From self-driving cars to cancer-killing nanobots, the past decade has taken huge leaps in technological advancement, moving us closer to a world our predecessors never imagined. In the same timeframe, clinical trials have become more diverse, and the economic landscape for pharmaceuticals necessitates quicker trial timelines. These pressures have prompted an increased need for electronic data capture (EDC) systems that help streamline workflows and increase collaboration, while lowering the cost of collecting, storing, and distributing clinical trial data.
We’ve compiled the following overview of the different forms an EDC system can take, as well as some guidance as to how to maximize the benefits of this technology.
What is EDC, exactly?
As most in the industry now know, electronic data capture modernizes data collection in clinical trials by leveraging the power and cost savings of technology to streamline the collection, storage, and distribution of clinical data. It’s the essential system in the larger family of eClinical technology, and the repository for almost all of the data that will be passed to regulatory bodies for scrutiny.
Why do I need EDC?
Even today, this is not such an uncommon question. If you run clinical trials, a well-thought out EDC system improves the efficiency of data collection – whether that data is first recorded on Fipaper and manually entered into the system, or captured directly through a computer. When compared to studies in which data is transcribed from paper into an Excel spreadsheet, EDC can offer several benefits including:
- regulatory compliance
- data quality
- data integrity
- patient safety
These benefits yield cost savings through reduced need for resources, faster study timelines, or a more nimble study structure that can adjust to changes more quickly.
While its benefits are many, however, an EDC is not the answer for every clinical trial. The process of collecting data on paper is tried and true, honed over decades to be as efficient as intrinsically possible. But just as spreadsheet software has revolutionized our ability to work with large datasets and speed analysis, EDC is improving the efficiency of collecting clinical data especially as the study size, study complexity, and number of sites scale.
In essence, EDC is simply another manifestation of the worldwide shift toward technology in all aspects of our lives, and the reduced complexity and increased convenience that result from it. For example, we no longer need travel agents to find the best flights and hotels when planning a vacation – this info is available online and booking is easy with a few clicks. While this may not be good news for aspiring travel agents, for the vast majority of travellers, the ability to access this data and make a purchase on their own terms has increased the convenience and lowered the cost of going on vacation. EDC simply brings these benefits – data aggregation, self-service, workflow flexibility – to clinical trials.
How do I choose an EDC?
EDC platforms come in a number of shapes, sizes, and flavors, and education on these varieties is key to selecting the right one for your project. One of the biggest questions to ask is whether a vendor is an on-premise solution or cloud-based system. Let’s briefly outline the differences between these two options:
- On-premise software - An on-premise system lives at the CRO or sponsor location, and is maintained by your IT team and supported by one or more programmers. The hardware can range in size and complexity from a single laptop to a rack of servers running custom-built software. It’s usually built from a standard base package, and customized with the addition of modular code and bespoke functionality.
- Cloud-based software – A cloud-based system, unlike on-premise solutions, lives on the internet. While it’s still dependent on a central server, that server can be located anywhere in the world, and the system is accessible from anywhere with internet access. Cloud-based software tends to come standard with more functionality, more frequent updates, and is typically more affordable, since the same software code base is being used by thousands of customers. Cloud computing frees up clinical-trial sponsors and CROs do what they do best – focus on gathering and analyzing data – rather than building and maintaining an on-premise IT infrastructure that requires data centers, real estate to house them, and skilled professionals to operate them.
So which of these solutions is best for you?
A lot of variables go into answering a question like this – there’s no one-size-fits-all solution. Study complexity, number of sites, and budget tend to be the major things that steer buyers to or from a specific solution. It may be more sensible to consider whether your study is better suited to the cloud, or to an on-premise solution. With that in mind, here are some areas of difference between the two systems:
- Time and cost – On-premise solutions tend to cost more over time, as they’re custom-built to a specific protocol and need a team to install and maintain. As a result, they tend to take longer to implement and set up – on average, 20-50% longer – and are harder to make changes to mid-study. But the benefits of having a system tailored to the study protocol can pay dividends on complex studies with unusual data requirements. Cloud-based EDC systems are more affordable because the functionality is off-the-shelf. They cater to the 95% of studies that have straightforward data requirements.
- Data accessibility – Cloud systems excel at collaborating in real time. A recent study found that 76% of CROs and 67% of sponsors are looking for tools to help with collaboration and data transparency, respectively. Cloud-based EDC gives sponsors and CROs visibility into the recruitment and data collection goals directly from their sites as well as a way to socialize real-time data between stakeholders.
- Monitoring – Another benefit of cloud-based EDCs is the efficiency of monitoring. If data is collected electronically through a tablet or computer, known as eSource, monitors are able to check source data through the cloud, instead of shipping paper or having the monitor travel to each site. Some of our customers have reported a 50% reduction in site visits, which results in significant cost savings.
As a cloud EDC provider, we like to think that cloud solutions are the future. In fact, many of the on-premise providers are moving to the cloud and its fast, convenient, and safe solution for the collection, storage, and distribution of clinical data at a lower total cost of ownership. For more information on how Medrio can help you focus on on your studies instead of the complexities of technology, contact us.