Introduction
A contract research organization or CRO refers to a company that provides support in the form of research. The research conducted through CRO services can be in one of the following fields:
Biotechnology
Pharmaceutical
Medical device industry
In full a CRO is a company contracted by another organization to help lead and manage their trials, responsibilities, roles, and their function.
Services and Advantages
Some CRO services executed include such things as, but not limited to:
Biologic assay development
Biopharmaceutical development
Commercialization
Preclinical and clinical research
Management of clinical trials
Database design and building
Data entry and validation
Medicine and disease coding
Quality and metric reporting
Statistical
Pharmacovigilance (the identification, detection, assessment, observation, and prevention of side effects of pharmaceutical products)
CROs are useful for companies when developing new drugs and medications as they reduce costs. CROs are able to simplify the development of new drugs and entry into drug markets. They also support governmental organizations, foundations, universities, and research institutions. CROs can range from small specialty groups to large international organizations. They aim to provide support for clinical studies and trials. Those that specialize in clinical trials services of a new drug are present from its conception until it is approved by the Food and Drug Administration (FDA) or by the European Medicines Agency (EMA). Evidently CROs play a crucial role and pharmaceutical companies are continually outsourcing critical functions such as research and manufacturing to CROs.
The number of major corporations that are using CROs in clinical trials and the development of new drugs is increasing. Companies that establish contract with CROs aim to acquire the required expertise without having to hire permanent staff, keeping overhead low. Some CRO trade groups have claimed that contracting with CROs has helped reduce the cost by decreasing the time it takes to conduct a trial. This also means that the company that hires a CRO will not need the required infrastructure, manpower, and office space to conduct these trials. Some CROs can even manage all the aspects in a clinical trial starting from the site and patient selection all the way up until the final regulatory approval.
Regulatory Aspects
The International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH) defined CROs as “a person or organization contracted by the sponsor to perform trial-related duties and functions”. Their guidelines highlight the following:
A sponsor can transfer all their duties and function to a CRO. However, the hiring company will be responsible for the integrity of data acquired from the CRO conducted study. It remains the hiring company’s responsibility to ensure that all the data is factual and backed by science.
CROs should ensure quality control and quality assurance.
All duties and functions transferred to a CRO should be in writing. The hiring company should oversee the duties and functions that are carried out on their behalf.
Duties and functions that are not transferred to a CRO will remain with the sponsor.
Market Size and Growth
The Association of Clinical Research Organizations has estimated that more than half of clinical studies conducted by the pharmaceutical industry have been outsourced to CROs. The most popular field for CROs is therapeutic work including infectious disease, oncology, central nervous system, cardiovascular disease, and metabolic disorders. A further 27% work for within the biotechnology field while the remainder work for governments, foundations, and the medical device industry. The CRO sector is doing extremely well for an industry that just started a decade ago. There is increasing pressure facing medical devices organizations and pharmaceutical companies for the high cost of drugs and they are trying to lower costs without decreasing their profits. One of the best and most common solutions is to outsource clinical trial management as it results in significantly lower overhead costs.
By the year 2013, there were more than 1,100 CROs globally. However, there are many CROs that have gone out of business or that have been acquired. In 2008, it was estimated that the top 10 companies control 56% of the market. A 2007 estimate showed that the market would reach $24 billion in 2010 with a growth rate of 8.5% from 2009 to 2015. In 2016, the research and development spending increased by 15.5% from 2015 to 2020.
Conclusion
CROs are an effective solution as it provides an affordable option for companies to pursue the development and approval of new medication. Before the existence of CROs, this was a hugely expensive endeavor which was only embarked on when the likely hood of regulatory approval was high. With CROs, companies are now able to develop drugs for specific markets.
References:
Contract research organization. Wikipedia. Accessed 7/30/2018. https://en.wikipedia.org/wiki/Contract_research_organization
Stone K. Contract research organizations (CRO) definition. The Balance. Accessed 7/30/2018. https://www.thebalance.com/contract-research-organizations-cro-2663066
