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European Pharmaceutical Contractor

Calm in the Chaos

As much as technology is a good thing, too much can be quite tricky to manage, and the cycle tends to go gain-then-pain. By converging multiple applications, one can achieve a simpler, more efficient workflow

Historically, the pharmaceutical industry has always invested less in technology than most other industries. Although individual eClinical technologies used to facilitate clinical trials – such as electronic data capture (EDC) – have delivered dramatic improvements in trial productivity and data accuracy in recent years, the biopharmaceutical industry needs to move beyond the gains provided by these individual systems if they are to going to achieve the cost and time savings that are essential for their future success. Fortunately, that’s exactly what we began to see in 2012: the more widespread use of integrated and interoperable technologies throughout the clinical enterprise, combined with innovative clinical expertise and capabilities.

Anyone who has been associated with the application of information technology within clinical development will understand that there is a discernible cycle: implementation; followed by an incremental gain; and then the surfacing of new pain areas that result in the need for a further step change to address these. 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 EDC, clinical trial management systems (CTMS), and randomisation and trial supply management systems (RTSM) such as interactive voice response systems. Then came a period of incremental gain and pain; these technologies had saturated the industry and benefits were being realised, but users were having difficulty bringing them together.

A subsequent step-change in integration provided new improvements to the ways technologies were used collectively, and most eClinical technology solutions now have some capability to establish point-to-point connectivity between applications and to exchange data. While this has helped to reduce duplication of data and redundant activities, it 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 the combined use of many discrete systems and solutions has on a workflow. Until now, this has been the single biggest inhibitor 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 utilisation. The virtual elimination of the need for upfront 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 organisations 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 commoditisation 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 fueling 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 the workflow through product convergence and integration scalability, and allowing consolidated views of information for effective decision-making throughout the life cycle of a trial or programme.

Convergence and Beyond

Above all, clinical operations directors and data management directors of pharmaceutical companies are seeking convergence to make the workflow simpler when combining 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 when using products in combination

Sponsors and site users can benefit enormously, simplifying how they use multiple technology applications together in a single study or programme. 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 in 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 randomising, dispensing medication, replacing assigned medication packs, and reviewing the dispensation log) may now be performed through a single interface – the EDC application – thereby simplifying workflow. This eliminates logging in and out of multiple applications and reduces the training needs for sites. Feedback from sites about this functionality has been very positive to date, showing that product convergence in areas where it can simplify user workflow and training needs is a compelling proposition and one that sponsors and CROs might consider as a means to ensure happy sites.

Collaboration

Portal technology has already established a role in 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 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 accessible in the same place. Providing a simple interface to navigate these combined activities is becoming a major benefit for site users.

Tactical Versus Enterprise Application

The issue is about more than just interoperability. 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 new technology landscape differently, rather than simply “How can we use technology for this specific trial?” eClinical technology platforms – comprising of suites of products and the underlying cohesion through architecture and platform components – can provide an infrastructure that sponsors can use entirely to plan, design and operate their own clinical trials and programmes. There is growing interest among 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, for example, is beginning to look more like an enterprise-level solution. Clearly, 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 standalone business intelligence (BI) solution – another element in technology chaos – converged product suites can provide programme-level metrics and dashboards that aggregate and summarise 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. Furthermore, as with traditional BI applications, reporting can be tailored to address the different needs of different audiences.

How is the Software Industry Responding?

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 not looing for compatible solutions, but rather for solutions that provide them with integrated processes – a unified framework to optimise 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 will require massive investment and is likely to just be the beginning of a technological trend that will continue to emerge over the next decade.



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Bill Byrom is Senior Director of Product Strategy at Perceptive Informatics, a subsidiary of PAREXEL International Corporation, and has more than 20 years of pharmaceutical industry experience. Combining practical experience of roles within clinical development with a keen interest in leveraging technology, he is a key strategic thinker helping to shape the direction and future of eClinical technology solutions. He earned his BSc in Mathematics and Statistics at the University of Nottingham, and his PhD in Mathematical Modelling and Simulation at the University of Strathclyde.
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