EClinCloud Analysis Identifies Reconstruction as Key Gap in FDA Inspection Readiness
A review of 1,715 FDA citations reveals that nearly half of all inspection findings involve protocol compliance and case history, rather than simple document storage volumes.
Ningbo-based EClinCloud has released an analysis of 1,715 FDA Bioresearch Monitoring (BIMO) citations spanning the 2020–2025 fiscal years. The data shows that 46.2% of occurrences relate to protocol compliance, informed consent, and investigator case histories. The findings suggest that regulatory inspection readiness should prioritize the ability to reconstruct trial decisions from the available evidence rather than focusing on the volume of documents stored.
The report challenges the industry's reliance on 'completeness percentages' as a primary metric, noting that high file counts do not necessarily establish regulatory acceptability. EClinCloud proposes a quality review framework based on five criteria: applicability, identity, timing, decision support, and retrieval capabilities. By addressing these factors throughout the trial, organizations can ensure that records reflect the reality of the study rather than an idealized filing system.
CEO Michael Qin argued that managing the Trial Master File (TMF) only at the point of closeout makes reconstruction impossible. The company’s integrated cloud platform aims to shift TMF management to daily trial execution, allowing for real-time visibility into document quality and traceability. This approach is intended to provide the evidence required by inspectors when verifying what occurred during a study and when.