The Potential of LATAM.
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.
Historically, most clinical research has been concentrated in developed nations. This trend is obvious from the geographical distribution of clinical research publications; most of the publications and the research itself come from North America and western Europe.
Nevertheless, the presence of clinical research in Latin America growing steadily in the last decade, mainly because of cost effectiveness, excellent patient recruitment and the emergence of FDA approved regulatory agencies.