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Contract research organizations (CROs) are vendors that focused R&D functions for the pharmaceutical or biotech industry. They are more mistake-proof, well-experienced professionals that offer a variety of services, and are present worldwide. The services including but not limited to drug discovery and development services. For the sponsors, they can transfer any or all of the trial-related duties and functions to a CRO and it is important to select a CRO that fits their style.
The roots of the current CRO marketplace lie back with the foundation of companies like Huntingdon Life Sciences and Charles River Laboratories in the 1940s and 1950s. They provided animal testing services to clients in scientific and pharmaceutical areas. In the late 1970s and early 1980s, the industry began to emerge in its presence that broadened out from the traditional preclinical testing role into clinical trials, data management, statistics, logistics, and other functions. In the late 80s and 90s, the costs in the pharma industry were mushrooming, which provided a niche for the CROs to expand. From the early 1990s to the mid-2000s, the market for CRO services saw explosive growth. During this period, there has been a swarm of mergers and acquisitions in the market. As the market matured, the CRO shifted to play a more long-term role and became more strategic in the services. Many companies can provide one-stop service, from the full range of drug discovery and development, regulatory approval to final healthcare communications. The sponsors could do no work of their own at all but outsource the entire process to CROs.
The global contract research organization market is composed of five parts, including the services, applications, end users, companies, and regional distribution. Among them, CRO services are the foundation and can be further fragmented into consulting services, preclinical and clinical services, early phase development services, laboratory, and data management services. In 2020, the global CRO market was valued at USD61.13 billion and show a CAGR of 8.36%, which is expected to reach USD90.92 billion in 2026. As the number of clinical trials increases, clinical research services dominated the market in 2020. The government supports are positively influencing the growth of CRO market. The developments of healthcare industry and various research are also contributing to the expansion of the market. Also, because of the high cost of in-house drug development, CRO is the most economical option for sponsors.
Fig 1. Global Contract Research Organization Service and Market (Fortune Business Insights, 2019)
The contract research organizations are defined and regulated by the Food and Drug Administration (FDA) (21 C.F.R. § 312.3). The FDA makes the CRO companies directly responsible for any sponsor obligations it assumes for studies conducted under an investigational new drug application. To provide and conduct the research, CROs must meet many requirements. Firstly, the manufacture should follow global standard operating procedures (SOPs). It is better to conduct a systematic review to ensure that all employees follow them. Secondly, all participants in the trials should be trained to follow Good Clinical Practice (GCP), local regulations, and other guidelines. Finally, CROs must fulfill quality assurance and quality control requirements.
For CROs, data security is very important in their research, because the sponsors are highly concerned about keeping their data private. The data leaks will impair R&D activities, and reduce trust toward the company. Therefore, CROs need to develop a set of reliable tools to ensure data security, such as web-based document management systems with access control and electronic signatures, electronic data capture (EDC), clinical trial management system (CTMS), and more. At Creative Biolabs, Intellectual Property Protection (IPP) is our lifeline and we will strictly abide by the agreement with the customer.
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