MedaSystems for

Expanded Access

Expanded Access Simplified

A purpose-built Expanded Access solution for pharmaceutical manufacturers.

MedaSystems provides an easy to use, intuitive software that enables collaboration between life sciences teams and physicians.

MedaSystems software for expanded access
Computer with checklist for expanded access or managed access

A central repository for cases

An easy to use portal allows physicians and their patients to submit, track and manage requests, communicate with the clinical team, create forms and report on activity.

Expanded access or managed access dashboard

Data capture

Understand the origins, processing and decision making around requests. Collect and track real world data to understand the performance of therapies in patients. Easily upload and export data to and from the system.

Expanded access software inquiry form

Collaboration

Invite healthcare providers into the system to provide the information required to process a request. Email templates allow rapid standardized responses to patient and physician inquiries. Add an inquiry form to your website to standardize data capture.

  • Flexibility

    Users can design their own workflow, communication, checklists and reports, so the system fits the needs of their geographies, regulations and processes.

  • Simplicity

    An intuitive user interface ensures staff can easily communicate, locate and audit information.

  • Visibility

    Document, track and report on requests by geography, institution, or physician.

  • Compliance

    Ensure processes are in compliance with local regulatory guidelines. Easily locate and audit information.

  • Speed

    Accelerate the time to evaluate requests for patient access to experimental therapies.

  • Tracking

    Keep track of all the communication and documentation around each patient case.

What People Are Saying

“MedaSystems has transformed our process and has reduced our turn times to make a decision on an inquiry from 4 days down to 1. The platform makes it much easier for us to process and track requests. It is now our operating system for expanded access.”

— Chief Scientific Officer

“The MedaSystems platform helps us process cases in days rather than weeks or months. We can collect data and quickly make decisions, even while team members are out of the office.”

— Senior Request Manager

Manage intermediate-sized patient populations programs

Real world data capture form for expanded access

Patient management

Track medical history, treatment plans, enrollment, and consent.

Real-world data capture

Leverage treatment data to surface insights into drug safety and efficacy to support regulatory submissions and future research.

FDA & EMA compliance

Meet regulatory and ethical obligations regarding patient selection, enrollment, and treatment.

Communication

Healthcare Providers can report treatment progress and adverse events to sponsors in a structured manner triggering all necessary alerts.

Considering offering Expanded Access?

Checklist for expanded access process

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.

Interested in learning more?

Check out some of our great resources for learning more about Expanded Access and Compassionate Use, the application of technology to make it easier to provide access to patients, and our approach to both.