Large pharmaceutical companies increasingly are using “downsizing” strategies to be able to concentrate their resources on core skills and specialties.
Clinical research organizations (CROs) are service organizations that provide research and support services to pharmaceutical, biotechnological, and healthcare companies. According to the Code of Federal Regulations, the U.S. FDA regulations state that a CRO is "a person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration". CROs were born to fill a demand for innovative organizations whose routines and competencies vary from the pharmaceutical companies. Lack of in-house capacity, skill deficiency, and cost control are some reasons of outsourcing to CRO.
The CRO population gradually increased in recent years. The main reason behind this growth is the specialization and the creation of niche
CRO service providers. Today, the industry is evolving more toward a full-service model, with offering services from the earliest stages of development through clinical trials and post-approval research.
The process of drug development needs refined expertise and an extensive arrangement of medical and laboratory expertise including disease target identification, preclinical evaluation, toxicology and safety testing, clinical trial design and implementation. The research and development (R&D) process of every new drug is complex and lengthy. The time span between the drug discovery phase and the FDA approval can take up to 15 years. For every 5,000-10,000 therapeutic potential new compound evaluated, ultimately only one receives approval from the FDA. So, discovering and developing safe and effective drug is a challenging task for pharmaceuticals, which takes around 10-15 years, costing $1.0 to $1.5 billion.
In recent years, three regions have emerged as “hot” up-and-coming CRO markets: India, China, and Central and Eastern Europe. India has been conducting global studies for over 30 years. Several guidelines provided the framework for clinical trial in India which includes the Indian Good Clinical Practice, the
Indian Council of Medical Research ethical guidelines and Schedule Y. Regulatory authorities are also concerned about the accuracy, validity and safety of research participants. The drug formulator has had to change the way drugs are developed in order to ensure better patient safety.
The major role of a CRO is to fill the gaps in the in-house capacity of pharma and biotech companies including major services like organic synthesis, analytical chemistry, biochemistry, molecular modeling, and medicinal chemistry to
clinical research trials. CRO core services should include: research model production and services, discovery services, toxicology studies, bioanalytical services, central laboratory, investigator and patient recruitment, site monitoring, data management services and technology, safety and pharmacovigilance, study and development program design and consulting, regulatory affairs advisory and a variety of post-marketing surveillance and consulting services.
At present, full-service CROs offer a broader range of services including the selection of investigators and investigational sites, assistance with patient recruitment, safety surveillance and reporting, site audits, and clinical trials data management and biostatistics. The concept of Expertise-Based Integrated Service (EBIS), which has been well received by the industry, should be the primary motto of the CROs to serve virtual companies and academic spinoffs. Dedicated disease modeling in preclinical conditions of bone/ orthopaedics, inflammation & autoimmune, and oncology have already become driven part of the EBIS on pharmacology.
An ideal CRO should promote quality research, uphold ethics, share best practices, promote synergies amongst members, to deliberate and act upon common concerns, especially with regards to countries regulations and industry environment. Some CROs also help companies guide products through the regulatory process and handle advertising and patents.
