No one will argue that we work in a risk-averse, regulated industry. This conservative perspective has enabled the belief that storing clinical trial data in the “cloud” can be quite scary. The problem is two-fold. First, quality processes have not evolved in tandem with technology. Second, it may be hard to look past early misconceptions about cloud technology and data security.
It is time to put those misconceptions to rest. The reality is that modern RTSM technology strengthens the quality process rather than weakens it. Before we delve into how, let’s spend some time understanding the limitations of physical data centers.
It used to be that all Software as a Service (SaaS) solutions, including RTSM systems, were hosted in owned data centers or co-locations (shared data centers). From a software quality perspective, a physical facility poses many challenges; How do you secure a data center in-house? How can you ensure the location you co-locate in has the level of security you need? Who can access the room? Is it fire resistant? What is the disaster recovery plan?
It also impacts change control; Who is making software/hardware changes? Who can access the servers? How are we documenting everyone who comes into contact with the systems there? Who changes out failed components? Full audit trails of these servers are nearly impossible with everything traditionally tracked manually through sign-in books and logs.
Given these limitations, there is an evolution from using physical data centers to hosting in the cloud.
Misconceptions of Cloud Technology and Data Security
When cloud technologies first surfaced, there were a lot of questions and skepticism. Where exactly is my data? Who will be able to access it? Is it secure? How do auditors and regulators feel about cloud technologies? Are regulatory authorities comfortable with clinical data being secured in a cloud?
Needless to say, cloud technologies and security have come a long way. Think about the banking industry. How many of you use online banking? Or use Amazon Prime? If other industries can take advantage of the power of modern technology, so can the pharmaceutical industry.
Paving the Way to Strengthened Quality Processes and Advanced Infrastructure Capabilities
Cloud providers, like Amazon Web Services (AWS), can actually enhance your quality processes and security. For example, AWS are experts in cloud-based computing and security, providing a level of expertise that you may not be able to provide with internal resources. The fail over capability and server maintenance is something most companies would need a much larger staff to accommodate. Having a cloud provider focus on the infrastructure enables technology and application providers to focus on the security and deployment of their applications, and further strengthen security by using security tools and monitoring on top of what is provided by the cloud provider.
In the case of AWS, you specify where in the world you would like your application and data deployed. With thousands of undisclosed locations for their hosting facilities, they can offer robust security for RTSM systems.
First, no one can get into the facility unless they are meant to be there, since the locations are unknown and secured.
Second, the disaster recovery (DR) plans are more comprehensive. With multiple locations you can implement cross-regional DR strategies. In the case of an emergency, you want to make sure there is enough distance between the impacted area and your back up server(s). Even if an entire AWS region fails, a cross-region plan would allow vendors to activate servers in unaffected areas, enabling your RTSM to function as intended with little-to-no disruption.
Third, sponsors can choose any of the locations to keep their data, so it can be in-country or anywhere in the world, without having to sacrifice security. This is particularly helpful to companies complying with strict data privacy regulations.
But, the benefits of AWS extend way past server locations. The capabilities of a modern cloud computing platform surpass anything a data center can offer. Full traceability can be built into the infrastructure.
AWS’s tools also allow for the continued practice of Infrastructure as Code (IaC), completely transforming the role of IQ (Installation Qualification) in software and ensuring environments where applications are built and tested are identical to production environments. It used to be that you had a box (server) and IQ personnel would install the OS, then the applications, and so on necessary for your software to run. When it came time to deploy it to production on yet another box (server), how did you know it was identical? The IQ was a checklist of actions: Did you download this? Check. Did you configure that? Check. Everything was tracked manually as you went along, but you could never be sure things were absolutely identical and done in the same manner and order.
With IaC, your server is built exactly the same way every time, making IQ merely a practice to ensure that your applications are running configured as intended. Instead of a traditional IQ tracking actions, it is now just a verification activity to check that your script ran correctly. This new IQ process is yet another activity that enhances the overall quality process by providing a level of QC not seen before.
Modern RTSM Technology Strengthens Quality
A modern, fully cloud-based RTSM can leverage all the benefits mentioned above to improve study integrity, protect data and ensure that everything continues to function as intended. Pair that with Agile methodology and a modern tech stack and you’ve got yourself a match made in heaven.
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