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.

Featured Articles

White papers

  • The 21st Century Cures Act outlines requirements for posting your Expanded Access Policy on your website. We provide a comprehensive overview of the requirements in “U.S. Regulatory Requirements for Expanded Access Policies.” Request the paper

  • Preparing for Expanded Access early in your clinical development process will ensure a smooth launch. Our free white paper, entitled “Expanded Access in the United States: Planning and Management Considerations,” covers the documentation and processes you’ll want in place in order to receive and process requests for Early or Expanded Access. Request the paper

Webinars

  • 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.

News about MedaSystems

Recent Press releases

  • MENLO PARK, Calif. & LAUSANNE, Switzerland--(BUSINESS WIRE)--MedaSystems, a pioneer in software to provide access to pre-approval medicine, is pleased to announce additional funding from Debiopharm Innovation Fund, the strategic investment arm of Swiss biopharmaceutical company Debiopharm, motivated by their vision of patient centric, data-enabled clinical research and enabling patients to access novel treatments sooner.

  • MENLO PARK, Calif.--(BUSINESS WIRE)--MedaSystems, developer of the only purpose-built pharma-physician network to provide patients with access to pre-approval medicine*, today announced the completion of a seed funding round. Participants in the round include a mix of strategic angel and health tech venture investors, with prior track records of founding and funding successful SaaS health companies, including Young Sohn, a founder of Veeva Systems, Vlocity, and Nomadic Systems; nina.capital, a specialist healthtech venture capital fund based in Barcelona; and members of the management team.

  • MENLO PARK, Calif., March 15, 2022 /PRNewswire— MedaSystems, a digital health software company, is excited to announce the completion of a $1.5 million pre-seed funding round led by specialist healthtech venture capital fund nina capital in conjunction with a group of strategic angel investors.

News

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: