Newsletter

As biotech companies deepen their reliance on digital infrastructure and third-party vendors, managing cybersecurity risk has become significantly more complex.  According to the World Economic Forum (Global Cybersecurity Outlook 2025), 54% of large organizations identified supply chain challenges as the biggest barrier to achieving cyber resilience, citing limited visibility into third-party security and the growing risk of software vulnerabilities introduced by external vendors. In this landscape, a proactive risk management strategy encapsulating the entire range of threats facing data integrity becomes the only path to strong cybersecurity. 

In cybersecurity, effective risk management begins with identifying, assessing, and prioritizing potential threats to an organization’s IT assets.  The primary focus is on evaluating each risk element individually, allowing for informed decisions about how best to protect sensitive systems and data through the lens of impact, likelihood, and detectability: 

• Impact – What effect would this risk have on the organization’s operations, intellectual property, or patient data if realized? 
• Likelihood – How probable is it that the risk will occur, based on historical events, threat intelligence, or industry trends? 
• Detectability – How quickly and effectively could the organization detect and respond to the threat? 

This approach allows biotech companies to make data-driven decisions and optimize the implementation of security controls. Keeping and maintaining this data will support biotech companies in their efforts in audit preparedness as well as help build stakeholder and customer confidence. 

Once internal risks are assessed, the IT supply chain requires a critical eye.  A recent report by Proofpoint and Ponemon (Cyber Insecurity in Healthcare: The Cost and Impact on Patient Safety and Care 2024) points to 68% of the 648 institutions surveyed had experienced an attack against their supply chains which often led to heavily disrupted operations and patient care. When third party security fails, it can compromise trial integrity, regulatory submissions, or even patient safety.  This makes it vital to understand how external vendors handle sensitive information.  Reviewing and vetting vendor’s methods for handling sensitive data is imperative to ensure that compliance is maintained even as data like patient records, clinical trials, and IP pass through multiple platforms and data stewards.   

While assessing vendors and establishing a risk management program can feel overwhelming, life science organizations of all sizes find significant benefits through this effort. A structured third-party risk management process enables organizations to: 

• Evaluate and compare vendors 
  • Select partners who meet specific security and compliance standards 
• Validate ongoing vendor practices 
  • Ensure that current vendors are handling sensitive data in a secure and compliant manner 
• Track and adapt to changes 
  • Monitor changes in the cybersecurity environment over time and adapt accordingly, allowing new projects to be prioritized and implemented in alignment with evolving risks and organizational needs 
• Support regulatory compliance 
  • Maintain alignment with industry regulations such as those enforced by the FDA, EMA, or HIPAA, reducing audit risk and reinforcing trust with stakeholders 

Creating a third-party risk assessment program requires a holistic understanding of how data is shared with vendors and the potential impact a breach of sensitive data could have on an organization. NIST Special Publication (SP) 800-161 (https://csrc.nist.gov/pubs/sp/800/161/r1/final) provides a comprehensive framework for how private sector companies should manage cybersecurity risks associated with their supply chain, including cloud vendors, contractors, and other third-party vendors.  This process requires the consideration of, what experts refer to as, the CIA (confidentiality, integrity, and availability) of systems and data that arise through the supply chain.  Assessing each vendor’s capabilities and processes for elements of security like access management, data privacy, and infrastructure or operations management procedures is key to managing the cybersecurity risks that they could present to shared data. 

How Celito Can Help: 

At Celito, we recognize the urgent need for maintaining data integrity inside and outside of an organization.  We tailor cybersecurity risk management solutions to each organization’s unique environment by building custom risk registers and vendor assessment forms to record, manage, and track current and future challenges faced. Our risk management program helps guide organizations through the procedural and practical elements of accounting for and maintaining risk registers and 3rd party vendor assessments to ensure that your IP, records, trial results, and other sensitive data remains secure and accounted for to ensure full regulatory compliance.  We help create repeatable processes for documenting and managing risk, emphasizing pro-active due diligence and contractual safeguards ensuring that IT teams can have a continuous complete view of their security posture. 

Conclusion: 

As biotech companies continue to rely on a complex network of digital tools, research partners, and service providers, the importance of robust third-party risk management is vital. Proactively identifying and assessing risks internally and externally enables organizations to protect critical assets like intellectual property, clinical data, and patient information. By integrating structured, repeatable risk management practices aligned with NIST guidance and industry regulations, biotech firms can not only improve their security posture but also strengthen audit readiness, streamline vendor decisions, and build trust with stakeholders. As the rate of attacks on supply chains increases, third-party risk management becomes absolutely critical in ensuring a healthy security posture.