Research labs, clinical-trial sponsors, and specialty manufacturers — IP-rich, FDA-regulated, and squarely in the sights of nation-state actors.
Formulations, trial data, and platform technology represent years of investment and are actively pursued by state-sponsored actors and competitors — theft can occur silently, with no outage to signal it.
Under FDA 21 CFR Part 11 and GxP, electronic records must be attributable, complete, and tamper-evident; an incident that alters or casts doubt on data can jeopardize a submission or trial.
Lab instruments, LIMS, cloud analytics, CROs, and manufacturing systems interconnect across organizations, creating a broad, hard-to-monitor attack surface.
Governs electronic records and electronic signatures, requiring validated systems, audit trails, access controls, and record integrity for FDA-regulated data.
Good practice regulations (GLP/GCP/GMP) and the ALCOA+ principles require that data be attributable, legible, contemporaneous, original, and accurate — and secured against unauthorized change.
Clinical trials and research involving identifiable health information bring HIPAA Security and Privacy Rule obligations for that PHI.
Certain research and dual-use technologies are export-controlled, requiring access restrictions that keep controlled technical data from unauthorized foreign persons — including in cloud and email.
State-sponsored actors quietly exfiltrate research data, formulations, or trial results, erasing competitive advantage and years of R&D with no visible disruption.
Zero Trust access, network segmentation, DLP, encryption, and monitoring for unusual data movement and long-dwell intrusions.
Encryption of LIMS, instruments, or GMP systems halts research and production and can compromise data integrity.
EDR/MDR, immutable backups, lab/OT segmentation, and a tested recovery runbook.
A contract research or manufacturing partner is breached, exposing shared trial data or providing a path into your environment.
Vendor risk reviews, least-privilege partner access with MFA, and continuous monitoring of third-party connections.
MDR, immutable backups, and lab/OT segmentation defend research and manufacturing systems from encryption and extortion.
ExploreTested recovery and validated backup processes protect data integrity and keep trials and production on schedule.
ExploreZero Trust, segmentation, and encryption protect IP and satisfy Part 11 access-control and export-control requirements.
ExploreA named biotech & life sciences engagement story is coming here — the inciting incident, the response, and the outcome.
// CASE STUDIES PUBLISHED WITH CLIENT PERMISSION. REPRESENTATIVE REFERENCES AVAILABLE ON REQUEST.
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