How to describe CRO activities in a grant application?
Accurately describing CRO responsibilities within a grant application is essential. It demonstrates that the project is operationally sound, compliant with GCP and relevant regulations (Regulation 536/2014, MDR/IVDR), and supported by qualified experts.
The application should make it clear that the CRO acts as a strategic operational partner — not merely a technical vendor. The description should include specific areas of responsibility, such as:
• Project Management – planning, coordination, oversight, reporting and stakeholder communication,
• Monitoring & Quality Control – ensuring compliance with protocol and GCP,
• Pharmacovigilance – safety oversight, SAE/SUSAR reporting, communication with regulators or safety oversight for medical devices (SAE/AE/DD/SADE),
• eCRF & Data Management – eCRF design, database management, data validation,
• Biostatistics – statistical analysis and final reporting,
• Regulatory & Documentation – submissions to ethics committees and competent authorities, eTMF management,
• Site contracting & financial administration.
Each of these areas should also be reflected in the budget — with specific tasks, deliverables and timelines. This increases transparency for evaluators and demonstrates that the project is well-structured and feasible.
Funding bodies such as ABM and NCBR expect clarity on how CRO involvement improves study quality, transparency and safety. BioStat provides sponsors with ready-made task descriptions and operational plans tailored to the application format. Our team assists in preparing both the narrative section and the detailed scope attachments.
Engaging a CRO during application development increases the project’s credibility and ensures alignment with regulatory and ethical standards.
