Why do you Need a CRO?
The management of a clinical study is more complicated than it would seem, since many actors intervene (manufacturers, sponsors, ethical committees, Competent Authorities, Centers, Foundations, Researchers, legal departments, participants). In addition, it is necessary to work under the rules of Good Clinical Practice and the Harmonization Guides (GCP-ICH Guidelines) that ensure the quality of the study. Being able to count on a CRO as a partner in which to trust the management of the study is essential and in this case the CRO acts as a bridge between the sponsor, the one who contracts the services, and the rest of the actors involved in the clinical trial.
How to choose a good CRO
Choosing a good CRO is very important, as much of the success of the study will depend on its management and will help the trial run as smoothly as possible.
Some of the questions to ask when choosing it are:
If you are looking for a CRO that can also advise you on the choice of centers, the number of monitoring and even the necessary sample size. In this second case, it is essential to find an experienced CRO.
If the way of working adapts to that of the sponsor
If the rates you propose are adequate and provide a clear and disaggregated budget
If it is a company committed to the study.
Services offered by a CRO
Traditionally, CROs have been in charge of initiating and monitoring clinical trials, but more and more we see companies offering all the services associated with conducting a clinical Study, such are considered “full service CROs”.
The services that a CRO can offer can be divided according to the phase in which we are in the study:
The start-up includes the development and revision of protocols for trials, the adaptation of the necessary documentation to the applicable legislation, obtaining the necessary approvals from the clinical research ethics committees and regulatory authorities, the design and preparation of the case report forms, the determination of the sample, the selection of the best researchers and research centers and the final negotiation of the contracts.
Once approval is obtained and the trial begins, the CRO offers its services for monitoring, which consists of controlling compliance with the protocol and with the procedures established for the development of the study. Likewise, pharmacovigilance services include detection and action in the event of the appearance of any Adverse Event.
The last steps to ensure the success of any clinical study are the management of the data, the generation of reports and the control and storage of the documentation.
Throughout the study, work is carried out in accordance with Good Clinical Practices (GCPs) that ensure the quality of the study.