Remember when a clinical trial was run by one company using internal staff performing paper-based processes and relying on faxes, phone calls and home-grown computer systems? Those days are gone, thankfully. The business of running a clinical trial has changed steadily over the past 15 years. This continuous business process improvement, combined with technology innovation, has created new opportunities to increase efficiency in clinical trials, enable system and process integration, and increase accessibility of systems outside office walls.
We have all witnessed this from early days viewing static information on a website to the ubiquitous use today of wireless networks, mobile devices and apps, with virtually unlimited access to information; information that is increasingly available in the cloud. Clinical trials are not immune to its prevalence and most companies that haven’t already made the technological leap will do so soon. If you don’t have a strategy for introducing cloud technology into your clinical operations, you need one.
On the business side of clinical trials, companies have introduced various delivery models in an effort to decrease costs.
Some companies have outsourced whole business areas such as data management while others have consolidated and outsourced functions on a per-trial basis. Still another model is to outsource trial delivery to a single contract research organisation (CRO) or a set of preferred CROs.
While these changes have made for a more flexible and responsive operation, they have also resulted in an increase in the number of external partners and the amount of information stored and exchanged outside the company firewall. Extending information access to these partners has been inconvenient at best and historically has been solved with point-to-point solutions or even by creating internal user accounts for external partners.
On the technology side, pharmaceutical companies also began to reduce investments in computer hardware and infrastructure. Some companies moved data centres from internal company buildings to consolidated businesses run by experienced technology providers. The pharmaceutical companies IT organisations have also been reducing internal staff, off-shoring and outsourcing IT functions not just in clinical or R&D but across the entire enterprise.
There is a clear direction to buy and not build software applications. There has also been a concerted effort to create shared services for infrastructure and application support and maintenance. Enterprise architecture boards are pushing to standardise on enterprise-wide applications, and implement an enterprise wide IT strategy for procuring and managing hardware and software assets.
All of this change has produced requirements for IT systems supporting clinical trial operations that were not even considered just a few years ago and not even dreamed of back in the days of paper. Many companies now have locations around the world and have a need for all of their personnel to collaborate and standardise processes and systems. Systems and solutions now need to work efficiently in a distributed, global environment within a company and with external partners. Clinical trial information needs to be available, understandable and actionable on many devices.
The information needs to be easily shared and at the same time, stringently controlled. In addition, the need for sharing clinical has an expanded meaning – sharing not with just with a study team but also with partners, investigators, monitors, regulators and patients around the world. With over 25% of households around the world with Wi-Fi (over 50% in US and over 75% in some European countries), and the use of information search embedded in society, there is a subsequent rise in expectations of consumers, patients and governments in having quick and ready access to information. All of these new requirements make ‘the cloud’ something not to be ignored, but a reasonable strategic direction within the context of a larger R&D information strategy to meet the demands of the new operating models for clinical trials.
Cloud technology should be embraced as a good solution; it is the way of the future. In fact, why wouldn’t you use cloud technology? You don’t have to purchase, install and qualify hardware in your data centre. You don’t need internal IT staff to maintain the system. You can implement your new system in weeks or months instead of years. You can also update and expand your solution and give access to your solution to anyone around the world.
This sounds too good to be true and one should be cautious. What clinical trial professional wouldn’t be reluctant to depend on something as amorphous as a cloud? Clinical data is highly regulated and needs to be secure and access needs to be controlled and audited. In addition, there are laws regarding personal information and patient’s rights in many countries that will affect how you work with and store your information. How can you validate a system that is not in your complete control?
Risk and reward
Vendors in the pharmaceutical space know the potential of the cloud and also the reservations of a regulated environment and a cautious business customer. They are moving to cloud based solutions and offerings.
The chances are you may already be using a cloud-based application in your business today. In fact, many vendors have already been providing software-as-a-service (SaaS) solutions that are functionally aligned for areas like data management and clinical trial management. They are providing solutions that are data-type aligned such as for management of clinical documents. Strategic roadmaps for these vendors include expanding offerings into more and more of the clinical trial functions so that they can offer seamless integrated information in the life cycle of a clinical trial. The trend among vendors is to provide more extensive and integrated cloud-based solutions.
If you have an R&D or clinical roadmap, you need to include a strategy to incorporate solutions that utilise cloud technology to support clinical trial processes. You may also want to understand your Enterprise IT cloud strategy. Many IT organisations have policies and risk assessments for cloud-based solutions and may already have preferred cloud infrastructure providers.
Understand the security implications of using cloud technology. Engage IT security up front and understand the risks involved with cloud technology. Get to know about data center standards such as SOC2 that deal with controls like security, availability, processing integrity, confidentiality and privacy.
How will your cloud solution secure the data? Understand where your data will physically reside and if that is in line with data privacy laws from countries where you operate. Does the solution reside on a public cloud, a private cloud or a hybrid cloud? What are the risks and implications using a cloud-based solution on your clinical processes and validation? Your SaaS provider may also outsource its infrastructure to an infrastructure cloud vendor adding more complexity. All of these things should be incorporated into a company policy or strategy for securing and validating a cloud solution and then keeping it in a validated state.
A cloud-based solution does not change rules on archiving data. Where will the information stored in your cloud solution be archived? How would you decommission a cloud-based system? Where do you put the data after decommissioning? Because cloud solutions are new and exciting, and in the early stages of a life cycle, it is not really thought about what happens when they need to be shut down. What will be the total cost of ownership? You save money on investing in infrastructure and implementation costs can be much lower. But what is a reasonable licence and maintenance fee for such a service?
Finally, business intelligence and data analytics is another growing technology trend. Data analytics are becoming pervasive; many SaaS vendors have built-in data analytics and visual reports but you may end up with many different data analytic solutions and visualisation capabilities in silos in different cloud solutions. When looking at cloud technology, you may also want to consider how you can leverage data analytics with this solution and have a coherent strategy to provide end users a business intelligence and visualisation platform that spans many information sources whether in the cloud or within the company.
If you are thinking about using the cloud in your clinical trial operations, chances are you already have something based on it. While such solutions can get you going quickly, make sure you understand the risks and implications of control of your data and how it fits into the trial’s life cycle. Be sure to include IT in your decisions to ensure you have a robust, secure and high performing technology that will be a valuable asset instead of a burden.
