The pharmaceutical and biotech industries are witnessing rapid growth and innovation, driving the need for efficient research and development (R&D) processes. Contract Research Organisations (CROs) have emerged as key partners providing outsourced services across various domains such as preclinical services, clinical trials management, regulatory affairs, and more.
Contract Research Organisations, are external service providers that offer specialised support to pharmaceutical and biotech companies. They play a critical role in accelerating drug development, reducing costs, and enhancing operational efficiency for their clients.
Breakdown of main services offered by CROs:
1. Preclinical Services
Preclinical testing, including in vitro and in vivo studies, to assess the safety and efficacy of drug candidates before human trials.
2. Clinical Trials Management
Planning, execution, and oversight of clinical trials, ensuring adherence to protocols, data collection, and regulatory compliance.
3. Clinical Data Management
Collection, validation, and analysis of clinical trial data, ensuring accuracy and compliance with regulatory standards.
4. Biostatistics and Statistical Analysis
Application of statistical methods to analyze clinical trial data, providing insights on efficacy, safety, and patient outcomes.
5. Regulatory Affairs
Expertise in navigating complex regulatory requirements, ensuring compliance with local and international regulations.
6. Pharmacovigilance and Drug Safety
Monitoring, evaluation, and reporting of adverse events and side effects associated with investigational drugs and marketed products.
7. Medical Writing
Preparation of regulatory documents, study protocols, investigator brochures, and other scientific and medical documents.
The global CRO market has experienced significant growth in recent years, driven by increasing outsourcing trends and the need for specialised expertise. According to industry reports, the CRO market was valued at $41.98 billion in 2023, and it is projected to grow to $57.95 billion by 2028 at a CAGR of 6.66%.
