What’s Missing in eSolutions: Enabling the Redefinition of Clinical Development

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There’s something missing from the eSolutions discussion. In fact, there are two key missing links: n eSolutions that are no more than bridges between silos will not meet the needs of a rapidly changing clinical development environment; and n Strategies, pilots, and initial use of eSolutions are skipping over the hard work of operational change management, as most industry-specific IT innovations do. Serving the Changing Environment Just as new information technology in the world at large brings a myriad of innovation possibilities to all industries, new market, business and science developments are generating the need to approach biopharma clinical development quite differently. If eSolutions strategies and tools do not enable the changing business structure, eSolutions will be expensive wasted investments. For instance, although CROs have been around for over 30 years, biopharma is again reinventing how it uses these services. The near future will feature complex relationships between sponsors and CROs, with high variability even within a single sponsor, and the traditional lines of responsibility and function will continue to blur, even as some sponsors begin to pull back from knee-jerk outsourcing. Because this is happening at the same time that government and the public demand more accountability and transparency, the need to gather, integrate and report knowledge (not just information or simple data) places sophisticated pressures on the clinical development function. eSolutions need to be part of, or indeed lead, the design of a new means of clinical development. If we do not re-imagine clinical development, we will fail to meet these challenges in a business environment of reduced financial resources. Does it make sense for us to continue to organize clinical development in silos that reflect the paper-based, pharma-centric, linear workflows of the past? Or do we need to have our work (and the technologies which enable it) reflect the patient-centric, multi-dimensional, nimble realities of today? How could we re-imagine clinical development? Instead of thinking in a linear workflow, should we focus our talent and technologies now by who our customers are (internal or external)? By customer need? By business objective (“project”)? By distinctive competency? These choices are hypercritical, because each leads to dramatic changes in human resources, inter-business dependencies, and therefore, eSolutions designs. If eSolutions to you means automatic reconciliation of the EDC and Safety System databases, that’s not re-defining clinical development — although it is a solution, to a real problem. Tying investigator performance to payment timelines without having seven sets of hands touching the process is a solution, to a real problem, but it’s not re-defining clinical development. So as useful as these solutions are, and challenging in their cross-silo integrations, in many ways these efforts simple are fighting the last war. Implementing for Success The gap between technology innovation and successful implementation is growing again. In many ways this is a repeat of the late 1990s, as the Internet brought great technical innovation but pharma had little understanding of or cultural tendency toward exploiting it. Just as the gap seemed to be closing sufficiently, technology and market forces have broken accepted wisdoms again. eSolutions undoubtedly will proceed, step by step, but we will stumble, losing years of progress, if implementation is not respected and understood. Have we learned from the early years of difficult EDC adoption? Have we learned from the extended, expensive CTMS projects? Have we learned from our underutilized adverse event systems? If we have learned, we know now that careful attention to organizational impact, sustained change governance, thoughtful process efficiency, and creative technology exploitation will be the keys to realizing the benefits of eSolutions we will require. n Ronald S. Waife, MPH, President Waife & Associates Inc. eSolutions need to be part of, or indeed lead, the design of a new means of clinical development. Waife & Associates, Inc., is a change management consultancy dedicated to the clinical research process. The company’s staff has served over 200 clients in the US and Europe since 1993. For more information, visit waife.com.

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