How CROs facilitate the implementation of clinical trials: from planning to execution

Clinical trials are fundamental for the development of new treatments and medications. Conducting them not only has scientific and medical implications but also requires considering other factors (logistical, regulatory…) that must be managed effectively. This is where CROs come into play, specialized companies that provide management and support services for clinical research.

Clinical Trial Planning

Planning is one of the most critical stages for the success of the trial. CROs collaborate with sponsors to develop and review study protocols, ensuring they comply with regulations such as Regulation (EU) 536/2014 on clinical trials on medicinal products for human use.

Additionally, they are responsible for designing and preparing other documents such as data collection notebooks, selecting the best investigators and research centers, and negotiating contracts. When managing multi-country clinical trials, for example, CROs ensure that hospitals and investigators located in different countries work under the same quality standard.

Once regulatory approval is obtained, CROs play a key role in monitoring the trial, meaning they perform the necessary follow-up to ensure the research is being conducted according to the protocol approved by regulatory agencies. Clinical Research Associates (CRAs), also known as clinical trial monitors, make periodic visits to research centers to verify data quality and adherence to Good Clinical Practices (GCP).

When the Right Regulatory Strategy Makes the Difference

The success of a clinical trial not only depends on scientific results but also on regulatory compliance. Regulation (EU) 536/2014 establishes strict requirements to ensure the safety of participants and the reliability of data. CROs ensure compliance with these regulations, avoiding delays in the evaluation and approval of the study.

Taking the European Union as an example, considering how clinical trials are submitted through the European platform, the CTIS (Clinical Trial Information System), it is necessary to understand its functioning, evaluation times, “clock stop” periods, the number of days in which authorization can be expected, the maximum time frame for submitting substantial modifications or responses… Knowing which trial documents will be public and which will not is another critical factor for any clinical research sponsor.

CROs are, ultimately, indispensable partners in the implementation and execution of clinical trials. Thanks to their expertise in regulation, monitoring, and data management, they facilitate the development of new treatments and ensure regulatory compliance. In such a demanding environment as Europe, having the support of a CRO is key to the success of any clinical research.