What’s New
We share news about new product features, our thoughts on recent developments at MedaSystems or in the industry at large. Scroll down for a chronological view, or jump to posts using the categories to the left.
Takeaways from Operationalize Expanded Access Programs 2024
The MedaSystems team reflected on some learnings from the Operationalize Expanded Access Show 2024, from insights into global programs to the importance of efficiency.
Auto-redact personal information from Expanded Access requests
MedaSystems platform automatically scans incoming information and highlights any PHI found, along with a confidence score. The pharmaceutical company accepts or overrules suggested PHI redactions with just a few mouse clicks.
Expanded Access requests can be a fire drill. We built a workflow tool to help.
Expanded Access request workflows are configured to conform to your company’s Standard Operating Procedure(s) (SOP) and, combined with the regulatory requirements of the country.
To outsource your EAP, or not?
For many, 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.
Investigational Medicine Access Amid the Oncology Drug Shortage
The healthcare sector worldwide is reeling from a severe shortage of vital cancer drugs, including Carboplatin and Cisplatin, cornerstone therapies in various cancer treatments.
Only 51% of US companies are compliant with Expanded Access visibility laws
According to a recent analysis, only 51% of qualified US drug companies appear to comply with the legal requirements for expanded access visibility fully.
Seven ways to collaborate more effectively with your Managed Access partners
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.
What we’re reading: Q&A on the ethics of ultra-rare disease drug development and expanded access
This week at MedaSystems, we’re thinking about rare diseases and how patients can access treatment through Expanded Access. Read this Q&A on the topic from Clinical Trials Arena and
Set up an Expanded Access Program in a few weeks (III)
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.
Set up an Expanded Access Program in a few weeks (II)
Here are six key things needed to set up a simple Expanded Access program in just a few weeks.
Set up an Expanded Access Program in a few weeks (I)
In Part 1 of this 3 part series, we discuss the philosophical issues around offering Expanded Access and ethical considerations around such programs.
The Power of Flexible Forms
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.
MedaSystems V2.0 adds configurability and collaboration
The new version of our MedaSystems Expanded Access platform adds workflows, configurable forms and a clinician portal.
What we’re reading: NYT “How far do you go when the alternative is death?”
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.
Your Expanded Access programs, like everything else in life, will benefit from preparation
Our free white paper provides a comprehensive guide to planning your next EAP.
How does the FDA view expanded access data?
An overview of the FDA’s approach to real-world data gathered during Expanded Access