Case Study - Streamlining a Rare Disease Trial with Integrated Data Management

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Background

Our client, a fast-paced biotech company developing therapies for rare diseases, initially selected a clinical CRO for data management services while engaging Cytel for biostatistics and statistical programming services. After facing some challenges, the client decided to transition the data management services to Cytel to leverage our holistic approach to clinical development.

Challenge

Upon reviewing the previous vendor’s database, we identified several issues, including a lack of adherence to CDASH terminology in variable naming and a CRF design that was not optimized to reduce the number of programmed checks. This indicated that the database structure was not built to ensure fit for purpose data collection, facilitate data entry, and minimize cleaning effort. These design and build flaws increased the workload for data management (database set-up and cleaning), the sites (data entry and answering queries), and statistical programming (SDTM creation), driving up the overall budget and extending timelines.