The CRO plays an important role in the management of clinical trials and research. In this guide, you will learn what a contract research organisation does and why they are a must, and where clinical translation comes into play.
Contract research organisations, or CROs, are crucial to the success and quality assurance of clinical trials and studies. Whatever the purpose and nature of the study is, they play an important function, some of which you will discover here.
Introduction to Contract Research Organisation (CRO)
A contract research organisation is an independent company that aids the pharmaceutical or medical companies that are conducting studies or research in their respective fields. The nature of the research could involve the development of a new product, post-marketing research, or something else. Aside from private companies, CROs can also aid in the study and research for foundations and universities.
As the name implies, they are hired to aid in the research on a contract-basis only. This means that they are not part of the organisation that is conducting or sponsoring the research. They act as a separate entity with various areas of specialisation. A few examples of specialised CROs are in the field of biotechnology, pharmaceutical, and medical devices, to name a few.
The Role of the CRO
Contract research organisations play an important role in the conduct of clinical studies. They offer a wide range of services that include, but are not limited to, the following:
- Site selection and organisation
- Site management
- Monitoring of clinical study protocols
- Data management
- Logistics
- Medical writing
- Project management
- Regulatory affairs and compliance
To put it simply, CROs offer the industry a type of quality service that ensures that organisations are updated in terms of compliance standards and technology. They also facilitate the development of new strategies to improve the results of the research study for the completion of its objectives. This is why, it is also essential that any translations required are produced by someone why is an expert in the medical translation field.
Factors When Choosing a CRO to Hire
The goal for any clinical research organisation or sponsor is to hire a competent CRO. The right selection gives you confidence that you have a reliable partner in meeting the scientific and regulatory requirements of the research study.
To make that happen, it is important to consider the following factors in the CRO selection. While most CROs appear to offer a similar set of services, they are not made equal.
- Timeline and budget – Cost reduction is one of the primary motivators for organisations to outsource with a CRO provider. When enlisting the services of a CRO, make sure that they can meet your timeline and budget targets. Otherwise, you could end up spending more for the clinical research study.
- Related experience – Has the CRO assisted in a similar study in the past? Knowledge is essential but experience is a crucial part of success in clinical research and study. Their previous experience can teach them a thing or two that could benefit your current study.
- Knowledge of local regulatory environment – Hire a CRO that is abreast of the regulatory requirements within your geographic area or region. It increases the chance of your clinical study being approved.
- Client satisfaction – Do your research. Look at the feedback from former clients about the services provided by the CROs you are considering for the project.
- Infrastructure – Make sure that the CRO has a solid infrastructure that you can leverage for the study. This is where the significant part of your cost savings will come from.
Why Are CROs Important in Clinical Trials?
The functions of the CROs are known; so, how important are they? Is it possible to proceed with the clinical study without hiring one?
CROs take on the specialised tasks that are beyond the scope of knowledge for the clinical trial facilitators and sponsors. They bring in a wealth of know-how and access to resources that are unique to the specifications of a particular study.
Without the CROs, the clinical trial sponsor would have to acquire the resources, which would significantly increase the cost of the study. At the same time, the access to the specialised skill and knowledge might not be possible with the in-house research team. For this reason, subcontracting is the next best option.
By gaining access to the technical proficiency and knowledge of CROs, the quality of the results you get from the clinical trial also significantly improves.
Advantages of Hiring a CRO
The primary advantage of hiring a CRO is the ability for the sponsors to focus on the core aspects of their business, and for the main research team to focus on their main roles and responsibilities. There are plenty of tasks involved in a clinical research study and each of these tasks require a certain set of skills or knowledge. It is crucial that the right people are designated to handle these tasks to ensure quality results and to preserve the integrity of the study.
For example, subcontracting with CROs give clinical trial sponsors access to knowledge, resources, and contacts that are not readily available to them. They also bank on their expertise and experience in the conduct of clinical studies to improve patient enrollment in the study. This last component is vital as it has a direct impact on the results of the study.
Can You Use More Than One CRO in Clinical Trials?
The short answer is yes. In fact, using multiple CROs for a clinical trial is a common scenario in the field of clinical research.
The main reason why you might need to use more than one CRO is due to the geographical scope of the study, as well as the need for specialised services. For example, a sponsor could hire a CRO specialising in regulatory and compliance services and hire another for medical and biotechnology knowledge. The level of expertise varies for each task and the team that can offer such expertise are what you need.
Large international studies typically employ CROs for every geographic location involved in the study. There is an option to hire a full-service CRO that can offer all of the specialised services needed for the study to eliminate the need to hire multiple CROs.