It's all About the Data and MetaData

DZS Implementation Philosophy for Clinical Trial Software

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Champions of Change

Any clinical development or clinical trial function needs to understand that it takes more than just technology to reap real benefits in the drug development process. In addition to the implementation of new software and systems, in order to maximize the benefits of either a paper-based or paperless clinical trial system, it is absolutely imperative that one must also institute and manage change across the entire enterprise. Usually this requires a project champion to effectively implement a range of operational changes.

For ultimate success, champions of change must:

1. Demonstrate strong leadership and an understanding of the various challenges of the implementation.
2. Be willing to set and work towards aggressive project milestones so the project doesn't loose momentum
3. Understand clearly the existing process and be willing to accept process redesign as an integral part of change
4. Use a proven, process change methodology. Successful redesign projects usually involve working with experienced line-level personnel that support a specific function. Senior managers should simply serve as sounding board to teams of line-level personnel
5. Any software/technology implementation invariably can alter the alignment and responsibilities of various roles in clinical development therefore, organizational change must be managed as actively as process change. And ideally, organizational changes should be rolled out simultaneously with any new system and/or new work processes.
6. Any new computer system must be tested before it is rolled out. This is a standard IT approach to system implementation. Yet, as mentioned previously, the benefits of new technology are achieved through work process changes. Despite this fact, few organizations jointly test the new processes and the new system. It is strongly recommended that an end-to-end process test utilizing the production version of the new system can help avoid problems and ensure that work processes are followed.
7. Unless personnel are adequately trained on both the new system and work processes, the benefits of the new system might be totally lost. Training should be designed around and provided to unique roles, especially if the responsibilities have changed. Such training is best provided by those line-level personnel who designed and/or tested the new processes and thus can discuss the logic behind new processes and the system.