Does every CRO conduct studies funded by the Medical Research Agency (ABM)?
Not every CRO conducts studies funded by the Medical Research Agency (ABM). Although many research organizations on the market offer services in the area of clinical and observational studies, ABM-funded projects have a specific character. They require from a CRO not only standard operational competencies, but also experience in working with public funding and a thorough understanding of detailed formal and reporting requirements.
Studies financed by ABM are carried out in accordance with strictly defined rules resulting from call regulations, grant agreements, and provisions governing the use of public funds. This means that a CRO involved in such a project must be able to operate in an environment of heightened formal, audit, and reporting oversight. Not all research organizations have experience with this type of project or the appropriate internal structures to manage them effectively.
One of the key challenges is the need for precise cost settlement in line with eligibility rules. In ABM projects, particular emphasis is placed on documenting expenditures, distinguishing between eligible and ineligible costs, and ensuring that expenses comply with the approved project budget. A CRO without experience in grant-funded projects may find it difficult to adapt standard models used in commercial trials to the requirements of public funding.
Another important aspect is substantive and financial reporting. ABM-funded projects require regular periodic reports, cost statements, descriptions of project progress, and readiness for inspections and audits by the funding institution or other supervisory bodies. A CRO delivering such studies must have a team that understands the logic of public projects and can ensure consistency between study documentation, reports submitted to ABM, and source documents.
An additional challenge is the fact that, in ABM-funded studies, sponsors are often non-commercial entities such as universities, hospitals, or research institutes. Cooperation with such sponsors requires from a CRO flexibility, advisory skills, and support in areas beyond standard study management, for example in interpreting grant agreement provisions or planning schedules aligned with grant project milestones.
For these reasons, some CROs deliberately choose not to undertake ABM-funded studies or limit their involvement to selected scopes of services. Other organizations specialize in grant-funded projects and have dedicated procedures, teams, and experience that enable the efficient conduct of studies financed with public funds, while maintaining compliance with GCP and applicable legal regulations.
In summary, not every CRO conducts studies funded by ABM, as such projects require specific competencies, experience, and organizational infrastructure. When selecting a CRO for an ABM-funded study, it is important to consider not only clinical research experience, but also practical knowledge of public funding rules, reporting, and control processes. A well-chosen partner significantly increases the chances of smooth project execution and trouble-free grant settlement.
Would you like to learn about the experience of the Biostat team? Schedule a meeting with our consultant, and we will explain how our extensive experience in delivering ABM-funded projects can be applied to your study.
