access and Compassionate Use Programs. Access Here

  • Where compassion meets compliance. Regulatory policies and foundations for U.S. Expanded Access Programs. Access here

  • Comprehensive guide to expanded access program success. Create and implement a USA program. Access here

Access expert-led webinars to explore the evolving landscape of Expanded Access and Compassionate Use programs.

  • Experience the new MedaReg in action.

    Your AI-powered ally in researching Regulatory Compliance for Expanded Access Programs

    In just 20 minutes, discover how MedaReg:
    ✅ Simplifies complex regulations
    ✅ Delivers instant answers to your questions
    ✅ Drafts essential documents with ease

    Watch the Demo and Get Access

  • This recorded webinar covers the promise (and potential pitfalls) of Generative AI tools for understanding and navigating regulatory requirements for Expanded Access. Watch the webinar.

Access Our Latest News

  • MENLO PARK, Calif.--(BUSINESS WIRE)--MedaSystems, the leading SaaS platform for Expanded Access (EA) and Investigator-Initiated Studies (IIS), announced a significant new product release » Read More

  • 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 » Read More

  • Brian Irwin Joins as CEO and Board Member, Bringing Decades of Life Science Expertise and a Vision for SaaS Innovation in Healthcare Technology » Read more

Security and Privacy Resources

We’ve built our platform from the ground up with the highest industry standards for privacy and security in mind. Our security program and document management aligns with the leading global security standards, including ISO 27001, SOC 2, FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. We’ve received SOC 2, Type II, HIPAA Compliance and GDPR certification. For a complete overview of our policies and practices, please visit our Trust Center.

FAQs

  • Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. To learn more, read the FDA overview.

  • Because the platform consists of flexible workflow and form creation tools, it can be configured to run many types of programs for requests for investigational medicine, from Expanded or Managed Access Programs, single patient requests, intermediate or treatment protocols, Post-Trial Access programs, Investigator Initiated Studies.

  • We are a cloud based SaaS solution, so it is accessible anywhere in the world with access to the internet.

  • We offer a validated version of our platform and enable the easy creation of forms to support data capture. Please contact us to discuss further.

  • Our solution is delivered as an annual subscription based on the the number of users and platform specific requirements. There is also a 1 time implementation fee. You can contact our customer team to discuss in more detail.

  • There are several resources available to locate Expanded Access programs. We recommend consulting the following websites:

  • There are several excellent resorce guides available to explain Expanded Access for patient., physicians and pharmaceutical manufacturers. We recommend the following as good staring points: