Having explored in detail the cyber risks all businesses face, I’m now focusing on a broader selection of risks facing a range of industries, including life sciences, healthcare financial institutions and manufacturing.
Clinical trials are integral to innovation in the life science industry. Human testing of the safety and effectiveness of drugs and medical devices has developed into a $30bn industry that is projected to grow to over $60bn by 2020.
The vast majority of research services are contracted out to CROs (contract research organisations) who provide specialist clinical trials services to the pharmaceutical, biotechnology and medical device industries.
With the pre-market approval stage within clinical development taking an average of ten years and costs running into the millions, CROs face enormous financial implications should the clinical trial be disrupted by any one of a growing number of potential risks and exposures facing the industry. I’ve identified 4 disruption risks facing CROs:
1. Stock contamination:
Drugs and biological specimens are extremely sensitive to variances in temperature and condition. Minor changes in storage conditions can lead to contamination of stock that could disrupt a specific trial phase, or force the restart of a trial.
2. Errors and omissions:
Due to the complex nature of the critical services CROs perform, there is a significant risk of accidental errors and omissions with regard to protocol design, transposition of assay test data or recruitment of participants.
3. Participant physical injury:
Human testing is a core element of the clinical trials process. However failure to adhere strictly to regulations and clinical standards can endanger participants and create the potential for litigation and financial loss.
4. Confidential data breach:
CROs are under constant pressure to feedback and report ongoing test data. They also store sensitive participant information and highly valuable intellectual property. A data breach, for example accidental disclosure of trial results, could lead to negative publicity, financial loss through business interruption, and possible patient harm if medical data integrity is compromised.
The life science industry faces many challenges in the development and delivery of new drugs, devices and treatments. CRO leaders need to address the complex risks facing their organisations in order to minimise the risk of business interruption leading to financial loss, and ensure the safety and privacy of all clinical trial participants.
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Scott Sayce, AVP – Head of Cyber, Technology and Life Science at CNA Hardy
I head up CNA Hardy’s Cyber, Technology and Life Science underwriting team and have specialised in cyber and technology for over a decade. Follow me on LinkedIn or Twitter to keep up with the latest insights from CNA Hardy.