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Winter 2010
Issue No. 1
Xclusive
Delivering eClinical by product convergence
Bill Byrom
Senior Director of eClinical Product Strategy
Perceptive Informatics, Nottingham, UK
What is eClinical?
The industry uses the term eClinical to convey a variety of meanings. Many use eClinical to simply mean an electronic technology – such as EDC (electronic data capture). At Perceptive Informatics, we differentiate eClinical from simply any technology solution, to mean technology solutions working together to create integrated business process-driven solutions. Specifically, these solutions are designed to provide optimal use for the way our customers manage clinical trials when using more than one technology application. This article explores this concept and how Perceptive’s eClinical solutions are uniquely focused on making life simple for those using multiple technology solutions in a clinical trial or development program.
To explore this, let’s first look at current practice in integration of clinical trial technology solutions.
The evolution of integration
Over recent years, the industry has seen enormous increases in the number of technology solutions available to help conduct today’s clinical trials, and the number of solutions in play within single studies. With this has come increased expectations of the way technologies will improve processes, workflow, study management and conduct. Bio/pharmaceutical companies and CROs face the problem that management and clinical data are contained within multiple internal and external systems requiring significant efforts to keep these in line with one another. Larger companies are investing within their IT groups to provide ways of integrating solutions, whereas others look to solution providers to ensure their applications can be used efficiently in combination with other products. Much of the focus of this activity has been from a technology perspective in terms of how data can be efficiently shared between applications.
One solution has been to build point-to-point connections between pairs of applications which can be used to exchange data using file transfers. This has proven successful, but as the number of applications has increased, so has the number of connections between systems making this solution more difficult to put in place, support and maintain (Figure 1a). A more sophisticated approach adopted by some, including Perceptive, is to employ a middleware solution to act as the receiver and controller of all messages between systems. In this way, each system only needs to be connected to a single application – the middleware – and the logging and auditing it performs provides complete visibility of the full integration process making integrations more easily supported (Figure 1b). Moreover, generic connectors for applications can be built so that new studies can utilize the existing integration framework without re-build.
Figure 1a
Figure 1b
Despite this, the focus of these integrations is still on passing data between solutions at the back end, and not on optimizing use of multiple applications for our front-end users.
Focus on optimizing the end-user experience
Even with integrated applications, users are required to log in and out of multiple applications as part of their natural workflow. This may involve going to multiple applications to view reports to understand the performance of a study. For example, a study director may routinely visit RTSM (Randomization and Trial Supply Management) reports to understand if adequate supplies are available to support the study, EDC to explore the data management process, CTMS (Clinical Trials Management System) for site and subject recruitment profiles and ePRO (electronic patient-reported outcomes) reports to understand whether subjects are complying with the requirement to complete an electronic symptom diary. Although some information may be common to each system, it is difficult to see all the information in one place to make effective management decisions. In addition, a site user may be required to log out of EDC and use the phone (IVR) or a different web application (IWR) to randomize a subject or dispense medication, and then return to EDC to enter additional related information.
The launch of Perceptive’s eClinical Suite is a significant step towards addressing some of these usability issues and providing a highly optimized user experience for customers using multiple technology applications. Still underpinned by our robust integration framework, we have focused on two areas to improve usability of multiple products within clinical trials. The first is reducing the requirement to visit multiple applications to obtain the full picture of clinical trial performance. The second is enabling users to access functionality that normally belongs in one application, directly from another without a requirement to log on to a second application – product convergence.
Consolidated data
Study managers have the need to access data from multiple systems to understand the progress and performance of their study or program. Fundamental to every trial is study management, data management and logistics. For this reason the standard interactive metrics we display through Perceptive Portal™ pull data from three pivotal applications: CTMS (IMPACT® or TrialWorks™), DataLabs® EDC and ClinPhone® RTSM. This provides interrogatable data on study ramp-up (countries and sites); subject recruitment; data management, SDV (source data verification) and queries; and adequacy of the quantity of supplies available (Figure 2). For studies involving other solutions other data may also be consolidated. For example, for ePRO or medical imaging, metrics describing diary compliance or image management may be included.
Figure 2
Product convergence:
Perceptive’s combined EDC-RTSM solution
Product convergence is the concept of making functionality that belongs to one application available through another. Consider Microsoft® Office. The module within Excel® that enables you to draw graphs and charts, can also be accessed through PowerPoint® and Word – so wherever you are you’re able to perform that function without having to open a new application. Our vision to provide the optimal user experience is to enable certain appropriate functionality to be accessed from other applications in this way. Our first eClinical release is our first step towards product convergence and includes the ability to randomize subjects, dispense and re-supply medication and provide emergency replacement packs for subjects through our DataLabs EDC interface. Aside from the integration framework supporting this, this has required significant development of our DataLabs solution to enable RTSM functionality to be easily accessed from the EDC solution. The benefits to users are that they can now perform all patient-focused activities including data collection, randomization and medication allocation, through a single product interface and a single logon. Behind the scene, all this functionality is still delivered by a separate RTSM application, so this does not prohibit sites using the phone to perform these activities if this is more convenient at the time. However, it simply means that when using the web they can perform all these activities in one place – optimizing their workflow and making the use of multiple technologies simpler (Figure 3).
Figure 3
What I’ve described in this short article is just some of the functionality we’re delivering within our first release of our eClinical Suite. Read more about all the features of Perceptive’s eClinical Suite here. We believe this is a major step towards delivering eClinical. Please contact us to arrange a demonstration of our eClinical Suite.
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