CYBER SECURITY
as a patient risk, is growing. Given the intrinsic value of clinical trials
data, the reliance on decentralised trials management infrastructure, and the difficulty in holding cybercriminals responsible for their actions, sponsors, CROs and academic sites that participate in clinical trials must be prepared, knowledgeable, and vigilant.
Top six actions you should take to improve the security of your clinical trials 1. Employ a cyber-security professional (full-time or consultant) to help you develop a security strategy and ensure your organisation follows best practices to harden your defences against cyber threats.
2. Address system-wide security in your decentralised clinical trials strategy. This should include a risk assessment related to vulnerabilities to IP theft as well as PHI breaches.
3. Cyber security isn’t just your IT department’s problem. Incorporate responsibility/ accountability into your CRO and study site contracts, requiring disclosure, contingency planning, and cyber-incident responses.
4. Ensure training is adequate. Good awareness of social engineering, how to identify cyber attacks and mandatory cyber hygiene are key across the entire organisation. Consider background checks and screening of trials staff.
5. Be prepared for crisis management if required. A thoughtful plan to address issues if they arise will yield benefits if itmust be put into action.
6. Consider investing in cyber insurance to limit losses if – despite best efforts – you are the victim of a cyber attack.
Taking these six steps will help minimise the risk and potential impact of cyber attacks on your clinical trials.
References 1.
https://www.connerstrong.com/blog/insights-detail/hidden-cyber-
security-risks-in-clinical-trials/ 2.
https://www2.deloitte.com/content/dam/Deloitte/uk/Documents/ life-sciences-health-care/deloitte-uk-lshc-cyber-risk-ma.pdf 3.
https://cyberleadershipinstitute.com/how-cybercrime-may-derail- the-discovery-of-future-cures/ 4.
https://www.anapaya.net/blog/life-science-cyber-criminals-dont- want-your-money-they-want-your-ip 5.
https://wolfestone.co.uk/insights/blogs/pros-cons-outsourcing- clinical-trials 6.
https://www.medicaldesignandoutsourcing.com/how-covid-19- changed-medical-device-clinical-trials-forever/ 7.
https://www.mckinsey.com/industries/life-sciences/our-insights/ no-place-like-home-stepping-up-the-decentralization-of-clinical-trials 8.
https://mdgroup.com/blog/why-decentralisation-is-the-future-of- clinical-trials/ 9.
https://hbr.org/2021/05/ransomware-attacks-are-spiking-is-your- company-prepared 10.
https://www.nytimes.com/2020/10/03/technology/
clinical-trials-ransomware-attack-drugmakers.html 11.
https://www.techtimes.com/articles/253080/20201005/ ransomware-attack-slows-down-clinical-trials-for-covid-19-vaccine-
drugs-and-test-kits.htm
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