MedaSystems Announces Major Platform Update to Help Life Sciences Organizations Govern and Scale Expanded Access Programs

MedaSystems, a SaaS platform for managing Expanded Access, Post-Trial Access and Investigator-Initiated Study programs, announced the release of MedaSystems Version 3.3, one of the company’s most significant platform updates to date.

MedaSystems

The release introduces new capabilities designed to help pharmaceutical and biotechnology organizations manage increasingly complex patient access programs with greater efficiency, consistency and control. Version 3.3 expands MedaSystems’ capabilities across team collaboration, workflow automation, document management, privacy, external HCP governance and administrative configuration.

“As Expanded Access programs grow across therapies, geographies and stakeholders, technology needs to do more than digitize existing processes. It needs to make those processes easier to govern and scale,” said Matt Rosen, CEO of MedaSystems. “Version 3.3 reflects what we keep learning from the organizations running these programs every day, from global companies managing thousands of patients and requests to oncology and rare disease biotechs bringing novel therapies forward. We’re giving teams more flexibility and control while cutting the administrative complexity that stands between them and the patients they are working to support.”

Scaling Collaboration with Reusable Case Teams

One of the most significant additions in Version 3.3 is Case Teams, which enables organizations to create reusable groups and assign them across cases, checklist tasks and automation rules. Tasks can now be routed to an entire Case Team, allowing individual team members to pick up work while keeping the broader team informed.

For organizations operating across multiple products, countries and functions, this provides a more scalable approach to coordinating responsibilities and maintaining consistent workflows.

Greater Control Over Global Program Workflows

Version 3.3 gives administrators additional control over how programs are configured and managed. Organizations can now configure case-closure reasons and determine which countries are available in internal and public intake forms, including automatically declining requests originating from countries that have not been enabled.

A redesigned Automation Tool also makes case-creation logic easier to configure, including the ability to generate case names from intake-form responses and identify potentially conflicting automation rules.

Simplified Document Distribution

New Document Bundles allow related documents to be grouped and released together rather than shared individually. Bundles can also be incorporated directly into workflows so an entire set of documents is automatically released at the appropriate stage of a case. Physicians receive a single summary email for each release rather than separate emails for every document.

Stronger Privacy and HCP Governance

Version 3.3 introduces additional controls over how external HCP users interact with cases. Administrators can prevent physicians from skipping required tasks, lock forms following submission and restrict physicians from deleting forms.

The release also adds an optional in-case redaction capability. Authorized users can permanently remove personal or health information from messages, discussions and form fields without deleting the underlying case or inquiry. The surrounding clinical information and history remain intact, while every redaction is logged without retaining the removed information.

“Version 3.3 is about making sophisticated workflows easier to manage without sacrificing control,” said Jeff Thibeault, CTO of MedaSystems. “We’ve expanded the platform architecture around reusable teams, configurable workflows, privacy controls and auditability while also improving performance across the application. The result is a platform that can support increasingly complex programs while remaining intuitive for the people using it every day.”

Expanded E-Signature and Audit Capabilities

Version 3.3 also adds support for Adobe Sign, giving customers a second 21 CFR Part 11 compliant e-signature option in addition to DocuSign.

Activity histories in Version 3.3 are written for the people who read them. Each entry describes what changed, where it changed and who made the change in plain language, so quality teams, auditors and program leads can follow the record without interpretation. The same clarity applies at the organization level, where changes to users, access and configuration are captured alongside program activity.

A Faster, More Intuitive Experience

Beyond the new functionality, Version 3.3 includes platform-wide performance enhancements, with improvements particularly noticeable when working with long lists and heavily filtered screens.

Case filtering has also been redesigned to help teams find and manage information more efficiently. Enhancements include active-filter indicators, quick filters, saved filter preferences, searchable dropdowns and automatic application of filter changes. For users working across multiple drug companies, additional filtering and safeguards help prevent bulk actions from inadvertently spanning organizations.

About MedaSystems

MedaSystems provides a SaaS platform purpose-built to help life sciences organizations manage Expanded Access, Post-Trial Access and Investigator-Initiated Study programs. The platform centralizes workflows, communications, documentation and program data in a secure environment, helping cross-functional teams streamline operations, strengthen governance and support programs at global scale. MedaSystems is a trusted partner for global organizations that offer managed access, pre-approval access, compassionate use and expanded access programs.

Contact the company, MedaSystems


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