Clinical Trials
(Phase I–III)
CyberGXP helps sponsors and trial partners secure clinical trial environments while maintaining trial continuity, data integrity, and regulatory confidence.
Clinical trials represent one of the most cyber-sensitive and highly scrutinised stages of the pharmaceutical and healthcare lifecycle.
As products move through Phase I, II, and III trials, organisations begin handling large volumes of sensitive patient data, trial protocols, and regulated records across multiple systems, partners, and geographies.
Cyber risk at this stage is no longer theoretical. A security failure during clinical trials can compromise patient safety, invalidate data, delay regulatory approval, and expose organisations to significant regulatory action.
What You’re Protecting
During Clinical Trials
Trial environments are inherently distributed and collaborative, increasing both complexity and risk.
Key assets include:
Patient data and personal health information (PHI)
Clinical trial management systems (CTMS)
Electronic data capture (EDC) platforms
Trial protocols and study documentation
Investigator and site access systems
Data shared between sponsors, CROs, and research sites
Each additional system, user, and third party expands the attack surface and regulatory exposure.
Cyber Risks Across
Phase I–III Trials
As trials progress, cyber risk grows in both scale and impact.
Common risks include:
Unauthorised access to patient or trial data
Inconsistent access controls across trial partners
Data integrity failures affecting trial outcomes
Ransomware or availability issues disrupting trial continuity
Third-party and CRO cyber risk
Poor audit trails and insufficient logging
Any of these issues can trigger regulatory findings, protocol deviations, or trial delays.
How CyberGXP Secures Clinical Trial Environments
Our approach is built for regulated, multi-party clinical operations.
CyberGXP supports clinical trials through:
Clinical trial cyber risk assessments
Secure access and identity management for sponsors, CROs, and sites
Assurance of CTMS and EDC platforms
Third-party and CRO cyber risk management
Logging, monitoring, and audit trail assurance
Trial continuity and incident readiness planning
We focus on controls that protect trials without slowing delivery or increasing operational burden.
Regulatory & Compliance Expectations
Clinical trial systems and data are subject to strict regulatory and ethical requirements. Regulators expect organisations to demonstrate control, traceability, and integrity across all trial phases.
CyberGXP supports alignment with:
GCP and GxP expectations
Data integrity principles (ALCOA+)
Annex 11 and 21 CFR Part 11 (where applicable)
Privacy and patient data protection requirements
Audit and inspection readiness
Cyber security must support compliance — not sit alongside it.
Supporting Trial Continuity & Approval Timelines
Clinical trial delays are costly — financially, operationally, and strategically. Cyber incidents that disrupt trials or undermine data integrity can directly impact approval timelines.
CyberGXP helps organisations reduce the likelihood of cyber-related trial disruption while strengthening their regulatory position ahead of submission.
Preparing for Regulatory Submission
Decisions made during Phase I–III trials directly affect the quality, integrity, and defensibility of regulatory submissions. Secure, well-governed trial environments make the transition into regulatory review smoother and more predictable.
Cyber security should evolve with the trial — not be retrofitted under pressure.
Protect Trial Data.
Maintain Momentum.
If you’re running or supporting clinical trials and need to protect patient data, ensure trial continuity, and meet regulatory expectations, speak to CyberGXP. We’ll help you secure your trials today — and protect tomorrow’s approval.