The MedaSystems team reflected on some learnings from the Operationalize Expanded Access Show 2024, from insights into global programs, to the importance of efficiency and oversight, to reflections on the collection of real world data. Read on to learn more.

For many, the question of how to administer Expanded Access Programs (EAPs) often leans towards outsourcing. It's a route frequently taken, perhaps because it seems like the sole feasible option. Collaborating with Contract Research Organizations (CROs) and specialized EAP service providers offers invaluable support, encompassing critical services like logistics, adeptness in country-specific regulations, and proficiency in local languages. While these partnerships effectively tackle challenges, they also come with their set of compromises.

The healthcare sector worldwide is reeling from a severe shortage of vital cancer drugs, including Carboplatin and Cisplatin, cornerstone therapies in various cancer treatments. Companies with alternative treatments in development should consider facilitating access for patients.

According to a recent analysis only 51% of qualified US drug companies appear to be fully compliant with the legal requirements for expanded access visibility. What are the implications for industry, patients, and physicians?

Are you partnering with a Contract Research Organization to deliver an Expanded or Managed Access program? Here are seven ways MedaSystems can help you collaborate more effectively.

This week at MedaSystems we’re thinking about rare disease and how patients can access treatment through Expanded Access. Read this Q&A on the topic from Clinical Trials Arena and learn more about how companies can partner with us to make the process easier and comply with regulatory requirements.

The collection of Real-World Data from Expanded Access treatment is not yet a widespread practice, but it's growing. Regulators are helping to drive this adoption.

Here are six key things needed to set up a simple Expanded Access program in just a few weeks.

In Part 1 of this 3 part series, we discuss the philosophical issues around offering Expanded Access and ethical considerations around such programs.

When healthcare providers (or patients and families) email or upload patient information as part of an Expanded Access request submission into MedaSystems, the platform automatically scans incoming information and highlights any PHI that is found, along with a confidence score. The software will then prompt the pharmaceutical company to accept or overrule suggested redactions, so that any PHI can be scrubbed from requests with just a few mouse clicks.

The most recent version of the MedaSystems software platform for Expanded Access includes new online Forms that enable Expanded Access teams to collect information they may need in order to reach approval decisions more quickly.

Our easily configurable workflow tool creates a checklist to walk each stakeholder through the steps they need to respond to an Expanded Access request. The workflow is configured to conform to your company’s Standard Operating Procedure(s) (SOP) and, combined with the regulatory requirements of the country from which the request originates, will generate a checklist that can be followed by both the internal request manager and the clinician team submitting the request.

The new version of our MedaSystems Expanded Access platform adds workflows, configurable forms and a clinician portal.

What we’re reading: “How far do you go when the alternative is death?” and article by Daniela J. Lamas in the New York Times, tells the story of a patient requesting expanded access.

Our free white paper provides a comprehensive guide to planning your next EAP

An overview of the FDA’s approach to real-world data gathered during Expanded Access