Digital transformation in clinical research is reshaping how work delivery and financial integrity are monitored. A new concept paper proposes linking Trial Master File (TMF) completeness with project planning and revenue recognition to improve data quality, audit readiness, and financial transparency. By aligning TMF documentation with work breakdown structures and Gantt-based planning, the approach creates an integrated operational-financial model grounded in PMBOK, ICH GCP E6(R3), and accounting standards such as IFRS 15.
Read more: https://zenodo.org/records/16418598
Another recent preprint explores a conceptual AI-H budgeting framework to support structured financial planning in clinical trials. Leveraging ICH M11’s Schedule of Activities and generative AI, the framework supports cost estimation, scenario modeling, and feasibility validation using public protocols. It is designed to improve budget alignment with operational scope and regulatory expectations.
Read more: https://zenodo.org/records/15651378
