Daily interactions with Sponsors took the BioClinica team around the globe, from Boston to Utah and Belgium to Israel in 2013, where we observed some interesting trends. Last year — more so than any other in recent history — marked significant change in what customers want from their eClinical systems.
We're seeing an overall shift where Sponsors and CROs alike want their eClinical technology to do more, perform better, and shave costs from additional areas of clinical research compared to just a few years ago. Take for instance CTMS. Whereas the typical customer once used CTMS primarily for milestone and payment tracking, now the best-in-class systems are capable of doing that plus off-line trip reports and integrated invoicing. Let's take a deeper look at what else we're seeing.
Hottest eClinical Trends
Study designs are becoming increasingly complex and so too is system functionality as Sponsors and CROs become more experienced with eClinical systems.
With most Sponsors replacing manual paper methods with EDC in the past five years, the benefits of increased quality have been experienced first-hand. Now they're looking to get even more from their technology platform, including reduced source data verification and a more automated workflow.
Increased interest in sites having the ability to enter data directly into the EDC system, entirely by-passing the paper-based source process.
While some organizations find it difficult to move away from a "We've always done it this way" mentality, continuing paper source practices, others have been doing eSource for years. Early adopters capitalized on direct data entry as the most efficient means of getting data into an EDC system, outpacing those who've yet to make the switch. This will be made even easier with apps designed for mobile devices such as BioClinica's Express EDC apps.
Dramatic increase in the use of alerts in all eClinical products to track Serious Adverse Events (SAEs), subject enrollment, discontinuations and similar activities.
Sponsors are using electronic communications with greater frequency and are exploring extended uses in other areas. Email and text messages are among the most widely used forms of communication ─ and not just for Serious Adverse Events ─ but also for more complex signaling.
Smoother and faster study build and CRF design process thanks to broad adoption of CDISC standards.
The use of CDISC standards makes clinical trial databases more consistent and predictable to create. The standards provide a common language for building forms and submitting datasets and the predictable models shorten development times.
An explosion in the adoption of CTMS by companies of all sizes to manage vendors and track study operational information.
Whereas in the past, Sponsors tended to use one CRO to manage most study aspects, they're increasingly selecting 'best in class' providers for individual functions. Today, it's fairly common to have one CRO for monitoring, another for data management, and yet a third for statistics. And with Sponsors seeking greater control of study data and metrics, they're demanding greater insight to operational aspects, especially from their CROs.
These trends point to continual advances in cloud-based technology, which make all of this change possible. For example, BioClinica had several sponsors switch to OnPoint CTMS to get better insight into their operational data -- in real-time -- to help them better manage their CROs.
Falling right in line with these new trends is a more rigorous technology evaluation and vendor selection process to identify eClinical systems and technology providers best-suited to an organization and its clinical research programs. We are being asked to demonstrate detailed custom scenarios and use cases more than ever before.
As for what's next, I expect that we'll see these trends continue to play out across 2014, with increased interest especially in systems integrations and quality metrics. So is your organization on trend with what we've observed with our customers?
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