A contract research organizations (CRO) in the life sciences is a company that outsources research tasks to the pharmaceutical, biotechnology, and medical device industries. Among other things, a CRO might offer commercialization, clinical development, clinical trial management, pharmacovigilance, outcomes research, and real-world evidence.
CROs are formed to reduce costs for companies developing innovative treatments and pharmaceuticals for particular markets. They hope to make medicine development and market entry easier since large pharmaceutical businesses no longer have to conduct everything “in house.” CROs, like governmental entities (such as the NIH and EMA), offer financing for foundations, research institutions, and universities.
Many CROs focus on assisting with clinical trials and research for drugs and/or medical devices. However, the trial’s sponsor is still in responsible of monitoring the CRO’s performance. CROs might be large, worldwide full-service firms or small, specialized enterprises.
Clinical-trials-focused CROs may provide their clients the know-how to take a new medicine or technology from conception to FDA/EMA marketing approval without requiring the drug sponsor to have a staff on standby to deliver these services.
However, CROs should exercise care since they are continually striving to broaden their knowledge, and success in one area cannot foretell success in other areas that may be new to the company. Organizations that have had success working with a certain CRO in a given context (such as the therapeutic domain) may be enticed or urged to broaden their participation with that CRO into unrelated areas.
Definition and legal implications
The International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, a 2015 Swiss NGO of pharmaceutical corporations and others, defines a contract research company (CRO) as “a person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of the sponsor’s trial-related duties and functions.”
The following are the sponsor’s duties as specified in its good clinical practice guidelines:
- (5.2.1) Although a sponsor may outsource any or all of their trial-related tasks to a CRO, the sponsor is ultimately accountable for the trial data’s accuracy and integrity. The CRO should establish quality assurance and quality control.
- (5.2.2) Any trial-related tasks and responsibilities assigned to and assumed by a CRO should be documented in writing. Any trial-related duties and obligations done on behalf of the sponsor, including those assigned to a separate party by the sponsor’s contracted CRO(s), should be overseen by the sponsor.
- (5.2.3) The sponsor retains responsibility for all trial-related actions and obligations that have not been specifically allocated to and assumed by a CRO.
- (5.2.4) Any references to a sponsor in this guideline also apply to CROs inasmuch as a CRO has taken on the obligations and functions of a sponsor in relation to a trial.
According to the US FDA’s 2013 guideline, it is the sponsor’s responsibility to oversee the CRO’s actions, especially when risk-based monitoring has been allocated to the CRO. In 2021, the criteria for alerting the US FDA about CROs and how they “comply with FDA regulations” changed significantly.
Market size and growth
Despite growing consolidation trends, there were more than 1,100 CROs in the globe in 2013. While some CROs have gone out of business, many others have been acquired. In 2008, the top ten companies owned 56% of the market, and 55% in 2009, reflecting the industry’s fragmentation. The global CRO market was worth $38,396.4 million in 2018 and is expected to increase at a 11.4% CAGR to $90,926.3 million by the end of 2026.
Top CROs by revenue sourced creatively
R&D spending grew by 15.5% from 2015 to 2020 as of 2016. Contract research firms include the following well-known companies from throughout the world:
- Labcorp (sales of $14,000,000,000 in 2020)
- IQVIA (2020 revenue: $11.35 billion)
- PPD, Inc. (2020 revenues of $4.68 billion)
- Syneos Health earned $4.41 billion in sales in 2020.
- ICON PLC (2020 sales of $2.79 billion)
- Parexel generated $2.44 billion in revenue in 2017.
- Charles River Laboratories ($2.92 billion in sales in 2020)
- Wuxi Apptec ($1.01 billion in revenue in 2017)
- Medpace ($0.92 billion in sales in 2020)