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European Biopharmaceutical Review

Data Privacy, Compliance, and Security


 

Data are perhaps the pharmaceutical industry’s most precious commodity. Each day, millions of data transactions occur, showing the result of treatments, documenting side effects, and telling the story of patients worldwide. However, as data practitioners, we must be mindful that the information we use to guide our decisions and drive our businesses does not belong to us.

Maintaining the highest possible data privacy standards is about more than just remaining compliant. It’s a badge of honour that says we treat the personally identifiable information (PII) of those who participate in clinical trials with the respect it deserves. With the right approach and expertise, data privacy becomes more than just a procedural chore, it becomes a tool that can help us transform the quality of the healthcare we and our partner stakeholders provide.

Compliance as an Opportunity to Thrive

When the EU’s General Data Protection Regulation (GDPR) came into effect in 2018, it created something of a frenzy across sectors. The rules present the clinicals trials industry, which is fully accustomed to operating in a highly regulated space, with a unique opportunity to further refine and more closely protect safety, boost patient engagement, and secure future drug development. GDPR applied arguably the world’s most stringent set of privacy laws to the largest global market for pharmaceuticals in Europe. However, it was not a uniquely new concept for the industry. In fact, compliance and/or misuse of data was already a well-regulated aspect for us in the internet age.

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Signant Health understands that global data security and privacy are critical success factors for customer success. As Chief Compliance and Security Officer, Paul Drake, PhD, is dedicated to meet and exceed quality expectations while protecting valuable data and assets. His responsibilities include quality management, information security, physical security, and regulatory compliance. Based in Hammersmith, UK, Paul and his team will continually identify opportunities to simplify compliance management, optimise customer audit performance, and accelerate innovation through continual and collaborative improvement. Prior to joining Signant, Paul led a distinguished career in security, quality management, and data privacy – including 20 years in senior roles primarily in the pharma industry. He also has extensive experience in complex integration work, building IT organisations, complex technology infrastructure, and change management. Paul holds a PhD in Critical Social Theory and Information Security, an MSc in Supervisory Management, and is a Master Black Belt in Lean Six Sigma.
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