CRO (Contract Research Organization or Clinical Research Organization)
Although there are different types of CROs and diverse levels of specialization (distinct therapeutic areas for instance), typical CRO services include regulatory affairs, site selection and activation, recruitment support, clinical monitoring, data management, trial logistics, pharmacovigilance, biostatistics, medical writing, and project management, among others. Given that the clinical trials are going global, the large CROs usually have foot prints in all of these countries that are the usual spots for doing clinical trials.
In a clinical trial, CROs are hired by sponsors to perform a set of tasks, taking various technical and administrative responsibilities on the sponsor’s behalf.
The main role of the CRO is to plan, coordinate, execute, and supervise the processes involved in the development of a clinical trial, being a central contact point between the sponsor and other trial actors (e.g. ethics committees, regulatory agencies, vendors, and hospitals).
CROs are key players in clinical research, since they have the knowledge and the capabilities needed for the proper development of a clinical study. They help sponsors by reducing their workload, while ensuring trial quality and compliance with national and international standards.
At the same time, many CROs supply innovative technological tools to increase efficiency in the study processes, which translates into cost reductions.
Without doubt, CROs play a crucial role in the success of a clinical trial. Sponsors should carefully assess the particular needs of their projects, and look for the CRO that best meets their technical requirements and budget.
The website https://www.proclinical.com/blogs/2022-3/top-10-cros-to-watch-in-2022 listed the top ten CROs in 2022 which are:
- PPD (now part of ThermoFisher)
- KCR
- ICON (it just acquired PRA International)
- IQVIA (I still like their previous name Quintiles)
- Parexel
- Medpace
- Syneos Health
- Labcorp (it just acquired Covance)
- CTI
- PSI
An ARO is an academic or non-profit organization that provides support mainly to the academic principal investigators in the form of research services: biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance.
Comparing to the CRO, AROs are non-profit; are usually cheaper, are usually strictly related to their main center; are mainly focused on studies oriented to improve the standard clinical practice, thus they are majorly involved in observational studies, phase IV studies, pragmatic clinical trials,...
ARO can also be good to take on the role of the central reader and clinical event adjudications.
Comparing to the CRO, AROs are non-profit; are usually cheaper, are usually strictly related to their main center; are mainly focused on studies oriented to improve the standard clinical practice, thus they are majorly involved in observational studies, phase IV studies, pragmatic clinical trials,...
ARO can also be good to take on the role of the central reader and clinical event adjudications.
This book chapter discussed the role of ARO in clinical research:
Chapter 3. The Role of Academic Research Organizations in Clinical Research
The most prominent ARO is perhaps the Duke Clinical Research Institute (DCRI).
VRO (Virtual Research Organization)
With the recent rapid development in conducting the virtual clinical trials or decentralized clinical trials, the new term VRO is appearing. VRO is specialized in helping the sponsors to do virtual clinical trials. A paper by Hong et al "Virtual Research Organization: Nature and Forms" discussed the roles of the VROs.
An example of a VRO is ObvioHealth - they claim to be the VRO who are specialized in doing decentralized clinical trials.
