Skip to content
Biopharma
Biopharma organizations operate on a fragile pipeline where scientific progress, regulatory rigor, and operational execution are tightly coupled. From discovery through commercialization, the integrity of data, systems, and processes directly influences timelines, outcomes, and trust. Cybersecurity is no longer a technical layer, it is part of how the pipeline holds together.
Overview
Protecting the Pipeline: Cybersecurity Best Practices Across R&D, Clinical Trials, and Manufacturing
In biopharma, the pipeline represents years of scientific discovery, significant investment, and future patient impact. From early research through clinical trials and manufacturing, every stage depends on the integrity and availability of data and systems facing increasing cyber risk. A failure at any point can delay development, compromise trial outcomes, disrupt production, trigger regulatory penalties, or erode partner trust.
Security leaders must balance the need for speed and flexibility in R&D, manage complex clinical trial ecosystems, and safeguard highly sensitive manufacturing environments. Effective cybersecurity programs are designed around how science is conducted and how products move from lab to market, continuously adapt to shifting organizational priorities, and protect the organization from cyber threats.
This paper outlines practical cybersecurity best practices across R&D, clinical trials, and manufacturing, with a focus on protecting the pipeline without slowing innovation. It is written for CISOs, security leaders, and practitioners tasked with translating cyber risk into tangible business and scientific impact, and building programs that support, rather than hinder, the mission of biopharma.
Key Statistics
Multiple threat reports identify manufacturing as the most targeted industry for ransomware attacks in 2024, with industrial organizations bearing a disproportionate share of incidents.
Among top global pharma firms, over 4.5 million records were exposed through thousands of breaches and leaks tracked historically, and 58% of sampled executives had corporate credentials exposed via third‑party breaches.
Supply chain and third‑party risks are significant, examples in healthcare show 72% of breaches originate with third parties, underscoring why CRO/CMO security is critical for biopharma ecosystems
One industry analysis cited that 75% of Abbreviated New Drug Application (ANDA) delays in 2024 stemmed from documentation problems, which include data integrity and compliance issues, not just clinical findings. While not strictly limited to cybersecurity, it highlights the broader compliance risk portfolio that includes cybersecurity data practices.
Insight: Missing or poor compliance documentation, data integrity, audit trails, security records can trigger Complete Response Letters (CRLs), stopping regulatory progress until corrected.
Frames & Compliance
FDA 21 CFR Part 11
electronic records and signatures
ISO 27001 / 27701
information security and privacy management
cGMP (21 CFR Parts 210/211)
manufacturing controls and audit trails
NIST CSF / COBIT
IT and OT risk management frameworks
ICH E6(R3)
clinical trial data integrity and traceability
GxP data integrity (ALCOA+)
auditability, accuracy, and compliance
HIPAA / GDPR
patient data protection and privacy
FDA & MHRA cybersecurity guidance
pre- and post-market security requirements
Biopharma Stack
How Risk Accumulates Across the Biopharma Lifecycle — From Discovery to market
DISCOVERY & PRECLINICAL
target id identification
LEAD SELECTION
drug candidate
early labs systems
ATTACK VECTORS
- IP leakage via SaaS sharing
- Unmanaged researcher devices
- Weak access controls
- Shadow IT tools
Regulatory preparation
(ind / CTA)
DOCUMENTATION SYSTEMS
DATA REPOSITORIES
REGULATION WORKFLOWS
EXTERNAL CONSULTANTS
ATTACK VECTORS
- Poor audit trails
- Excessive access to sensitive files
- Inconsistent documentation controls
- Third-party overexposure
Clinical environment
(phase 1-3)
CRO Platforms
eTMF systems
clinical data systems
partner integrations
ATTACK VECTORS
- Vendor credential compromise
- Third-party access sprawl
- Limited activity monitoring
- Data integrity gaps
SUBMISSION & APPROVAL
(nda / bla / maa)
submission systems
qa / qc review
regulatory correspondence
validation evidence
ATTACK VECTORS
- Unauthorized data changes
- Missing traceability
- Gaps in validation evidence
- Weak change controls
COMMERCIAL & OPERATIONAL
environment
Manufacturing systems
Quality Systems
Pharmo-covigilance
commercial platforms
ATTACK VECTORS
- Manufacturing Systems
- Quality Systems
- Pharmacovigilance
- Commercial Platforms
Our Solution
How Armature Systems Can Help
Cybersecurity Program Development
Designing and maturing security programs aligned to the organization’s lifecycle stage, regulatory expectations, and operational realities.
Security Architecture & Engineering
Defining identity, access, segmentation, and data protection approaches that reflect how research, clinical, and manufacturing systems actually operate.
Solution Integration / Deployment
Implementing and operationalizing security technologies across cloud, SaaS, endpoints, identity, and network environments to improve visibility and control.
Network Engineering
Designing and maintaining network architectures and segmentation strategies that protect sensitive environments without disrupting scientific or operational workflows.
Automation & SOAR
Reducing manual effort and response time by automating detection, response, and operational security workflows.
Managed Services
Ongoing operational support for security technologies and controls, helping teams maintain stability, consistency, and reliability over time.
Managed Detection & Response (MDR)
Continuous monitoring and response across endpoints, identity, cloud, and hybrid environments to detect threats early and contain impact.
Why Armature?
Armature Systems works with numerous biopharma and life sciences organizations across the full lifecycle, from early research through clinical operations and commercialization, including regulated production environments. We are trusted by teams operating in highly regulated, high-stakes settings to navigate complex regulatory, technical, and operational realities. Our approach is grounded in an understanding of how these factors intersect, allowing us to design security programs that protect the pipeline without slowing progress.”