Clinical Research IO

Currently, the entire data collection process in clinical research is done on paper. Investigators at research sites record data on paper, then transcribe it into the pharma companies’ systems. Then the pharma companies send monitors onsite to review the source for quality control. This QC process consumes 25% of the total cost of a clinical trial ($6-$8 billion in aggregate spend), adds 2-3 months to the data closure process, and uncovers data issues that could have been caught at point-of-capture with an electronic system. To solve this, we plan to develop a software system aimed at clinical research sites. The system would let sites custom-build their own source templates, fill in data using a tablet, and thereby save time/cost and improve quality and productivity through built-in validations and improved workflows.