A contract research organization (CRO) is a business model that provides wide-ranging support services to the pharmaceutical industry. The relationship is business, and the contract is for the deliverables. These “outsourced” services help the drug’s research and development (R&D) process. It’s a vital component in aiding clinical trials ranging from the discovery of products to pre-clinical experiments, and clinical trials. CROs have many functional aspects and specialties.
The evolution of the CRO industry:
The CRO during its evolution was considered to be a specialized entity that provided clinical research associates for monitoring investigational sites and offered regulatory support or biostatistical advice. Gradually they started offering a full range of services that included the selection of investigators and investigator sites, assistance with patient recruitment, site audits, data management and biostatistics, safety monitoring, and reporting. This evolving relationship between CROs and the pharmaceutical industry has resulted in the uptake of major regulatory responsibilities and ethical risks by the CRO.
A CRO has its footprint in the industry with the scope and quality of services provided, its integrity to the adherence to the research protocol, regulatory requirements, timelines, validity of data, and the quality of professional working relationships with investigators and institutions. CROs ensure that they maintain strict adherence to the laws, regulations, and industry standards designed for the conduct of clinical trials along with the protection of human subjects and preservation of data integrity.
Advantages that a CRO has to offer:
The benefits of working with CROs include project, data, and resource management, availability of technology, scientific consultations, protocol developments, medical writing, project management, clinical and medical monitoring, rapid study start-up, subject recruitment, accurate and organized site-related documentation, data management, biostatistics, and pharmacovigilance.
Future trends in the CRO industry:
Economics and demography are driving drug development in the developing world. India must tap into this opportunity to build the research skills required to combat its economic disease burden. Various global and local CROs specializing in the execution of research to develop healthcare products operate in India today.
Decentralized clinical trials (DCT) are considered a new normal in the field of clinical research and the CROs have explored its potential to beat the limitations in the traditional randomized clinical trial models. CROs are also in continuous research to streamline the DCT processes by working on standardized protocols and overcoming their challenges through stakeholder engagement.
CROs have also embraced Artificial intelligence (AI) and Machine Learning (ML). They have utilized it to seek a solution to the complexities of data-related limitations and remote patient monitoring. AI and ML have initiated a revolution by introducing innovative ways of data collection and early diagnosis with cost-effective measures and improved efficiency. CROs have integrated AI as a transformative tool in the drug development process. Future endeavors are still needed by the CROs to address the existing regulatory, technical, and administrative challenges, data privacy concerns, and future applications in real-world scenarios. These will aid in extracting the enormous potential of AI in clinical research and the pharmaceutical industry.
As the drug development industry has evolved, CROs have assumed a critical role in the conduct of clinical trials. They always strive to offer quality services by abiding by the rules and regulations of state and federal governments, the international guidelines, and following their standard operating procedures.
CROs hold great promise in the pharmaceutical industry and their demand has increased substantially. They have a huge potential to transform the drug development process and precision medicine to keep pace with the ever-evolving field of medicine and research.
