Study access
Coordinate joiner, mover and leaver access across EDC, CTMS, eTMF and collaboration systems.
Healthcare & clinical research
Cybersecurity for clinical research organizations.
Protect study operations, sensitive information and trustworthy electronic records across research sites, sponsors and service providers. Connect technical controls to defined responsibilities and reviewable evidence.
Record integrity
Scope audit trails, privileged changes, exports and review responsibilities for important study records.
Third-party boundaries
Understand what sponsors, sites, CROs and technology vendors each control and what evidence they provide.
Begin with the records and your role.
A CRO, research site and research technology vendor can have different obligations. Map the study workflows, record types, sponsor contracts and systems before selecting controls. Not every clinical research organization is automatically a HIPAA covered entity or business associate.
Electronic records · scope dependent
21 CFR Part 11
Part 11 applicability depends on the electronic records and applicable FDA requirements. Evaluate scope and the relevant predicate rules with your regulatory and quality team. Do not treat a security tool as proof that a system or study is Part 11 compliant.
FDA guidance · recommendations
Trustworthy electronic systems
FDA’s October 2024 final guidance addresses electronic systems, records and signatures in clinical investigations, including security, audit trails, service providers and risk-based validation. Guidance explains FDA’s recommendations; it is distinct from binding regulations.
Health information · role dependent
HIPAA and research data
Assess whether HIPAA applies to your role and information. Research use or disclosure of PHI can involve authorization or another permitted basis, with privacy decisions handled by the appropriate institutional and legal teams.
Contracts & quality oversight
Sponsor and vendor responsibilities
Review agreements for access, incident reporting, retention, recovery and evidence requests. Align cybersecurity work with your quality and validation processes so that technical changes are appropriately approved.
Controls to scope for the research workflow
Technical implementation
- MFA, role-based access and privileged-account controls.
- Managed endpoints, patching and encryption.
- Approved data transfer, sharing and export controls.
- Logging, audit-trail availability and review ownership.
- Backup, recovery testing and secure configuration.
Governance & evidence
- System inventories and data-flow responsibilities.
- Vendor assessment and contract follow-up.
- Change approval and exception records.
- Incident escalation across sponsors, sites and providers.
- Access-review records and dated test evidence.
These are scoping priorities, not a universal regulatory checklist. Validation, electronic signatures and study-specific requirements must be addressed within the appropriate quality and regulatory scope.
From study risk to verified controls.
01 · Identify
Map systems, business risks and applicable requirements.
02 · Implement
Deploy agreed controls and assign remediation owners.
03 · Prove
Record dated evidence, coverage and exceptions.
04 · Verify
Retest controls and review changes on an agreed cadence.
CyberGuard supports agreed technical controls; Cyber Compliance organizes requirement mapping and evidence; Virtual CISO coordinates security governance. NCB Cyber does not claim FDA certification or guarantee inspection outcomes.
Return to the healthcare security hub · Explore medical billing security
Primary sources reviewed September 11, 2026. Confirm the requirements for your studies, records and jurisdiction with your regulatory and privacy advisers.
Start with a Cybersecurity Control Review.
Discuss your environment, the controls you rely on and the evidence you need. We will agree the scope before any technical assessment or system access.