R&D efforts under the CRO global situation (Arch Organizations) mainly analyze Quintiles, Covance, PPD, CRL, ICON, Parexel, JMDS, Kendle, PharmaNet, and PRA – 10 CRO companies. The data show that there are about 1,100 CROs worldwide primarily engaged in Phase II and Phase III clinical trials. Surveys indicate that before 2007, the top 10 CROs accounted for 56.1% of the market share in clinical trials. At the same time, global CROs are usually international listed companies facing business growth and shareholder pressure.
Small CROs: Small CROs typically have a workforce ranging from a few to dozens of people. These smaller CROs often provide specialized expertise in certain areas of clinical trials or offer niche services for individual trials. Some small CROs can provide a full range of services required for clinical trials. Sometimes these small CROs form alliances with international global CROs and pharmaceutical companies to access global clinical trial business, particularly in specific areas like auditing, statistical analysis, etc. Small CROs are usually led by a single leader whose discretion shapes the company’s strategy. Compared to global CROs, small CROs face less business growth and shareholder pressure but enjoy greater flexibility. Besides providing clinical trial programs similar to larger companies, they also offer price and flexibility advantages that help secure orders. A common issue faced by small CROs is tight funding.
Specialized CROs: Currently, some CROs provide specific services in particular areas, such as medical imaging professional CROs specializing in ECG analysis and judgment. These CRO companies are responsible for unified professional reading and analysis of ECGs, CTs, MRIs in global clinical trials, avoiding discrepancies caused by differences between countries, regions, or hospitals. Additionally, it's worth mentioning interactive voice response CROs. Such companies, through voice guidance, are responsible for hospital random code allocation, patient eligibility verification, drug choice, and reporting serious adverse reactions. Due to technological advancements, the use of interactive response technology is rapidly increasing. Large, global CRO companies generally have these departments. There are also CRO companies specializing in the analysis and verification of Mental Disease Assessment Scales, ensuring accurate diagnosis of mental illnesses, Alzheimer's disease, depression scales through professional training. The drug distribution in large global multi-center clinical trials is a complex project. Some pharmaceutical companies choose to send experimental drugs to specialized CROs responsible for logistics agency, an emerging CRO company due to extensive global multi-center clinical trials conducted in recent years.
CROs providing clinical trial services include trial design and writing clinical research protocols, GCP-compliant clinical research centers and principal investigators, trial monitoring and data management, clinical data management and statistical analysis, and test report writing. In the drug development process, when sponsors decide to outsource to CROs, they should conduct internal analyses on the following aspects: (1) understanding the content and process of clinical trials; (2) implementing clinical trials; (3) whether there are professionals for implementation, such as clinical research inspectors and research nurses, data administrators, biostatistics analysts, and project managers. Whether there is experience and technology in implementing clinical trials, including relevant experience in financial management and project management of clinical trials, such as the organization and execution of clinical trials. Financial management experience mainly refers to budgeting, arranging, and managing the costs of clinical trials. If sponsors lack these professionals and resources, they will outsource related operations and services to CRO companies with clinical trial experience, knowledge of regulations, and quality management. Additionally, R&D outsourcing is not only about reducing costs but also serves as a commercial strategy. Selecting appropriate and long-term cooperation is crucial.
(Written by James Fan, Deputy Director of ICON Clinical Research International Asia Pacific Medical Department, Email: [email protected])
For more articles related to this topic, please refer to China Prescription Drug 2009 Issue 7, Page 88-49.