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.
Implementing Expanded Access in Your Organization
We recently had the privilege of hosting an interactive Q&A, "Implementing Expanded Access in Your Organization," featuring a panel of leaders and experts in the field: Paula Singer, Dr. Dennis Brown, Dr. John Langlands, and our Executive Vice President, Matthew Rosen.
Why MedaSystems’ Platform Sets a New Standard in Expanded Access Program Management
Why MedaSystems’ Platform Sets a New Standard in Expanded Access Program Management
CUPA Webinar
At MedaSystems, we believe in utilizing technology to expand hope. That’s why we’re paying close attention to the evolving landscape of pre-approval access, a critical pathway for patients ineligible for clinical trials to access new treatments.
The Hidden Costs of Building EAP Systems In-House
Expanded Access Programs (EAPs) give patients with life-threatening conditions early access to investigational therapies, but they require strict regulatory compliance, collaboration, and data management.
Why Buying Beats Building for EAP Management
Companies managing EAPs must choose between building an in-house solution or buying a specialized platform. While building in-house offers control, it comes with high costs and complexity. The smarter choice is to buy a purpose-built platform.
Should You Build or Buy? The High-Stakes Decision in Expanded Access
MedaSystems, the next-gen software platform for managing Expanded Access programs.
MedaSystems Featured at the Society for Neuro-Oncology (SNO) Annual Meeting
MedaSystems, the next-gen software platform for managing Expanded Access programs, is featured in two scientific research posters at the Society for Neuro-Oncology (SNO) Annual Meeting in Houston, TX
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.