EMD Serono, the biopharmaceutical division of Merck, wanted to improve its efficiency in the drug development pipeline, so it sought to streamline its clinical research process.
The leadership team was eager to move what were then paper-based data collection processes to an Electronic Data Capture (EDC) environment, to improve the flow of clinical trial operations and overall workplace efficiency. Complicating matters, as EMD Serono’s scientists had focused on their research, the processes they used for clinical trials and reporting had grown organically at different locations, becoming varied and needing standardization.
As experts in evaluating, redesigning and streamlining the way work is done, we documented the 30 existing processes EMD Serono used for its clinical research. Then, we analyzed these findings that showed “as is” processes and conducted business process reengineering to develop recommendations and define requirements for EMD Serono’s planned automation efforts.
Our multidisciplinary team:
- Analyzed the current clinical workflows, policies, information requirements, and reports of EMD Serono’s clinical trials.
- Produced a series of recommendations on an EDC system that would operate efficiently with existing back-end relational databases.
- Collaborated on the creation of a set of requirements and selection criteria, preparing detailed questionnaires for potential vendors, and evaluating responses.
- Helped select an EDC technology vendor that best matched EMD Serono’s requirements.
For EMD Serono, adopting these recommendations and using the tools provided yielded:
- Faster processes and efficiencies in EMD Serono’s clinical trial-to-regulator pipeline.
- Reduced administrative time for scientists. Scientists can focus on their research without being bogged down in the administrative aspects of finding and collating information.
- Lower costs. DIFZ’s analysis, highlighted ways to improve processes and positioned their automation efforts for success.