Importance of CROs in Clinical Research31-03-2022
During a clinical trial (CT), researchers must collect and record infinity of data in a rigorous and traceable way. In other words, the results must be unequivocally identified, who recorded them, date, time, etc. Each center participating in a CT must keep strict control of its files, the same as the study promoters, that they must make a global follow-up of the progress of the investigation. For all this, they rely on the CROs (Clinical Research Organizations, also known as Contract Research Organizations), essential collaborators for the smooth running of a CT.
What is a CRO?
The CROs are the companies that support the pharmaceutical and biotechnology industries in drug research and that absorb part of the burden of the clinical stage of this process. Their role is fundamental, not only for the promoters but also for the researchers whose work they facilitate with training and constant contact to resolve doubts and unforeseen events that may arise during the development of the CT. Among the wide range of services that CROs can provide, they include the paperwork to carry out a CT, logistics, resource allocation management, database design, data entry and validation, maintenance and filing of databases or safety procedures, center, and patient recruitment, study follow-up and center monitoring, quality, safety, and efficacy reports, and biostatistics, among others.
Essential tools in the everyday conduct of a CT
Besides complying with the requirements of the specific legislation of each country, researchers must follow the particular procedures of each study. Although all CT procedures are detailed in the study protocol or in the investigator's brochure, they are not always easy to understand and perform. When a patient starts in a CT, all clinical and demographic data must be recorded, the informed consent must be saved, and data must be anonymized to preserve their identity. At that moment, the patient's file is created in which all the visits made, procedures, results, medication, side effects, and all the necessary information will be included so that the patient's data to be valid for later analysis. Years ago, all data was collected and stored in paper format, but today, most of it is collected and stored electronically.
CROs, in addition to the functions mentioned above, can provide tools that greatly facilitate the tasks of investigators:
- eTMF (Electronic Trial Master File): This is an application that leverages software and server technology to guide and assist in the setup, collection, storage, tracking, and archiving of essential CT documents.
- eCRF (Electronic Case Report Form): This constitutes an essential part of the development of clinical research. It is the application where all the clinical data obtained from the study are collected and managed in a case report form for later analysis.
- IWRS (Interactive Web Response System): A system that works like an IVRS (Interactive Voice Response Systems), but only with indications from a computer, instead of telephone indications, and supports automatic integration with other systems. It enables study administrators and investigators to securely interact with the study database using a standard web browser and email services. Both services can be accessed from anywhere in the world.
- CTMS (Clinical Trial Management System): It is the essential set of tools to effectively plan, manage, and monitor all ongoing clinical trials. It is a complete and specialized project management application that takes the study's research team from the beginning of the CT, through the registration and follow-up, until its closure.
- Remote monitoring: This allows the CRO to virtually monitor (review and transfer data and documents from a CT) a center participating in a CT, without the need for monitors to visit the center. With digital technology, CROs, sponsors, and CT stakeholders can view data anywhere with an internet connection.