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Spring 2010
Issue No. 2
Xclusive
Can you dispense drug through your EDC solution?
Bill Byrom
Senior Director of eClinical Product Strategy
Perceptive Informatics, Nottingham, UK
As Steve Kent, President of Perceptive Informatics, discussed in the last issue of the eClinical Xpert (Issue 1, Winter 2009), Perceptive's vision for innovative product design is to develop business process-driven solutions optimized for the way our customers manage trials. This concept directs our eClinical vision and represents a radical shift in the way technology is used in today's trials, having the potential to take efficiency in clinical trials to new levels.
One component of this vision is to create product convergence. Convergence is blurring the boundaries between distinct applications to make their combined use simpler and more efficient for the end user. In this article, we look at how Perceptive has applied this convergence principle to benefit studies where both EDC (Electronic Data Capture) and RTSM (Randomization and Trial Supply Management) solutions are used together.
From a site user perspective, the EDC solution represents the primary solution to perform patient-related tasks, in particular data collection and cleaning. In studies with more technologies in play, a user may also need to log into other solutions to perform related activities. While data integrations can eliminate a level of inefficiency and duplication between systems, there is still a physical need to maintain user accounts and credentials, log in and out of different applications, and maintain a level of training and competence in multiple solutions within a single clinical trial. Our research indicates that site users would benefit from a simpler approach.
Although EDC solutions have at times been used to administer randomization methodologies, in many clinical trials randomization is inextricably linked to medication allocation and supplies management which means that randomization functionality alone is of little benefit. Commonly, site users must log out of EDC and into RTSM either using the web (IWR) or phone (IVR) to perform randomization, dispensing or emergency pack replacements. They must then exit those applications to continue their workflow in EDC. Where data integration is in place, some of the values entered in RTSM may not require re-keying in EDC, but there remains a requirement to exit and enter different solutions to apply a simple sequence of tasks.
Perceptive recently announced the convergence between our DataLabs® EDC solution and our ClinPhone® RTSM solution, part of our eClinical Suite, which is specifically focused around these patient-level tasks. When a site is using the web, there is no doubt that it is easier for them to perform both the data management and the randomization and medication dispensing activities through a single solution – the EDC interface. As a result, Perceptive has made significant adjustments to our DataLabs EDC solution to enable this tighter product convergence to take place. Now within DataLabs EDC there is a specific RTSM action palate that presents the RTSM events that are available for a specific patient – including randomization, scheduled and unscheduled dispensing, emergency pack replacement and review of the subject’s dispensing log. These take the user to specific forms that are able to action live calls of the ClinPhone RTSM engine for the study, interchange data and present RTSM output in real time during the EDC session (figure 1). All this is performed without the requirement to log into a second system.
The solution is also built to display and report information concerning the connection between the solutions and report informatively on any errors or ineligible entries detected during the RTSM processes. This kind of convergence is not as simple as putting a web service in place between two applications. Adaptations to each product need to be made to enable this kind of integration to be implemented in an effective manner. Within the EDC solution, for example, is an integration management interface which enables the specific data points within specific visit forms required by the RTSM processes for each event type to be defined and mapped. In addition, the effective implementation of this kind of functionality requires a platform that supports these kinds of integrations, which has been an ongoing development focus for Perceptive.
Figure 1. DataLabs Randomization screen showing a live randomization event in progress between the DataLabs and ClinPhone solutions
This is one tangible example of the convergence principle that brings simpler working processes to our end users and illustrates one of the focal areas of our eClinical vision. Perceptive’s focus is ensuring our solutions work tightly together, leading to a more highly optimized environment for our site, sponsor and CRO users. |
