In the highly competitive life sciences, biotechnology, and pharmaceutical fields, companies that put data security first have powerful advantages. Robust security is the heart of medical innovation, enabling the groundbreaking research required to develop new treatments, cures, and therapies. Up until recently, however, too few companies have made data security a top priority.
That’s starting to change. Sharing data — including proprietary research data, clinical trial results, and patient medical records — is a critical element of the medical research ecosystem and involves a collaborative process among stakeholders. Secure and ethical handling of this sensitive and regulated data across the entire research process not only preserves data confidentiality but also protects the well-being and privacy of individuals.
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This requires advanced data protection solutions that go beyond the outdated processes used today, including mountains of paperwork, couriers, legacy systems, and complex file-sharing systems. These traditional ways of sharing data can lead to delays and, more concerning, data security vulnerabilities. One recent article, How Can Providers Avoid Data Breaches? addresses the sensitive nature of healthcare data, the stringent regulations to protect it, and how the healthcare industry “must examine their use of legacy systems,” since many are no longer supported by vendors or are hard to update.
The highly sensitive nature of healthcare data — and the potential for security risks — is certainly not new. But what may be considered a new approach is the use of virtual data rooms (VDRs), which are secure and controlled, central cloud-based repositories that allow authorized users to store, manage, share, collaborate on, and transmit highly sensitive, confidential documents. VDRs have stringent security measures in place to protect against unauthorized data access and potential misuse including advanced security features such as encryption, multi-factor authentication, access controls, and audit trails that ensure sensitive information is protected at all times.
Developed as part of the due diligence process for the disclosure of confidential documents, VDRs provide a secure repository for all types of confidential materials including merger and acquisition (M&A) documents, financial statements, contracts, intellectual property details, and legal agreements.
Savvy life sciences, biotechnology, and pharmaceutical firms have taken notice. They are turning to VDRs to streamline collaboration among researchers, analysts, academic partners, patients, and regulatory authorities including the U.S. Food and Drug Administration (FDA) — all while meeting regulatory compliance throughout the entire research and development process.
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In clinical trials, for example, assessing the safety and effectiveness of medical treatments and ensuring the well-being of trial participants involve a vast amount of data: patient medical records, personal identifiable information (PII), genomic data, diagnostic information, laboratory test results, adverse events and side effects, drug formulation and dosage — the list goes on. A VDR makes it easy for a team of experts — everyone from the principal investigator to the clinical research coordinator, from the laboratory personnel to the ethics committee, etc. — to work with all this data securely.
That’s good news, because the future of clinical trials will involve even more data sharing, especially when more artificial intelligence and advanced data sets come into play. According to the National Institute of Health (NIH), “clinical trial designs are expected to become more complex in the future, generating even greater data volume and diversity.” Additionally, the report also forecasts that the introduction of algorithms will allow clinical teams to explore more options in real time, which “would foster more creative and complex study designs most likely to provide high-value scientific and regulatory data.”
In this high-stakes arena, the companies that win will be the ones rely on the technology and tools that promote collaboration while providing rock-solid security.
Photo: Traitov, Getty Images
Craig Clay is president of global capital markets for Donnelley Financial Solutions (NYSE: DFIN), a leading global risk and compliance solutions company.
Clay joined DFIN in 2016 to lead the company’s business strategy and support customer and market growth worldwide. Under his leadership, Clay was instrumental in transforming what was once a financial division of RR Donnelley into the leading regulatory and financial technology organization it is today.
Before joining DFIN in 1995, Clay was executive vice president of capital markets and global sourcing, RR Donnelley. He also served as leading financial analyst for American Eurocopter Corporation.
