Is Unified Data a Better Solution for Clinical Trials?

Everyone agrees that clinical trials are costly, time-consuming, and increasingly complicated. But finding the solution? That’s when things get interesting.

A major IBM study uncovered a staggering statistic: Approximately 10 percent of clinical trial costs can be attributed solely to moving data around. That’s just one of the time consuming manual processes that drag down productivity in research. With technology driving efficiencies across industries, form music to manufacturing, why is clinical research not enjoying that same benefit?

Indeed, it’s ironic that in an industry so focused on breeding innovation, that companies are reluctant to make a change when it comes to clinical trial data management.Fountayn has asserted that many companies have become complacent with their clinical data management processes. They opt to stick with the status quo of how they collect data and what solutions they use to do so. Instead, we know the industry needs to start challenging itself.

“Challenge your staff to question their pain points and look further”

Encourage them to ask questions like…

Can our current technologies produce real-time, cross study reports?

Can we improve our efficiency, reduce risk and provide insight faster to improve patient safety?

Is our data accessible in real time anywhere, anytime, and if so, how does it help us?

If we have to make mid-study changes, can we do it easily without downtime, risk or hassle?

Does our eClinical solution solve our pain points or is it adding to them?

A New Way of Doing Business

With a unified data solution, complexities once presumed a requirement of eClinical solutions are removed. That means users don’t have to deal with the headache of data integration or tracing data back from disparate sources. But that’s just the beginning of the benefits.

With immediate access to all data on the platform, not only within a trial but across all trials, users can see and analyze data instantly. No more waiting for custom reports for hours, days, or even weeks. And you get the information you need to make informed decisions faster. That means improved patient safety, the ability to identify and correct issues before they become problems, and the creation of enterprise wide standards.   Repetitive, time consuming processes can be streamlined. With the ability to schedule future actions, at one time, standard imports, exports, and reports are automated. So the report that everyone needs, every Monday, is automatically delivered, based on the schedule set with that first request. No need to request that report again. As if that isn’t easy enough, the request process can be saved so it’s easily editable, without having to start from scratch. Not only does this save time and deliver actions as required by the specific needs of each trial, it gets the information needed to the people that need it easier.  

Consider the scenario where your site personnel have to enter data about multiple patients participating in different trials. Other systems require users to navigate to different home pages for each separate entry item.  A unified data solution enables those users to input that data using a single, intuitive user-interface.

That kind of simplicity is crucial to your data’s integrity. After all, staff members at clinical sites, doctors’ offices, and other data input locations are busy with a myriad of projects. Entering clinical trial data sometimes isn’t their top priority. Simplicity is the key to not only using the system but making it easy to learn. An intuitive user interface, responsive forms that present questions appropriate to each patient, and edit checks that fire upon data entry to quickly address potential mistakes improves data quality from the start.

Mid-study changes are also seamlessly and easily implemented when using unified data. Users can continue to work within the electronic Case Report Form (eCRF) during the change, improving the productivity of the trial. Enjoying instant data access gives users the opportunity to spot a potential problem at an earlier stage and fix it while it’s still relatively small. The benefits of early detection and correction are invaluable.

Companies should scrutinize existing workflows and how to best manage them. Today, many trials receive data from dozens of locations like a CRO or a doctor’s office. This leads to more room for error, damaged data and lost time. With Fountayn’s unified data source, disruptions are minimized or eliminated.

Don’t Overlook the Regulatory Benefits

Remember, the FDA estimates nearly one-third of all clinical trials are still done on paper. Market forces and regulators will continue to put pressure on any late-comers to use eClinical solutions to produce cleaner and more traceable data. That traceable component is where unified data also can help. Unifying data cuts down significantly on data migrations. And since the FDA says it spends more than 40 percent of its review time on tracking data flow back to the source, having a unified data solution could help speed up your clinical trial approval process, and ultimately the development of your drug.

The Additive Power of the Cloud

By now, we all have heard about cloud computing. The Cloud provides easy, on-demand network access across a shared pool of resources. It gives us ubiquitous access, scalability, and the ability to track and manage usage, usually at a cost much lower than an on-premises solution. And when used with eClinical solutions, the Cloud translates into significant time and cost savings.

 In your clinical trials, using the Cloud, is about a new philosophy – not just technology. Some solutions rely on products from vendors that don’t work together and tools that can limit performance. This results in slow trials with convoluted data entry. Using the Cloud, trials can see the benefits immediately and you have access to two-way communication without technology patches or other quick-fix bridges.

A Proven New Idea

It would seem to be common sense to recognize that controlled data housed in a single virtual location that reduces the risk of mistakes or data degradation would be superior to the old way of doing business in the world of clinical trials. But it’s not that simple. In fact, the biggest obstacle to embracing and benefitting from unified data solutions has little to do with technology. Instead, we think it’s about attitudes. People are averse to change. Unfortunately, some vendors base their product pitch on feeding that fear. The incentive for vendors to push for new standards and systems is low, but the reward is great. We think it’s time for eClinical solutions to focus on the benefits of a unified platform. Advances that can deliver greater patient safety, the ability to make informed decisions faster and the removal of complexities is available right now in technology. Let’s embrace the technology pushing the real benefits in the industry.

*Fountayn Formerly known as Datatrak