1. Introduction
A clinical research organization (CRO) is a company that provides support to pharmaceutical and biotechnology companies in the form of research services outsourced on a contract basis. A clinical research organization may provide services such as drug discovery, preclinical and clinical research, development, and marketing.
The global clinical research market was valued at $32.3 billion in 2016 and is expected to reach $52.6 billion by 2025, growing at a CAGR of 6.2%. The increase in the number of clinical trials and the outsourcing of clinical trials by pharmaceutical and biotechnology companies to CROs are the major factors driving the growth of the clinical research market.
In a clinical trial, a CRO is responsible for the management and execution of the trial, from start to finish. This includes the development of the protocol, recruitment of patients, data collection and management, and analysis of the data. A CRO may also be involved in the development of the therapeutic product itself.
The use of CROs allows pharmaceutical and biotechnology companies to outsource the costly and time-consuming process of clinical research, while still maintaining control over the direction of the research. This can lead to faster development timelines and reduced costs.
CROs can be classified into two types: full-service CROs and specialty CROs. Full-service CROs offer a complete range of services, from drug discovery to post-marketing surveillance. Specialty CROs, on the other hand, focus on specific phases of clinical research or specific therapeutic areas.
The global CRO market is highly fragmented, with the top 10 CROs accounting for less than 30% of the market. The top CROs in the world are Vial, PRA Health Sciences, INC Research, and Covance, which collectively hold a market share of 9.8%.
2. What is a Clinical Research Organization?
A clinical research organization (CRO) is a company that provides support to pharmaceutical and biotechnology companies in the form of research services outsourced on a contract basis. CROs play a vital role in the drug development process, helping to bring new treatments to market faster and more efficiently.
CROs offer a wide range of services, from pre-clinical research and development to clinical trials management and post-marketing surveillance. In recent years, the CRO industry has undergone rapid growth and consolidation, as pharmaceutical companies have increasingly outsourced drug development activities in an effort to reduce costs and improve efficiency.
The global CRO market is expected to continue to grow in the coming years, reaching an estimated value of $64.8 billion by 2025.1 The Asia-Pacific region is expected to be the fastest-growing market, with a CAGR of 9.6% from 2018 to 2025.
“Clinical Research Organizations (CROs) Market Size, Share & Trends Analysis Report By Service (Pre-Clinical, Clinical, Post-Marketing), By Region (North America, Europe, Asia Pacific, MEA), And Segment Forecasts, 2018 – 2025” Grand View Research, Inc.
3. The Top Contract Research Organizations
The clinical research industry is booming. The global clinical research market is expected to reach $64.8 billion by 2025 from $34.2 billion in 2016, at a compound annual growth rate (CAGR) of 7.4%.
There are many reasons for this growth. First, the number of new drugs being developed is increasing. In 2018, there were 1,091 new drugs in clinical trials, up from 881 in 2016. Second, the number of clinical trials is also increasing. In 2018, there were 243,836 clinical trials ongoing, up from 219,175 in 2016.
This increase in clinical research is good news for contract research organizations (CROs). CROs are businesses that provide services to support the clinical research process. These services can include anything from managing clinical trials to conducting research to writing clinical study reports.
The top CROs in the world are:
1. IQVIA
2. Parexel
3. Charles River Laboratories
4. Laboratory Corporation of America
5. ICON
6. Covance
7. Evotec
8. inVentiv Health
9. Envigo
10. PRA Health Sciences
11. Vial CRO
4. What Services do these Organizations Provide?
There are a variety of services that clinical research organizations (CROs) can provide to their clients. The most common services include:
1. Clinical Trial Management: CROs can manage all aspects of a clinical trial on behalf of their clients, from start to finish. This includes tasks such as study design, protocol development, site selection, patient recruitment, data management, and statistical analysis.
2. Regulatory Affairs: CROs can help their clients navigate the complex regulatory landscape for clinical trials. This includes assistance with submissions to regulatory agencies, as well as developing and implementing strategies for compliance.
3. Quality Assurance: CROs can provide quality assurance services to help ensure that clinical trials are conducted in accordance with Good Clinical Practices (GCPs). This includes auditing study sites and reviewing data for accuracy and completeness.
4. Project Management: CROs can provide project management services to help their clients plan and execute clinical trials. This includes developing timelines, budgets, and milestones for trials, as well as coordinating the activities of all involved parties.
5. Business Development: CROs can help their clients identify and pursue business opportunities in the clinical research arena. This includes identifying potential partners and customers, as well as providing market analysis and trend tracking.
CROs can provide a valuable service to their clients by helping them to navigate the complex and ever-changing landscape of clinical research. By leveraging the expertise and experience of a CRO, sponsors can focus on their core business goals and objectives, while ensuring that clinical trials are conducted in a safe, ethical, and compliant manner.
5. Why are these Organizations Important?
1. They improve the quality of healthcare
2. They help to advance medical knowledge
3. They promote collaboration among healthcare professionals
4. They provide opportunities for training and education
5. They improve patient safety
6. What are the Benefits of Working with a Clinical Research Organization?
A clinical research organization (CRO) is a company that contracts with pharmaceutical and biotechnology companies to provide services related to clinical trials. These services can include study design, patient recruitment, data management, and statistical analysis. CROs can be small, specialized companies or large, full-service organizations.
There are many benefits to working with a CRO. First, CROs have a deep understanding of the clinical trial process and can help sponsors navigate the regulatory landscape. Second, CROs have extensive experience managing clinical data and can provide high-quality data analysis. Third, CROs can help sponsors save time and money by streamlining the clinical trial process.
Working with a CRO can also help sponsors mitigate risk. CROs can help identify potential risks and develop strategies to mitigate them. Finally, CROs can provide peace of mind to sponsors by taking on the day-to-day management of the clinical trial.
There are many reasons to consider working with a CRO. CROs can help save time and money, minimize risk, and provide peace of mind. If you are considering a clinical trial, partnering with a CRO may be the best decision for your company.
7. How to Choose the Right Clinical Research Organization
There are a number of factors to consider when choosing a Clinical Research Organization (CRO). Here are seven key considerations:
1. Experience and expertise
The first consideration is the experience and expertise of the CRO. Make sure they have experience in the therapeutic area you are researching and that they have a good understanding of the regulatory landscape.
2. Size and scope
The size of the CRO is also important. You want to make sure they have the resources and capacity to handle your project.
3. Location
The location of the CRO is also a consideration. You may want to choose a CRO that is close to your research site or that has a presence in the country where your research will be conducted.
4. Cost
Cost is always a consideration when choosing a CRO. Make sure you get quotes from a few different CROs and compare their fees.
5. References
Make sure you get references from the CROs you are considering and speak to other companies that have used their services.
6. Contract
Be sure to review the contract carefully before signing anything. Make sure you understand the terms and conditions and that you are comfortable with them.
7. Communication
Finally, communication is key. You want to make sure you have a good working relationship with the CRO and that they are responsive to your needs.
Read also: Top 10 CROs to Watch in 2023
8. Conclusion
A clinical research organization (CRO) is a company that provides support to pharmaceutical and biotechnology companies in the form of research services outsourced on a contract basis. A CRO can perform all or some of the clinical development phases of a new drug or medical device.
The global clinical research outsourcing market is expected to reach $64.8 billion by 2025 from $32.9 billion in 2020, at a CAGR of 14.1%. The growth of this market is mainly driven by the outsourcing of clinical trials by pharmaceutical and biotechnology companies, the increasing number of clinical trials, and the rising demand for cost-effective clinical research.
The top CROs in the world are Vial, QuintilesIMS, Parexel, ICON, Covance, and Charles River Laboratories. These companies together accounted for a share of approximately 58.0% of the global CRO market in 2013. The clinical research outsourcing market is segmented by phase, therapeutic area, service, end user, and region.
On the basis of phase, the clinical research outsourcing market is segmented into phase I, phase II, phase III, and phase IV. The phase III segment is expected to grow at the highest CAGR during the forecast period. This growth can be attributed to the fact that phase III trials are the most critical and expensive phase of clinical development and are essential for the approval of a new drug by the FDA.
On the basis of therapeutic area, the clinical research outsourcing market is segmented into oncology, neurology, cardiology, infectious diseases, and others. The oncology segment is expected to grow at the highest CAGR during the forecast period. The high growth of this segment can be attributed to the rising incidence of cancer, the increasing number of cancer clinical trials, and the availability of government funding for cancer research.
