Clinical Trial Sites & CROs teams lose time and context when this work depends on inboxes, portal hopping, spreadsheets and individual memory.
The workflow is fragmented across systems and people, creating coordination load, inconsistent handoffs and late exceptions.
The intended improvement
More room for your expertise
Prevents clinical data disqualification during FDA audits, saving sponsors millions in trial delay and re-enrollment costs.
An intended benefit from the solution library. Validate it against your own process before implementation.
What this could look like
These illustrative stages describe a possible setup. They are not active capabilities or confirmed connections to your business.
Gather the request
Ingests daily Electronic Data Capture (EDC) inputs, lab specimen draws, and patient appointment logs across clinical trial sites.
Prepare the information
Evaluates visit intervals against strict FDA protocol time-windows, checks inclusion and exclusion lab thresholds, and flags early protocol deviations.
Human approval
Human review
CRA reviews flagged clinical discrepancies, confirms medical context with the Principal Investigator, and authorizes site queries.
Approved next action
Logs deviation reports for Institutional Review Board submission and updates Veeva/Medidata study records.