Fujirebio Increases Study Agility By Streamlining Clinical Operations And Data Management Process

The Challenges

Fujirebio launched its first IVD test kit over 50 years ago and since then the company has seen steady growth over the years, including acquisitions of best-in-class IVD companies such as Centocor Diagnostics, which became Fujirebio Diagnostics, Inc. in 1998. As demand in this market segment began to rise, the company took its success to new levels. Led by Rachel Radwan, Director of Clinical R&D, the U.S. clinical operations and data management team doubled in size to accommodate an increasing volume of work.

Traditional data entry and review processes using spreadsheet trackers and paper were no longer sufficient to ensure fast and high-quality submissions to the FDA, Rachel said. Simultaneously, concerns grew about the increased risk of human error, quality issues, and delays as faster, shorter studies with higher complexity were planned. As a result of this, there was a need for faster, more accurate data, and a more streamlined data management process.