What is a CRO – Contract Research Organization, at your service

The main function of the CRO is to work hand in hand with the sponsor, in order to plan, coordinate, carry out and closely supervise each and every one of the processes involved in the development of a clinical study, with which becomes a true business partner and main mediator between the sponsor and other study actors, such as ethics committees, regulatory agencies, providers, clinics and hospitals.

Its Contract Research Organization are not so well know by common people, but sometimes not by the scientific world either. The truth is that their activity has exist for a long time. CRO stands for Contract Research Organization. It is a firm that provides various clinical trial administration services.

CROs are companies that offer a range of clinical trial administration services to the healthcare industries, especially pharmaceutical, chemical, biotech, and medical device manufacturers, among others. When hire by a sponsor to conduct a clinical trial, CROs perform a number of tasks, including various technical and administrative responsibilities, all on behalf of the company they represent.

What is a CRO? - Contract Research Organization, at your service

Innovative technological tools

CROs usually provide innovative technological tools in order to increase the efficiency of the study processes, which translates into a great cost reduction. It is important to mention that there are different types of CROs and various levels of specialization, such as different therapeutic areas, different phases of clinical studies: the typical services of this type of organization include the following:

  • Feasibility
  • Selection and evaluation of research centers
  • Regulatory issues
  • Budget Negotiation
  • Preparation of contracts and collaboration agreements
  • Site Training
  • Quality Assurance Programs
  • Project management
  • Clinical study monitoring
  • Patient Recruitment and Retention
  • Regulatory issues
  • Pharmacovigilance
  • Import and export of medicines, supplies and biological samples.
  • Storage of medication, devices and supplies
  • Data Management
  • biostatistics
  • Closure of Sites
  • Preparation of Post-Study Report
  • Project management
  • QA

Complex work with a large number of actors involved

Of course, we cannot fail to underline that the work of the CROs is quite complex, both due to the sophistication of the studies and the number of actors involved in it, such as the following:

  • Manufacturers.
  • Sanitary and regulatory authorities (such as the Federal Commission for the Protection against Sanitary Risks, Cofepris ).
  • Legal departments.
  • Ethical, bioethical and scientific committees.
  • Researchers.
  • patients, among others.

In addition to this, there is a set of local and international standards and good practices under which these types of organizations are govern, such as the Good Clinical Practice Standards and Harmonization Guidelines (GCP-ICH Guidelines), in order to ensure the quality of the studies carry out.

 What is a CRO? – Contract Research Organization, at your service

A true business partner

In practice, the CROs become a true business partner of the sponsors and provide support for the management of the clinical study. In many cases, this type of center becomes a link between the person who contracts the services and the rest of the aforementioned actors with whom one has to work or knock on doors throughout the clinical study.

Sometimes the type of services offer by the CROS is not clear, therefore, however, the CROs take charge of the operation and monitoring of clinical studies, such as now the Phase 3 studies for the anti-Covid vaccines of the different pharmaceutical companies in specific populations, in this case.

Due to the above, there are more companies that offer all their services associate with conducting a clinical study, in order to provide a complete service, depending on the type of study that is request to be carry out.

The necessary adaptation

The start-up includes the development and review of protocols, the necessary adaptation of the documentation to Mexican legislation, obtaining the necessary approvals from the clinical research ethics committees and the regulatory authorities, the design and preparation of the data collection notebooks, the determination of the sample, the selection of the best researchers centers, in addition to the final negotiation of the contracts.

Once the approval is obtain and the study begins, the CRO provides its services for monitoring, which consists of the control of compliance with the protocol and the pre-establish procedures for the evolution of the study. Likewise, drug-surveillance services include detection and action in the event of the appearance of any adverse event.

The final steps to ensure the success of any clinical study are data management, report generation, and documentation control and storage. Throughout the study, Good Clinical Practices (GCP) must be follow to ensure the quality of the study.

Criteria for classifying CRO

The CROs can be divide according to the degree of specialization, in such a way that there are companies specialize in clinical studies, research with medical devices, or observational studies, in addition to centers specialize in a certain therapeutic area. Similarly, there are local CROs and others that are international, which are firms with subsidiaries spread over the five continents. Being large companies, they tend to be less flexible than local ones, but their coverage area is larger.

Local CROs are usually small companies, with fewer resources, but they offer the advantage of knowing very well the particularities of the countries, both at a regulatory and legal level, as well as the national idiosyncrasy. Given the above, it is very important to know how to choose a good CRO, which will be the one that best suits the specific needs of the client, as well as the times and budgets. The success of the study will depend on the good administration of the chosen CRO, because this will help the study process to develop as smoothly as possible.

Basic element in clinical studies

As can be seen, CROs are necessary actors in clinical research, since they have the necessary knowledge, infrastructure, and capabilities to adequately monitor a clinical study. They reduce the workload of sponsors, especially by ensuring study quality and compliance with national regulation and global standards.

CROs are a basic element in clinical trials, which also offer a wide portfolio of services associated with conducting the study, in order to facilitate the work of the sponsor. As we have see, there are many types of CROs, small and large, national and foreign, with less or more expertise . Therefore, it is essential to know what is expect of the CRO before signing contracts and starting to work together.

 What is a CRO? – Contract Research Organization, at your service

How to choose a good CRO?

When a good choice of CRO (Contract Research Organization) is made, the success of a clinical study is guaranteed. Sponsors must have all the elements at hand and know exactly the particular needs of their projects, in addition to finding the CRO that best suits their technical requirements and budget:

  • Review the CRO’s credentials to see their level of expertise .
  • Know if there is agreement between the client and the CRO.
  • Observe if the way of working is adapted to that of the sponsor.
  • If the budget is clear and adapts to the needs in a timely manner.
  • If you have the necessary and sufficient human capital to run the study.
  • Check the level of commitment.

By PiNaKIn

Leave a Reply

Your email address will not be published.