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Presenting and accessing RTSM functions through an EDC interface: simplifying workflow and training for the site user. (Source: Perceptive Informatics)  

There is a discernible cycle associated with the application of information technology: implementation, followed by an incremental gain, and then the surfacing of pain areas that need step changes to address them. The pharmaceutical industry is beginning a step-change that promises substantial operational value at site level, while extending application from individual studies to a corporate, strategic level.

Earlier step-changes in the use of technology to support clinical trials took the form of implementation of isolated software applications such as electronic data capture (EDC), clinical trial management systems (CTMS), and randomization and trial supply management systems (RTSM) such as interactive voice response systems. Then came a period of incremental pain and gain. These technologies had saturated the industry and benefits were being realized, but users were having difficulty bringing them together.

A subsequent step-change in integration provided new improvements in the ways technologies are used collectively, and most eClinical technology solutions now have some capability to establish point-to-point connectivity between applications and to exchange data. This has helped to reduce duplication of data and redundant activities, but has not addressed the workflow of key users. The continued proliferation of applications and software suppliers has led to technology chaos. Technology chaos is the difficulty organisations have in integrating their growing set of solutions in a scalable manner, combined with the detrimental effect that combined use of many discrete systems and solutions has on workflow. Until now, this has been the biggest single inhibiter to progress.

Industry and technology trends
Two inter-related factors have contributed to the revolution—technical and cultural. On the technical front, software-as-a-service (SaaS) has transformed the potential for application utilization. The virtual elimination of the need for up-front investment in software and infrastructure, together with it no longer being necessary to carry large in-house support teams, has opened the doors to smaller pharmaceutical organizations to fully leverage technology solutions and their benefits. SaaS has also made it easier for larger companies to adopt alternative solutions.

SaaS-based licensing approaches, such as pay-per-use, and the commoditization of applications have each contributed to the cultural changes. In what has always been a very conservative sector, there is an increasing amount of outsourcing of clinical development; more strategic partnerships between sponsors and CROs; and, when outsourcing, sponsors becoming less dictatorial about which technology solutions should be used.

Both the marketplace itself and emerging technology are fuelling the requirements for optimal product suites that serve the full clinical trial process, but offer a way through the technology chaos. This is being achieved by simplifying workflow through product convergence and integration scalability, and allowing consolidated views of information for effective decision making throughout the lifecycle of a trial or program.

Convergence and beyond
Above all, clinical operations directors and data management directors of pharmaceutical companies are seeking convergence to make workflow simpler when using multiple technology applications in combination. Areas of development include:
• Identity management. Ensuring a common process and single sign-on across a product suite, leading to an uninterrupted workflow when moving between applications to conduct tasks. The benefits of a common user identity across a product suite have been described elsewhere.
• Product convergence. Enabling functionality that resides in one application to be exposed elsewhere to simplify user workflow.
Sponsors and site users can benefit enormously, simplifying how they use multiple technology applications together in a single study or program. We see sponsors beginning to seek federation between their own in-house system and vendor identity management infrastructures, allowing sponsors access to multiple-sourced applications without additional logon and user credentials management interrupting their workflow.

A notable example of product convergence is the way some vendors have invested heavily, simplifying the workflow for site users in the way they use the core trial applications of EDC and RTSM. This involves access and execution of some RTSM functionality from within the EDC application—either through web-service integration or by building the functionality into EDC. This requires additional objects and forms within EDC to enable intuitive execution in line with user workflow, taking the user-experience beyond the benefits of data integration. As an example, all patient-related RTSM tasks (such as randomizing, dispensing medication, replacing assigned medication packs, and reviewing the dispensation log) may now be performed through a single interface—the EDC application—simplifying workflow; eliminating the logging in and out of multiple applications; and reducing training needs (see figure).

Portal technology has already established a role deploying sponsor-facing functionality during study setup, such as the ability to publish and access online site feasibility and qualification questionnaires; and the exchange and sign-off of confidentiality agreements and contracts, protocols, and other essential and regulatory documents. It also has an important role to play sharing information during study conduct, creating forums, discussion, and news areas to inform the study community.

As vendors knit their applications together and present them in a single place, it becomes possible to add a layer of collaboration tools and other portal-type applications, all accessed at that same place. Providing a simple interface to navigate these combined activities is becoming a major benefit for site users.

Tactical vs. enterprise application
New technologies are prompting people to start to think in new ways—moving from a tactical, per-study use of technology to a wider remit that includes the management of enterprise policy. Some large pharmaceutical companies are looking at how to exploit this whole new technology landscape differently, rather than simply “How can we use technology for this specific trial?” eClinical technology platforms can provide an infrastructure that sponsors can use entirely to plan, design, and operate their own clinical trials and programs. There is growing interest amongst some sponsors to select a solution provider to play a critical role in delivering their own eClinical strategy without requiring internal systems, infrastructure, and support.

Consolidated operational data
Operational data reporting is beginning to look more like an enterprise-level solution. Reporting at a study level, with performance metrics, indicators, and dashboards drawn from operational data obtained from multiple applications to help monitor the progress of a study is still the prime objective. Nevertheless, the same techniques are beginning to be adopted more widely across the enterprise. Rather than a stand-alone business intelligence solution—another element in technology chaos—converged product suites can provide program-level metrics and dashboards that aggregate and summarize captured information in useful ways.

At a study level, the focus remains on performance of a specific trial, such as how quickly are the data being cleaned; how quickly are sites being set up; how is recruitment progressing? At the next layer, more high-level indicators are being employed, such as “Are the studies within my portfolio operating effectively; are we on budget?” Indicators and flags can highlight key performance indicators such as recruitment targets or data management targets. It is perfectly possible to take the concept one step further to create an index that measures the overall health of a trial, with the ability to drill down selectively through the layers of detail to specific issues. And, as with traditional business intelligence applications, reporting can be tailored to address the different needs of different audiences.

Software industry response
Industries such as the logistics sector were early adopters of the concept of interoperability, primarily through the use of open systems protocols. Cultural differences are dictating a different approach in the pharmaceutical sector. While many solutions are becoming adept in integrating data at the back end, the new challenge is how the use of multiple solutions can be accomplished in a way that makes user workflow straightforward and efficient. As a result, sponsors are looking, not for compatible solutions but for solutions that provide them with integrated processes—a unified framework to optimize the benefits of clinical trials technology.

In response, providers are working to make their collection of applications into a coherent and compelling product suite, while ensuring their framework standards enable the inclusion of other third-party systems within their environment. This approach requires massive investment and we can expect the marketplace to become dominated by a small number of large-suite providers.