How CROs Solve the eSource Conundrum

Contract Research Organizations and eSource

Contract research organizations have a fine line to walk. On one hand, they face the same mandate as anyone else involved with clinical research and drug development: delivering new treatments to market as rapidly as possible. This urgency has caused CROs to invest heavily in eClinical technology and other resources that unlock game-changing efficiencies, accelerating their arrival to database lock and regulatory submission.

On the other hand, CROs are, of course, service providers. Their sponsor clients compensate them for the time and services necessary to complete a clinical trial. As such, although the high costs and time-sensitivity of clinical trials naturally demand efficiency, CROs yield crucial revenue from providing the highest volume of services possible. This isn’t unique to CROs – “more business means more revenue” is, of course, a basic operating principle for any industry. But these competing incentives present a dilemma: How can organizations deliver the efficiency that clinical research demands in a way that doesn’t undermine their business model?

eSource: The plot thickens

One key to walking this fine line may lie in an area that has historically been sensitive for CROs: eSource. With established regulatory backing and proven effectiveness at reducing timelines, streamlining processes, and safeguarding data quality, eSource has revolutionized fundamental aspects of clinical research in the several years since it first started generating significant buzz around the industry. After working hard to get Medrio eSource onto the market, we’ve seen organizations of all types smoothly integrate the tablet app into their processes with great results.

But for CROs, the issue of eSource isn’t so cut and dry. For these organizations, the benefits of eSource come with concern over the impact to some of their core sources of revenue. Take monitoring, for example. CROs, especially the “Big 7,” have clinical monitoring as the bedrock of their business, and now fear that the eSource revolution puts this bedrock under threat. By facilitating real-time data sharing and syncing electronically-captured source data directly to an EDC, eSource eases the burden of monitoring visits and can nearly eliminate source data verification. We’ve seen organizations reduce their monitoring visits by half shortly after adopting eSource at their sites. For CROs, there’s just one problem with all this: monitoring is a major service provided to sponsor clients, and the notion of reducing it raises fears of an impact on revenue and staffing.

What these organizations are left with, then, is a tool that maximizes success on one side of the fine line – delivering timeline, cost, and resource efficiency to accelerate the market arrival of new products – while raising eyebrows on the other – keeping their service offerings robust.

What if CROs looked at it differently?

Realizing that organizations that resist the eSource revolution run the risk of going the way of the dodo, CROs and other organizations are reevaluating some of their conventional wisdom around clinical trial technology – including eSource. Sure, an invoice sent to a sponsor by an eSource-equipped CRO may not have as many monitoring-related line items. But this can be a good thing – even from a business perspective. After all, eSource, by streamlining processes and reducing study timelines, frees up time and resources that CROs can reallocate toward taking on a higher volume of clinical trials, thereby ramping up their output and growing their business. And organizations should have very little trouble filling their pipelines when they have a tool like eSource sending a strong message to sponsors: “we’re equipped with technology that will empower us to get your studies done faster than ever.”

Current market trends make the business case for eSource even more compelling. With sponsors increasingly outsourcing their operations to CROs, there’s more business to be had today than ever. To take full advantage of this opportunity, and to stand out among all the other organizations vying for it, CROs will need to do what they can to make themselves available and competitive.

eSource is still a relatively new frontier for much of the clinical research industry. Organizations of all types are designing implementation plans to maximize its benefits to their monitoring, data entry, and more. With eSource on its way to becoming standard in clinical research, it has been fascinating to observe CROs learning how to use the technology to reconcile the twin interests of efficient research and healthy revenue.