CROs in Medicine, a key support in the development of clinical trials
A Contract Research Organization (CRO) is in charge of the entire process of management, monitoring and development of a clinical trial.
A CRO in Medicine is a company that offers CRO services to support the management of clinical trials, their implementation and their monitoring. The functions offered by the CROs are increasingly broad, since the development of this type of experimental research studies is especially complex, due to the intervention of a significant number of factors, the interrelation of different actors and the existence of procedural requirements. legal and ethical standards that must be followed.
For example, for the development of a new drug, the clinical study that is carried out must go through different phases until its commercialization, where its safety and efficacy are already proven. The promoter of this new drug, in this case a pharmaceutical company, may choose to contract the CRO services to carry out all phases of the clinical trial in an appropriate manner, following the correct methodological, regulatory and ethical guidelines.
Functions and importance of a CRO
CROs are key to the success of clinical trials in the field of health. These companies are contracted by the promoters of the scientific study, generally from the pharmaceutical or biotechnology industry, or from the manufacturers of medical devices or health products.
Contract Research Organizations (CROs) provide support throughout the project. They have the knowledge, infrastructure and technical and technological means for the correct development of a clinical trial. They assume competencies that the sponsor should meet in order to carry out the clinical trial, to whom it offers a wide range of CRO services related to the project or scientific study that it wishes to carry out, with the aim of reducing its workload and, in some cases, , also the costs of the process.
For this reason, CROs in clinical trials usually act as a bridge between the promoter or entity that contracts the CRO services and the rest of the actors involved in the process, such as regulatory agencies, health authorities, foundations, hospitals, patient associations , among others. By hiring a sponsor to a CRO, you ensure that the CRO will comply with all the administrative, legal and ethical requirements that arise in the project, apart from guaranteeing the quality of the trial.
What services does a CRO offer?
The services that a CRO can offer depend on the phase of the clinical study, among which are:
- Start up
Project planning; contract negotiation; selection of research personnel for the study as well as the research centers that will carry it out; coordination of all the actors of the clinical trial (suppliers, hospitals, research centers, etc.).
- Adaptation of the project to the legislation of the country
As well as the protocols established in the matter.
- Obtaining the approval of the authorities
Regulatory and drug research ethics committees (CEIM).
- Sample Determination
What will be used during the procedure?
From the clinical trial.
Act in case an adverse event appears during it.
- Administrative processes
It is responsible for all that involves the clinical study and data management as well as the logistics of the trial.
Types of CRO in clinical trials
The success of a clinical trial often depends on the support it receives from the CRO. There are different CROs depending on their location, size or degree of specialization:
- CRO locales
Those that serve a specific geographic area; or, multinational CROs , with a large infrastructure and means at their disposal and with the ability to work anywhere in the world.
- CROs with expertise in certain medical specialties
As for example in the field of oncology or rehabilitation.
It is increasingly common to find that the promoters of clinical trials have the support of a CRO Contract Research Organization during the management and development process of a new health product or drug, since they fundamentally provide pharmaceutical companies with specific solutions and quality, both in the design of the project and in its development. In fact, it is also increasingly common for pharmaceutical corporations to outsource part of their drug validation processes with the help of these companies.
Master’s in Research in Health Sciences trains you to learn the main methodologies and tools necessary to participate as a collaborator in a clinical study from a CRO, within a pharmaceutical laboratory, or as a member of an investigation scientific research in a hospital or university center, as well as within health institutions or regulatory authorities.