Inside MedaSystems’ Expanded Access Platform—A Live Walkthrough of Configurable, Compliant Managed Access
Meta description (SEO): See how MedaSystems helps sponsors streamline expanded access with configurable intake forms, automated routing, audited workflows, AI-powered PHI redaction, and a simple HCP portal experience.
Introduction
Expanded access (and other managed access programs) often get stuck in the same place: fragmented tools, manual admin work, and limited visibility. In our first webinar of the 2026 MedaSystems series, our team walked through how we’re helping sponsors modernize the end-to-end process—without sacrificing compliance, security, or flexibility.
In this session, Anton White (VP of Growth) introduced MedaSystems’ approach and what we consistently hear from sponsors and providers. Then Dylan Sawchuk (VP of Customer Success) delivered a live demo showing what “configured for your SOP” looks like in a real, production-mirrored environment. Aimee Caton (VP Marketing) moderated Q&A throughout.
Below are the key takeaways and highlights from the webinar.
Why MedaSystems exists: making investigational therapy access simpler and faster
MedaSystems is a cloud-based SaaS platform built to support:
Expanded Access Programs (EAP)
Post-Trial Access
Investigator-Initiated Studies (IIT)
Anton shared the founding principle: there’s been a long-standing gap between patient need and a streamlined, compliant path to investigational therapies. Teams end up juggling email threads, spreadsheets, disconnected systems, and country-specific requirements—while trying to protect sensitive patient data.
What attendees said is most burdensome
In the live poll, participants overwhelmingly selected manual administrative processes as the biggest burden when processing EAP requests—consistent with what our team hears most often.
The platform foundation: configurable workflows, built for real-world programs
A consistent theme in the webinar was configurability.
Instead of providing a rigid “off-the-shelf” system, MedaSystems configures:
Intake forms to capture the right information upfront
Workflows/checklists to match your SOPs
Dashboards and reporting for the visibility your stakeholders need
The goal: reduce back-and-forth, remove bottlenecks, and make every case trackable from intake to supply.
Security & compliance: designed for regulated environments
Anton also emphasized MedaSystems’ security posture and compliance readiness, including:
GxP-ready practices
FDA validation (supporting customers who capture data in the system)
SOC 2 certification
GDPR compliance
Encryption and secure storage (AWS data centers), plus vulnerability scanning, access restrictions, SSO/MFA options, and contingency planning
The consistent message: accelerating access only matters if the data and process are protected at every step.
Live demo recap: the end-to-end experience in two personas
Dylan ran the demo as a fictional sponsor and walked through two perspectives:
HCP (health care provider) submitting a request
Sponsor admin/approver receiving, triaging, processing, and collaborating on the case
1) A better front door than an inbox: branded portal intake
Instead of sending requests to an email address, the HCP starts on a sponsor-branded portal experience:
The portal can be branded (colors/look & feel)
Roles can be configured (e.g., HCP-only, patient info view, etc.)
Intake begins with country + product selection, and then launches a tailored intake form
Localization in action
Dylan showed the same product request from two countries:
Taiwan (intake form displayed in Chinese)
Afghanistan (intake form displayed in English)
This highlighted a key capability: language and workflow localization can vary by country/program.
2) Inquiry vs. case: triage before you commit a workflow
On the sponsor side, the platform distinguishes between:
Inquiries: requests that need triage
Cases: requests that are actively in a defined program/workflow
Why this matters: not every request should automatically become a “case.” You may want to track demand, ask clarifying questions, or quickly reject without spinning up a full workflow path.
3) Automated routing: the right request goes to the right team
The missing Taiwan request on the admin’s dashboard wasn’t a bug—it was routing logic.
Dylan demonstrated how requests can be:
Auto-converted into cases
Auto-assigned to the correct regional/program team member
Named and categorized automatically
This is especially useful for global teams or large programs where queue monitoring becomes a bottleneck.
What powers execution: teams, tasks, and auditable checklists
Case teams with role-based permissions
Sponsors can build a case team by adding internal members and assigning roles (e.g., medical reviewer). Permissions are highly configurable:
Some organizations allow broad collaboration
Others lock down admin actions to IT/system administrators
The point: you can support both flexible and highly controlled operating models.
SOPs become checklists
The heart of the platform is the checklist, where each step is tracked as a task:
Form tasks (data entry)
Document upload tasks
Signature workflows (e.g., DocuSign)
Reminders and due dates
Task assignment and delegation
Dylan demonstrated a regulatory framework form, submission, and how completion immediately shows in the workflow.
Audit logs: full traceability without the scramble
Every action is captured in an audit log—helpful for:
Internal reviews
Compliance audits
Reconstructing decision paths (who did what, when)
As Anton noted, the value of auditability often becomes crystal clear the moment an audit begins.
Collaboration that’s actually case-native (and auditable)
Instead of splitting conversations across Slack, email, and spreadsheets, the platform centralizes collaboration with:
Internal discussion (sponsor-only chat)
Public discussion (sponsor ↔ HCP chat)
Logged email communications tied directly to the case
This supports quick decisions at branching points (e.g., selecting a regulatory framework) while keeping the record complete.
HCP experience: simple, secure, and minimal training required
When the HCP is invited into a case, the workflow becomes straightforward:
Login with two-factor authentication
HCP sees their dashboard with only their open tasks
HCP fills out assigned forms and submits
HCP can create their own team (e.g., nurse/pharmacist) and delegate tasks
In Q&A, Dylan shared an important adoption insight: most HCP support requests are password-related—not “how do I use this?”—because the workflow is designed to guide the user step-by-step.
AI + automation: speeding up operations while reducing risk
The webinar highlighted multiple automation features, including:
Automated reminders
Auto-assignment by country/product/program
Bulk communication
Integrations via API or custom integration patterns
An “AI copilot” navigation concept
AI-powered PHI redaction (with controls)
Dylan demonstrated the PHI redaction capability on an uploaded document:
The system detects potential PHI and shows confidence levels
Thresholds can be adjusted
Redaction can be automated or turned off
Sponsor staff can also redact after the fact (useful for scenarios like import permits where temporary visibility is required)
Q&A highlights
Here are a few questions that came up live:
Is there a limit to users? No—and the business model described does not charge per user.
Can auditors/executives have view-only access? Yes, via role-based access.
Can you auto-confirm inquiry receipt? Yes—automated responses can be configured.
Can the platform support other use cases (IITs, grants, etc.)? Yes—flexible for other collaborative workflows.
Does shipping integrate with internal systems? Yes—via API or built integrations; shipment tracking is structured for reporting.
How does safety reporting work? Safety reporting can link out to the sponsor’s safety platform rather than capturing safety data inside MedaSystems.
Built for faster access, clearer visibility, and lower operational burden
If you’re running managed access through email, spreadsheets, or multiple disconnected systems, the webinar takeaway is simple: a configurable, audited, sponsor-and-HCP-friendly workflow can meaningfully reduce manual overhead and improve cycle times—without compromising compliance.
