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A molecule takes a decade and a fortune to reach approval, and the file describing it fits on a memory stick. We defend trial integrity, formulation IP and validated manufacturing systems without breaking GxP.
Verify that no Phase III efficacy record has been modified outside the validated pathway.
Reviewed 41,208 records: all writes signed, timestamped and attributable. 1 unvalidated export attempt from a CRO endpoint blocked at the boundary.
Security that satisfies a cyber auditor and a GxP inspector at the same time — because in this sector a control that breaks validation is not a control you can keep.
Discovery rarely happens in one building. Formulation data moves between research sites, CROs, contract manufacturers and regulators, and it is valuable at every stop.
Formulation and trial data represent the entire value of a programme, which makes the sector a standing target for state-level actors.
CROs, academic collaborators and contract manufacturers need deep access and run security postures you do not control.
Each compound programme runs in its own segmented enclave, so a compromise at one partner cannot reach an unrelated pipeline.
Bulk movement of formulation and trial datasets is gated and recorded, so exfiltration looks different from ordinary collaboration.
A GxP-validated system cannot simply be patched on a Tuesday. We work inside the change control your quality function already runs.
Every change to a validated system carries a qualification burden, so known vulnerabilities stay open far longer than elsewhere.
An intrusion into batch or environmental control is a patient safety event, not just a data incident.
Where a system cannot be patched, we isolate it and monitor the boundary, documenting the rationale in a form inspectors accept.
Security changes enter the same qualification workflow as any other change, so the estate stays validated and stays current.
How we secure research, trials and validated manufacturing without putting your GxP position at risk.
Catalogue research data, validated systems and every partner holding either.
Segment by compound programme so one partner breach cannot reach the pipeline.
Route every control through qualification so validation status is never at risk.
Hold continuous evidence for both cyber auditors and regulatory inspectors.
No, because they go through the same qualification route as any other change. Where a system genuinely cannot be touched, we do not force it — we isolate it, monitor the boundary and document the compensating control in the form an inspector expects to read.
We stop trying to change their estate and change the boundary instead. The CRO works inside a programme enclave you own, with scoped access and controlled egress, so their posture stops being your exposure without renegotiating the contract.
Our engineers will review your research estate, validated systems and partner boundaries, and outline a 90-day plan that keeps your GxP position intact.
