A Phase III trial moves through a primary CRO, sub-CROs, central labs, imaging vendors, and biomarker labs before it reaches a regulator. At every handoff, the Data Package leaves one environment and enters another. Confidencial embeds persistent governance into the data itself, so chain of custody travels with every file, not just with the systems it passes through.
Every CRO handoff is a chain of custody event that your current stack treats as a file transfer. The sponsor's classification tags become informational. The audit trail ends. By the time the Data Package reaches a sub-CRO or central lab, you have contractual agreements describing what should happen to it and no way to prove what did.
The data most at risk isn't the final submission. Draft INDs, interim analyses, and redlined protocols contain the reasoning and competitive logic that finals have had removed, and they are exactly what a scientist pastes into an AI tool before a deadline.
Your eTMF enforces governance inside Veeva. Purview classifies inside your tenant. NDAs describe what CROs are permitted to do. None of these controls travel with the file. Access and control are not the same thing. When a CRO downloads your Data Package, you have granted access. You have lost control.
A single Phase III trial might move through 8 organizations before it reaches a regulator, each one a hop where your governance ends and risk begins.
Trial data exported from Veeva to the primary CRO. The CRO shares with a sub-CRO. At every hop, your classification tags are informational and your audit trail ends.
A CRO working across multiple sponsors pools your trial data alongside your competitors'. The aggregated model encodes what no sponsor would voluntarily share, and you have no audit trail to detect it.
A scientist uploads a protocol or interim analysis to ChatGPT to tighten language. ePHI, compound structures, and patient identifiers enter a public model the sponsor didn’t sanction.
A Veeva export is not a governance strategy.
The CRO download is where chain of custody ends.
Not the system. Not the perimeter. The file itself — from creation through AI ingestion.
Each product picks up where your existing stack stops. Deploy individually or together across your environment.
Automatically encrypt ePHI, compound structures, and patient identifiers before files leave the sponsor environment. Works at the CRO boundary, with every file that crosses the perimeter is protected before it arrives.
ePHI, compound structures, and interim analyses are protected before they enter any AI pipeline. The model sees what it should. Full audit trail available at any time.
Persistent protection for clinical data stored across cloud environments, such as sponsor systems, CRO infrastructure, central lab platforms. Protection travels with the file regardless of where it’s hosted.
Encrypted file exchange for sponsor-CRO workflows. Every file shared is encrypted client-side, tracked end-to-end, and revocable after it leaves your hands. Chain of custody extends beyond the data room.
Protected data environments for Phase II/III trials, licensing workflows, and regulatory submissions. Every document carries its own access policy. Their breach is not your breach.
The 2026 HIPAA Security Rule makes encryption mandatory, not addressable, and explicitly includes AI software in the technology asset inventory requirement. GxP frameworks require data integrity across the entire third-party network. The FDA expects a chain of custody that sponsors currently cannot produce.
The sponsors that can demonstrate provable, documented protection for their Data Package — with an audit trail across every hop, not a policy document — have a credible answer when a regulator or partner asks what happened to a file.
Yes. Confidencial operates at the content layer, below your eTMF. Veeva Vault works exactly as it does today no workflow changes, no retraining. Encryption is applied when documents are created or shared, and travels with the file into any environment it reaches after export.
Purview classifies data and applies labels inside your Microsoft tenant. Labels can be removed by a CRO outside your tenant. DLP catches accidental leakage — it has no visibility once an authorized user shares an authorized file to an authorized CRO. Confidencial is the layer that activates precisely where both stop: the moment the file leaves your environment.
Protected files return nothing usable to an unauthorized AI process. ePHI, compound structures, and patient identifiers are encrypted before they could reach the model. The protection is cryptographic. It doesn’t depend on scientist awareness or behavior change.
Every access event is logged across every hop, including what AI tools ingested the content. If a CRO aggregates your data across sponsor clients, the audit trail surfaces the access pattern and revocation closes the gap. The sponsor can revoke access at any point, even after the file has changed hands.
GxP data integrity requires ALCOA+ compliance, attributable, legible, contemporaneous, original, and accurate records, across every environment the data touches. Confidencial’s audit trail satisfies this across the entire third-party network, producible on demand.
No. Protection is embedded in the file at the sponsor level before it leaves. CROs work with the files exactly as they do today. The protection is architectural. It doesn’t depend on CRO cooperation, IT infrastructure, or behavior change.
One export. One sub-CRO handoff. One scientist pasting an interim analysis into ChatGPT. That’s all it takes to break chain of custody on a Data Package you spent years building. We’ll show you exactly where your governance stops — in 30 minutes.
Book a session with a solutions consultant30 minutes. No slides. We map your governance gap and show you what’s exposed.