Streamlining Clinical Trial Processes

Client Situation

Serono Pharmaceuticals (now Merck Serono S.A., the biopharmaceutical division of Merck), wanted to improve its efficiency in the drug development pipeline, so it sought to streamline its clinical research process.

Serono’s leadership also 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. 

The Digital Infuzion Solution

While Serono’s scientists focused on their research, the processes they used for clinical trials and reporting had grown organically at different locations. As experts in evaluating, redesigning and streamlining the way work is done, Digital Infuzion documented the 30 existing processes Serono used for its clinical research. Then, Digital Infuzion analyzed these findings of “as is” and conducted business process reengineering to determine the optimum way to proceed.

Digital Infuzion:

  • Analyzed the current clinical workflows, policies, information requirements, and reports of Serono’s clinical trials.
  • Produced a series of recommendations on an EDC system that would combine efficiently with existing back-end relational databases.
  • Helped select an EDC technology vendor that best matched Serono’s requirements.
  • Collaborated on the creation of a set of requirements and selection criteria, issue-detailed questionnaires to vendors, and evaluating responses.


  • Faster Processes: As process technologists, Digital Infuzion brought efficiencies to Serono’s clinical trial-to-regulator pipeline.
  • Freeing Scientists’ Time: Scientists benefited because they could focus on their research without being bogged down in the administrative aspects of finding and collating information.
  • Saving Money: By reviewing Digital Infuzion’s analysis, Serono’s team clearly understood where improvements could be made in their processes, so their automation efforts would be successful.
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