Role of the Medical Department in the CRO (Contract Research Organization)
CROs have emerge in the last two decades as essential organizations in clinical research. Although present in a few local CRO and fundamentally, in the central offices of large international CROs (Contract Research Organization), most of the CROs lack, in their local structure, medical departments dedicate fundamentally to essentially medical tasks and not to project management.
The presence of medical departments make up of specialists gives the CROs a key element in their structure, making them more competitive, as it provides a wide range of services and increases the quality of the trials, allowing them to be carry out more efficiently.
In the last two decades, CROs (Contract Research Organizations) have become essential organizations for pharmaceutical and biotechnology companies to carry out efficiently and with quality the clinical studies necessary for the introduction of new treatments in medicine.
Daily medical practice
Initially, the CRO (Contract Research Organization) were specialize companies, mainly in tasks such as data management and statistical analysis of these, which are activities in constant evolution, as a result of technological development and regulatory requirements.
The medical department provides the CRO (Contract Research Organization) with a key element for the execution of many activities intrinsic to clinical research, and in some way constitutes the nucleus on which numerous processes converge.
Thus, the medical department is already involve in the initial phases of clinical trials (Oncology Clinical Trials, Ophthalmology Clinical Trials, Gastroenterology Clinical Trials), contributing with its clinical knowledge to the design of the study and by extension to the preparation of the study protocol, and also being an essential interlocutor with the researchers.
The benefit derive from this medical support is substantial, increasing the scientific quality of the study and avoiding further amendments that will inevitably weigh down the clinical trial in question. The final consequence of all this is greater efficiency in achieving the milestones inherent in any clinical study.
During the life of the clinical trial
The role of the medical department acquires special relevance, performing functions as a medical monitor, establishing key interactions with the sponsor, investigators and trial monitors; clinically guiding the data collection and its purification, as well as the statistical analyzes to be carry out; preparing the final clinical report or providing medical support to the pharmacological management of the trial, manage by the sponsor or by the CRO (Contract Research Organization) itself.
Although the presence of a medical department is a notable add value in the structure of CROs, in the image and likeness of pharmaceutical laboratories, some CROs have not yet incorporate it into their structure. In this sense, it is striking, not only its absence in numerous local CROs, but also that CROs (Contract Research Organization) of great prestige and with a presence throughout the world, and that have large and qualify medical departments in their central offices, lack these departments in their offices.
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Spread across the globe
It is difficult to elucidate all the factors that contribute to this absence of doctors in some CROs, although some can be point out. For example, at the origin of the CROs (Contract Research Organization), more focus on other activities such as data management and analysis, but supervise by medical departments of the pharmaceutical industry itself.
The shortage of doctors, particularly specialists, in the pharmaceutical sector makes it extremely difficult to create competitive medical departments. The latter is not an impossible challenge, as evidence by the existence of highly qualify medical departments in large international CROs and in a few more local CROs (Contract Research Organization).
Undoubtedly, for the creation and consolidation of highly competitive medical departments, attractive research projects from a scientific point of view are necessary. In this sense, the potential of the medical department shall not be overlook as a factor for attracting international studies, generally larger than the local ones, carrying out medical monitoring tasks on a local or global basis.
The foreseeable consequences of this internationalization will be an increase in the knowledge of CRO (Contract Research Organizations) at all levels, having a positive impact on future studies, including purely local ones.
In conclusion
The presence of solid medical departments, in the structure of the CROs (Contract Research Organization), is key to the execution with quality and efficiency of the clinical trials (Oncology Clinical Trials, Ophthalmology Clinical Trials, Gastroenterology Clinical Trials) manage by CROs.
