Insights

Blockchain in Clinical Research Sample Management

Distributed Ledger Technology (DLT) in clinical trials

Data collected from clinical trials helps advance the field of medicine, and both the usage and sharing of clinical trial data are important in drug development. In order to improve the efficiency and quality of clinical trial processes, it is important to leverage the data to drive site selection, patient recruitment, and quality execution.

Today’s clinical trial management operations involve a complex network of systems and data sources. Each data source may independently hold similar views of patient and investigator site information, including patient sample, storage location, and laboratory results. Yet clinical operations leaders in pharmaceutical companies often rely on manual data collection, such as compiled spreadsheets of data derived from multiple Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems, and laboratory systems, to assemble a complete picture of information related to the clinical trials. Manual compilation of data leads to process complexity and potential for data errors. Additional issues include data volume, data quality issues, assessment of data anomalies in real time, and out-of-date study metrics.

Blockchain technology for biological sample management may provide a solution to addressing these challenges in clinical trials. Blockchain, a Distributed Ledger Technology (DLT), can provide a fully transparent and shared data infrastructure that is continuously updated by stakeholders and provides sample information in real time.

Authors:
Chuck Drucker, Head of Alliance Management, Q2 Solutions
Mike Hamill, Chief Information Officer, Q2 Solutions
Guy Rachmuth, Head of Strategy, Q2 Solutions
Jian Wang, President, BioFortis, a Q2 Solutions company

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