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Navigating the Risks and Opportunities in Securing in Vivo Data

Modern technology has greatly improved our ability to collect, store, and share vast amounts of preclinical data, increasing our knowledge and ultimately allowing us to develop novel therapeutics more efficiently. But those advances can sometimes leave companies at greater risk of data breaches and, consequently, loss of intellectual property and consumer and stakeholder confidence.

This is where storing data in the cloud has its advantages. Reputable cloud service providers invest heavily in security measures and compliance certifications, often making cloud storage more secure than on-premises solutions.

The protection of sensitive and confidential information starts with a well-structured strategy that enables organizations to take advantage of all the benefits of cloud technology, including encryption, access control, periodic audits, compliance management, and continuous monitoring to detect and mitigate potential threats. By integrating security into every aspect of their cloud strategies, organizations can confidently harness the power of the cloud while ensuring the protection of sensitive information.

The Ins and Outs of Secure Data Storage

The purpose of storing any kind of data is to be able to access it later—except maybe your old high school yearbook, which can stay buried in the back of the closet. Such storage is great—until it gets accessed by the wrong party, whose nefarious intent may be ransomware.

Preclinical data is the penultimate output of sometimes lengthy and laborious experiments that lead to the go or no-go decision about a drug’s development. A single drug compound must undergo multiple experiments to gather enough data to make a meaningful conclusion on how to move forward. The time between the experiments can range from days to years. Data gets analyzed as research gets conducted. Or data gets aggregated and analyzed as a whole at a study’s end. In any case, data must be collected, stored, and managed in ways that make the data findable, accessible, interoperable, and reusable (FAIR).

Myriad commercial services exist to facilitate such processes, the vast majority of which rely on cloud technology. The cloud consists of servers placed all over the globe that users can access through the Internet by using software. Anyone, from anywhere, at any time can access the information as needed. For example, a company on the East Coast of the United States is collaborating with scientific experts in Australia. Data in the cloud enables the scientists to conduct collaborations with the US company in near real time despite the massive time difference between their locations. Unfortunately, this also means anyone else can access the data from anywhere at any time. I guess I also have to worry about those old college photos on social media seeing the light of day again. Well, gee, everyone had that hairstyle back then, I swear!

Modern Data Management Practices Fuel New Research Practices

Effective research data management (RDM) is critical to the modern research landscape. The ability to easily share data from, say, open-access consortia or between researchers enables scientists to offer feedback and collectively improve the trajectory of research with a view to gain insights at a rapid pace. Furthermore, and equally important, the publication of methods alongside the data allows others to reproduce a study, lending validity to the findings. Together, this enables scientists to confidently move forward with the research process.

However, the other hand is still there, ready and waiting. As data sharing has become easier and its positive effects on the research community have become clearly visible, threats to this new process are advancing every day. A recent Rackspace survey found in 2023 that 63% of C-suite board members cited cybersecurity as their number one business concern. According to IBM’s Cost of a Data Breach Report 2023, the global cost of a data breach was $4.45 million.

As cyberattacks increase in frequency and intensity, the pharmaceutical and biotechnology sectors must be proactive. The National Institute of Health has a data management and sharing policy; however, the unique security and compliance requirements for handling data should be firmly established with consensus from all functional departments and board members prior to selecting a vendor.

Five Strategies to Consider in the Safeguarding of in Vivo Research

1. Understand the risks inherent in facility security

Nowadays, validated entry methods such as electronically readable badges are par for the course and represent a clear first step in data security. Even if the cloud is ultimately where information is stored, mistakes happen. You might use, say, an unencrypted USB because you’re in a rush. Or you didn’t lock your laptop because you were stepping away for only a few minutes. Or you accidentally left that yearbook on the table after organizing the closet. OK, my hair really did look bad.

2. Review provider security measures

A security matrix outlines which security tasks the cloud provider handles and which ones the company handles. The cloud provider takes responsibility for day-to-day security requirements, has more-effective security capabilities, and can leverage those capabilities to reduce detection times and response times in handling potential threats. Plus, the use of a cloud system frees company resources for allocation elsewhere saving money overall.

3. Perform vendor assessments

Also known as a vendor risk assessment, the formalized process of vendor assessment enables an organization to establish whether vendors meet requirements for the management and security of the organization’s data. Key risk areas include strategy, financials, and compliance, and a company should continually monitor its vendors’ performances and stabilities in those areas for as long as the vendors’ services are in use. The company should also perform formal assessments of vendors annually. Check out this article for a guide on vendor assessments.

4. Learn the value of encryption

Data should be encrypted while both in motion and at rest. Encryption is typically a feature of any secure Web hosting partner, but encryption of hardware is important as well. For companies not yet fully digitalized, external hard drives present a significant risk because they are easy to lose and are often used outside the company, where Internet security features such as firewalls have not been implemented.

5. Develop a disaster recovery plan

Having disaster recovery and backup plans in place is also critical in the event that a data breach occurs. A cloud system can offer robust disaster recovery and backup solutions. In vivo data stored in the cloud can be replicated across multiple geographically dispersed data centers, reducing the risk of data loss due to hardware failures, natural disasters, or other unforeseen events. Automated backup mechanisms further enhance data resilience and availability.

Overall, leveraging the cloud to secure in vivo data offers a combination of robust security features, compliance management capabilities, scalability, and cost efficiency, which makes the cloud an attractive option for pharmaceutical companies looking to safeguard sensitive biomedical data. However, to mitigate risks effectively, companies must first carefully evaluate cloud providers and then implement appropriate security controls. After all, the transformation of labs to take advantage of technologies means keeping data safe—and speeding up the process of getting treatments to market.

Now, to move those online college photos and upload that yearbook to a secure cloud and destroy any physical evidence!

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