Beyond FTP and SharePoint: Regulated Data Exchange Purpose-Built for Biotech

Your most important data is often created outside your company. Helyx Data gives biotech sponsors one governed way to exchange it with CROs, CDMOs, labs, clinical sites, and other partners without adding external users to internal systems or downloading regulated files into unmanaged folders.

The session

Your teams already exchange clinical, manufacturing, quality, and patient data with external partners. The files arrive — but through FTP sites, SharePoint, email, partner portals, and shared drives that were not designed for regulated, cross-company workflows.

As a result, business teams become the integration layer. They download files, move them between systems, track versions manually, and store copies wherever the work can continue.

The transfer happened. Sponsor control did not.

This session will show what regulated data exchange looks like when it is designed for biotech. With Helyx Data, CROs, CDMOs, labs, clinical sites, and other partners exchange information through one governed route. Access is controlled, activity is traceable, and teams can see what was received, where it came from, who accessed it, and what happened next.

Partners can use identities they already have, without being added as internal users or requiring another external license. Clinical Operations, CMC, Quality, IT, and Security gain one shared record instead of another disconnected folder.

We'll demonstrate Helyx Data using real biotech workflows — not a generic file-sharing presentation.

What you'll leave with

• Why secure tools can still create an uncontrolled end-to-end process
• The difference between transferring a file and maintaining regulated chain of custody
• How to reduce manual downloads, duplicate copies, and version confusion
• How external partners can exchange data without internal-account or license sprawl
• How to create a traceable route for clinical, manufacturing, quality, regulatory, and research data
• What a pre-validated environment supporting 21 CFR Part 11 requirements looks like in practice
• How governed data exchange improves sponsor oversight, inspection readiness, and AI readiness
• A live demonstration of Helyx Data

Who should be in the room

CEOs, COOs, and leaders across Clinical Operations, CMC and Manufacturing, Quality, IT, Security, Regulatory, Data and AI, and Vendor Management at biotech and life sciences companies. If an external partner creates, holds, or sends data your company is ultimately responsible for, this session is for you.