The Next BIG Thing in EDC The most compelling evidence for the argument that electronic data capture (EDC) is entering the mass adoption phase of its technology life cycle is the rate at which sponsors and CROs are internalizing the development processes. Technology transfer or in-licensing of software for use across an enterprise is a sure sign that EDC is enjoying a huge surge in adoption. But undertaking technology transfer brings a different set of considerations than using the software on a per-trial, outsourced basis. EDC vendors need to have four essential ingredients in place to make technology transfer successful: a proven, repeatable transfer process; tools to ease development and testing; a top-notch training program for internal and external use; and employees who understand the clinical process and are proficient at adapting technology to that process. Technology Transfer Technology transfer should be an iterative process that occurs over a series of clinical trials, not a one-time event. Too many vendors either hand over software disks or require millions of dollars in consulting fees to get sponsors up and running. These methods are neither cost-effective nor do they adequately prepare clinical teams and data-management departments for integrating technology with process change. More emphasis should be given to how well an EDC vendor is able to replicate a consistent transfer process that enables each client to easily and rapidly get the most out of the technology. As in franchising, vendors should provide centralized resources, a common process, and corporate oversight to guarantee success. Back-End Tools Just as important as ease of use is for the front-end data entry component, it is an even more critical differentiator for the back-end design and deployment tools. Because many EDC tools were designed for internal programmers to use, they lack the necessary intuitive interface that makes it easy for data managers and clinicians to use. Sponsors and CROs need tools that not only provide drag-and-drop functionality for designing eCRF pages, but also effortlessly construct the database tables and structures simultaneously. Validation and Testing There is also the issue of validation and testing. For technology transfer to truly be successful, vendors must supply back-end tools to test that their systems can scale to meet the needs of the study as well as automate the QC process. By taking this forward-thinking approach, vendors prove that they have spent time carefully considering the impact of software in-licensing and demonstrating to sponsors and CROs that the impact of their technology adoption will be minimal and positive. It is not enough to throw software at a sponsor without guiding them through the implementation. Technology transfer needs to be well planned and designed in such a way that the process checks itself. Knowledge transfer is another critical component to a successful technology transfer. Whether the training program is developed by leveraging internal subject matter experts or in partnership with world-class training companies, the EDC vendor has a responsibility to equip clients with the tools, knowledge, and resources necessary to effectively use the technology to build their own studies and be able to adapt it to their own systems. It must be comprehensive, scalable, and able to accommodate investigator sites as well. This will expedite hand-off and ownership of the process, as well as ensure overall, ongoing program success. The Team Last, but certainly not least, is the team that is responsible for the technology transfer. Human capital is a company’s most important and valuable asset. It is the EDC vendor’s staff of experts who understand the clinical process, talks with clients about how technology fits into their process, and supports process changes. They will be a point of differentiation, and it is their experience and expertise that will ensure a smooth transition and implementation. Not only has the bar been raised on what it takes to implement an EDC technology transfer, but also the model has changed. Because it is an iterative process, it requires a different set of considerations for successful deployment. Before selecting an EDC vendor, sponsors and CROs should evaluate the completeness of their offering in four distinct areas: how repeatable is the technology transfer process, how robust and user-friendly are the back-end tools, what training systems and processes are in place, and what are the credentials of the team that will implement the e-clinical solution. Upon satisfactorily addressing these issues, pharmaceutical organizations will be assured of success in implementing the next big thing in EDC — their own thing. John Cline CEO Not only has the bar been raised on what it takes to implement an EDC technology transfer, but also the model has changed. Because it is an iterative process, it requires a different set of considerations for successful deployment. the e-arena etrials Worldwide Inc., Research Triangle Park, N.C., offers an efficient e-clinical platform for collecting, reviewing, and distributing both quantitative subject information and educational resources for physicians and patients. For more information, visit etrials.com. May 2005 VIEW on Biotechnology
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The Next BIG Thing in EDC
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Biotech