Making medical treatment, vaccines and other health advances available to people is the result of a long, careful and patient process of clinical research involving hundreds, sometimes thousands of highly trained people committed to the advancement of science and the well-being of humanity.
There are researchers and medical professionals on the one hand, and also voluntary patients who are willing to follow rigorous protocols to ensure good data collection, even if that involves certain restrictions or discomfort.
This complex process involves different stages, processes and responsibilities, and this is where Contract Research Organizations (CROs) play a key role.
CROs work closely with the pharmaceutical industry, academic institutions and other organizations, which act as sponsors, to carry out clinical studies. CROs are staffed by qualified professionals who participate in the planning, closely monitor the data, pay attention to patient safety and represent the sponsor before regulatory authorities, ethics committees and other stakeholders in the country in which the research is being conducted.
Their role should not be confused with that of “watchdog” of the process, but rather they are allies and co-workers in this long road, which is often very arid and complex. This is how we conceive it at BOPAL, with monitors who assist researchers at medical centers, focusing on the critical aspects of research and patient safety.
The services of a CRO may vary, but in general they include:
- Protocol development: detailed plan, in accordance with current ethical practices and protocols, defining objectives, patient population to be studied, data collection methods and success criteria.
- Selection of research centers: identify and manage the medical centers that will participate in the study, taking into account their geographic distribution, capacity to recruit patients and effective data collection.
- On-site and off-site data monitoring and management: regular visits to the medical centers to ensure that the study is being conducted as planned, in addition to collecting and thoroughly analyzing the data obtained by the investigators to ensure its reliability. The collection and checking is done on-site and off-site.
- Legal compliance: CRO are responsible for ensuring that the study is carried out under the local and international regulatory framework and, once concluded, they must order the results and submit them to the health authorities for evaluation. When approved, the drug or treatment can be marketed.
The role of a CRO is to deliver efficiency, quality and process optimization, which translates into shorter timeframes, controlled costs and reliable data that support and accelerate the approval of new medical treatments. Since 2019, at BOPAL we specialize in all phases of clinical research, providing continuous accompaniment and advice to investigators throughout the process.
We are proud to contribute to people’s health from our role as CRO in Latin America, motivated by challenges and with expert professionals who work tirelessly to obtain reliable and accurate results.