What experience should a CRO have to conduct a clinical trial? What criteria should CROs meet when participating in a tender?
Experience is the most important criterion when selecting a CRO. The smooth execution of a study, data quality and compliance with Good Clinical Practice (ICH GCP) depend on the knowledge and skills of the CRO team. A professional CRO should have a documented history of delivering clinical projects — both commercial and non-commercial — across various phases (I–IV), as well as observational and registry studies. Only an organization with this level of experience can foresee operational challenges and mitigate them effectively.
A key factor is the CRO’s internal team. Ideally, the CRO should have all necessary experts in-house — without relying heavily on subcontractors. Clinical trials require collaboration between specialists such as Project Managers, CRAs, biostatisticians, pharmacovigilance professionals, data managers and regulatory experts. Their familiarity with national and EU regulations, and their ability to coordinate study sites, are essential to project success. A reliable CRO employs a stable, highly skilled team with relevant certifications and experience gained during sponsor audits and regulatory inspections.
Technological capabilities are equally critical. In modern clinical trials, CROs should provide validated electronic systems — eCRF and eTMF — compliant with EU requirements and 21 CFR Part 11, ensuring data security and full audit trails. As part of the tender process, CROs should present evidence of past projects delivered using IT systems such as eCRF, IWRS and eTMF, along with documentation management tools and reporting frameworks.
If timely regulatory approvals are a priority, ask the CRO about its practical experience with the EU CTIS (Clinical Trials Information System). A track record of successfully completed submissions confirms that the organization understands the legal framework introduced by Regulation (EU) 536/2014.
When evaluating proposals, sponsors should also consider the CRO’s organizational flexibility, ability to operate in an international environment and readiness to adapt to sponsor-specific needs. A competent partner provides reliable timelines, transparent communication and proactive support in protocol design and site selection.
A professional CRO must also operate under a formal quality management system, demonstrated through certifications such as R&D Center status, ISO certification or equivalent standards, as well as a robust set of Standard Operating Procedures (SOPs) covering clinical trials, observational studies and medical experiments.
Finally, quality should be externally verified. CROs that have undergone at least one regulatory inspection or sponsor audit in recent years — without critical findings — demonstrate alignment with current regulations and industry expectations.
