Old School CONTRACT RESEARCH ORGANIZATION
1. What is a Contract Research Organization?
A Contract Research Organization (CRO) is a company that provides support to the pharmaceutical and biotechnology industries in the form of research services outsourced on a contract basis. CROs perform a wide range of services, from drug discovery and development to clinical trials and post-marketing surveillance.
The global CRO market is expected to grow from $27.8 billion in 2016 to $41.5 billion by 2021, at a compound annual growth rate (CAGR) of 8.1%, according to MarketsandMarkets. The growth of the CRO market is driven by the increasing demand for cost-effective drug development, the increasing number of clinical trials, and the shortage of skilled labor.
The top five CRO companies are QuintilesIMS, Parexel, LabCorp, Charles River Laboratories, and Covance, which together account for more than 50% of the global CRO market.
2. The History of Contract Research Organizations
The Contract Research Organization (CRO) industry has its origins in the pharmaceutical and biotech industries. In the early days of these industries, companies outsourced basic research and clinical development activities to academic institutions and research organizations. However, as the industry matured, companies began to bring these activities in-house, relying on their own employees to carry out research and development (R&D).
However, in the late 1970s and early 1980s, a number of factors led to a resurgence of outsourcing in the pharmaceutical and biotech industries. First, the cost of R&D began to rise, as companies increasingly turned to expensive new technologies such as molecular biology and combinatorial chemistry. At the same time, the number of new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) began to decline, from a peak of 53 in 1996 to just 21 in 2006. This meant that companies were spending more on R&D but getting fewer new drugs to market.
In response to these trends, pharmaceutical and biotech companies began to outsourcing more of their R&D activities to CROs. By 2006, the CRO industry was worth an estimated $17 billion, and it has continued to grow in the years since.
The history of the CRO industry is thus closely intertwined with the history of the pharmaceutical and biotech industries. As these industries have evolved, so too has the CRO industry, growing and changing in response to the needs of its clients.
3. The Services Offered by Contract Research Organizations
A contract research organization (CRO) is a company that provides support to the pharmaceutical and biotechnology industries in the form of research services outsourced on a contract basis. CROs offer a wide range of services, from preclinical research to clinical trials and post-marketing surveillance.
The services offered by contract research organizations can be divided into four main categories:
1. Preclinical research services
2. Clinical research services
3. Regulatory affairs services
4. Drug safety and pharmacovigilance services
1. Preclinical research services
CROs offer a wide range of preclinical research services, from in vitro and in vivo studies to drug metabolism and pharmacokinetic studies. In vitro studies are conducted using cell culture systems, while in vivo studies are conducted in animal models.
CROs also offer services related to drug metabolism and pharmacokinetic studies. Drug metabolism studies help to understand how a drug is metabolized by the body, while pharmacokinetic studies help to understand how the body affects the distribution, absorption, and elimination of a drug.
2. Clinical research services
CROs offer a wide range of clinical research services, from clinical trial design and management to data analysis and interpretation. CROs also offer services related to patient recruitment, clinical trial logistics, and regulatory affairs.
3. Regulatory affairs services
CROs offer a wide range of regulatory affairs services, from regulatory strategy and submissions to clinical trial applications and product approvals. CROs also offer services related to post-marketing surveillance and risk management.
4. Drug safety and pharmacovigilance services
CROs offer a wide range of drug safety and pharmacovigilance services, from adverse event reporting and risk management to literature reviews and product recalls. CROs also offer services related to patient safety, product liability, and quality assurance Contract Research Organization.
4. The Benefits of Working with a Contract Research Organization
A contract research organization (CRO) is a company that provides research and development services to pharmaceutical and biotechnology companies on a contract basis. CROs offer a variety of services, including clinical trials, data management, and regulatory affairs.
CROs are an attractive option for pharmaceutical and biotechnology companies because they can provide a cost-effective way to outsource research and development activities. In addition, CROs have expertise and experience in a wide range of therapeutic areas and can offer a flexible workforce that can be quickly ramped up or down as needed.
There are several benefits of working with a CRO, including:
1. Cost savings: CROs can provide a cost-effective way to outsource research and development activities.
2. Flexibility: CROs offer a flexible workforce that can be quickly ramped up or down as needed.
3. Expertise: CROs have expertise and experience in a wide range of therapeutic areas.
4. Speed to market: CROs can help to speed up the process of bringing new drugs and therapies to market.
If you are considering working with a CRO, it is important to choose one that is reputable and has a track record of success. Be sure to ask for references and case studies from previous clients.
5. The challenges of Working with a Contract Research Organization
The clinical research industry is rapidly evolving, and with that comes new challenges for those working with Contract Research Organizations (CROs). Here are five of the biggest challenges faced by those working in this industry:
1. Increasing Regulatory Burden
The clinical research industry is subject to increasing regulatory scrutiny, which means that CROs must be ever-vigilant in ensuring that their processes and procedures are up to scratch. This can be a challenge, especially for smaller CROs who may not have the same resources as their larger counterparts.
2. Access to Talent
The clinical research industry is a highly competitive marketplace, which can make it difficult to attract and retain the best talent. This is especially true for smaller CROs who may not be able to offer the same salaries and benefits as their larger counterparts.
3. Managing Client Expectations
CROs must strike a delicate balance between meeting the expectations of their clients and ensuring that the research is of the highest quality. This can be a challenge, especially when clients are demanding quicker turnaround times or lower costs.
4. Ensuring Data Quality
The quality of data is of paramount importance in the clinical research industry. CROs must therefore ensure that their data is of the highest quality, which can be a challenge given the complex nature of clinical trials.
5. Keeping Up With Technology
The clinical research industry is reliant on technology, which means that CROs must continuously invest in new software and systems. This can be a challenge, especially for smaller CROs who may not have the same budgets as their larger counterparts.
6. How to Choose the Right Contract Research Organization
There are a lot of different factors to consider when choosing a contract research organization (CRO). Here are six of the most important factors to keep in mind when making your decision:
1. Make sure the CRO has experience in your specific therapeutic area.
You want to make sure that the CRO you choose has experience working in your specific therapeutic area. They should have a good understanding of the disease state and the relevant animal models. This will help them design and execute studies that are more likely to produce meaningful results.
2. Choose a CRO that has a good reputation.
There are a lot of CROs out there, so it’s important to choose one that has a good reputation. Ask around and see what other companies have used them and if they were happy with the results. You can also check online reviews.
3. Make sure the CRO is accredited.
It’s important to make sure that the CRO you choose is accredited by a recognized body such as the Association for the Accreditation of Human Research Protection Programs (AAHRPP) or the European Federation of Pharmaceutical Industries and Associations (EFPIA). This ensures that they have high standards and are subject to regular audits.
4. Make sure the CRO has the necessary resources.
The CRO you choose should have the necessary resources to carry out your project. This includes things like staff, equipment, and facilities. They should also have a good network of contacts that they can call on for help with specific tasks.
5. Make sure the CRO is flexible.
You want to choose a CRO that is flexible and able to adapt to your needs. They should be able to tailor their services to meet your specific requirements.
6. Get a proposal from the CRO.
Once you’ve considered all of the above factors, you should get a proposal from the CRO. This will help you compare the different CROs and make the best decision for your company.
7. The Future of Contract Research Organizations
The contract research organization (CRO) industry is forecast to grow at a compound annual growth rate (CAGR) of 8.6% from 2019 to 2026, according to a report by MarketsandMarkets. The growth is driven by the rising demand for outsourced clinical research services, the growing number of clinical trials, and the need to reduce the cost and time of drug development.
The CRO industry is highly fragmented, with the top 10 companies accounting for less than 40% of the market. The industry is expected to consolidate in the coming years as the top companies acquire smaller CROs to expand their geographic reach and service offerings. The industry is also becoming more specialized, with CROs focused on specific therapeutic areas or phases of clinical trials.
The future of CROs is likely to be shaped by the following trends:
1. The continued growth of the biopharmaceutical industry and the resulting increase in the number of clinical trials
2. The need to reduce the cost and time of drug development
3. The trend towards outsourcing of clinical research services
4. The consolidation of the CRO industry
5. The trend towards specialization of CROs
6. The increasing use of technology in clinical research
7. The rising demand for patient-centric clinical trials
The CRO industry is expected to continue to grow in the coming years, driven by the increasing demand for outsourced clinical research services and the need to reduce the cost and time of drug development.