Should every grant project have CRO support?
Executing a research project funded by public funds not only involves achieving scientific goals but also meeting a range of regulatory, operational, and reporting requirements. As the number of clinical trials and Real World Evidence (RWE) projects funded by grants grows, the question arises: should every grant project be carried out with the support of a CRO (Contract Research Organization)? The answer is not straightforward, but practice shows that in many cases, working with a CRO significantly increases the safety and efficiency of project execution.
Formally, regulations do not require that grant projects be conducted with the involvement of a CRO. An academic sponsor, university, or medical institution can carry out the study on its own, provided it has the appropriate organizational resources and competencies. However, in practice, research projects—especially those involving clinical trials, medical device studies, or multi-center observational trials—require specialized knowledge in regulations, study management, data quality monitoring, and reporting in compliance with ICH GCP guidelines.
One of the biggest challenges for grant projects is balancing two parallel sets of requirements: those related to conducting clinical trials and the obligations arising from the public funding agreement. The sponsor must ensure the regulatory compliance of the trial, proper management of documentation, budget control, timely reporting, and readiness for audits and inspections from funding institutions. Lack of experience in any of these areas can lead to delays, increased team workload, and in extreme cases, the risk of challenging certain expenses.
CRO support goes beyond just operational execution of the study. It increasingly includes advisory services starting at the planning stage, feasibility assessments, timeline preparation, regulatory support, communication management with research sites, and oversight of data quality. This allows the scientific team to focus on the scientific and clinical aspects, while the CRO partner handles the efficient execution of operational processes and ensures compliance with formal requirements.
Not every grant project requires full outsourcing of CRO services. In the case of smaller, single-center studies, the support may be partial, covering areas such as biostatistics, monitoring, data management, or regulatory consulting. The key is to tailor the scope of cooperation to the scale and complexity of the project.
Experience shows that grant projects conducted without adequate operational support often face difficulties during start-up, reporting, or project control stages. Involving a CRO allows risks to be identified earlier, resources to be planned more effectively, and the project’s timeline and budget to be more predictable—critical in publicly funded projects, where flexibility for changes is limited.
Biostat supports academic and institutional sponsors in executing grant-funded projects with flexible collaboration models tailored to the specific needs of each study. This includes both comprehensive management of clinical trials and support for selected areas requiring specialized expertise.
In practice, the question is not whether a grant project must have a CRO, but rather at which stage CRO support will help reduce risk and increase the likelihood of project success. The appropriately selected scope of collaboration often determines whether the project will be completed efficiently, in compliance with funding requirements, and with full utilization of the granted funding.
