Which cost elements are most often overlooked by sponsors?
Even experienced sponsors may overlook certain costs — not due to lack of knowledge, but due to the dynamic nature of clinical research. Protocol amendments, regulatory updates and system changes can significantly alter project costs.
One commonly overlooked area is feasibility — assessing study viability before launch. Feasibility requires staff effort, communication with sites and preparation of a feasibility report. Although essential, it is frequently omitted from the initial budget.
Another overlooked area is document and operational plan updates. Protocol amendments, Investigator Brochure updates, revised informed consent forms, monitoring plans or project management plans all require review, alignment, system updates and communication with sites and regulators. Each amendment requires CRO work hours and additional system testing.
IT system updates (eCRF, IWRS, ePRO, eTMF) also generate ongoing costs — technical support, version updates, validations, archiving and backups. As a provider of its own eCRF.biz™ and eTMF systems, BioStat offers full transparency regarding implementation and update costs.
Sponsors also often forget about internal and external quality audits — required to ensure GCP compliance and prepare for potential inspections by national authorities or EMA.
A recommended practice is to include a financial buffer of 20–30% for unplanned activities — adding new sites, extending recruitment, updating documents or addressing regulator requests.
Based on BioStat’s experience, missing these elements is one of the most common reasons for budget overruns. We help sponsors adopt a predictive budgeting approach — creating flexible budgets that consider system maintenance, document updates and risk of protocol modifications.
BioStat supports sponsors in developing budgets that are both eligible (public funding rules) and resilient to operational changes — ensuring financial stability throughout the entire project.
