A Contract Research Organization or CRO is essentially a company that manages and leads certain specific research functions for another company (mostly pharma, cosmetics, and food) based on a contract. Companies availing CRO services usually do not hire permanent staff or acquire the specific expertise needed to carry out all the functions of the particular assignment. The responsibility of successfully carrying out a research project becomes the aim of the CRO. Hence, a Clinical Research Organization can significantly reduce the time and cost of conducting trials versus an in-house trial.
What are CRO Services?
CRO provides support to industries that require research and laboratory services. The services are outsourced on a contractual basis for biotechnology, pharmaceutical or medical industries. CRO services are available for preclinical research, clinical research, biologic assay development, clinical trial management, commercialization, and biopharmaceutical development. CROs offer specific services under different kinds of research. The different types of comprehensive services include:
- Data entry and validation
- Metric and quality reporting
- Project management
- Management of critical data
- Coding of medicines and diseases
- Plans and reports of statistical analysis
- Database build and design
- Validation programming
- Summaries of safety and efficiency
- Final study report
Are CROs Cost-effective?
Outsourcing the research functions means that the company does not need to have and maintain an office space, required infrastructure or workforce to handle the trials themselves. Many CROs handle all aspects of medical research, including preclinical and clinical trials. This includes the selection of sites to the enrolment of patients up to the final stage of FDA or EMA approval. This is extremely crucial for companies as it saves the time required for handling the technicalities of medical research. However, even if the responsibility of the trial is shifted to a Clinical Research Organization, the onus for the integrity of research, and data remain with the sponsor.
Performance of the CRO Sector
CROs have come a long way in very little time considering they hardly existed even a decade ago. As medical device organizations and pharmaceutical houses face the pressure of increasing drug costs, outsourcing research requirements presents a great alternative. It reduces overhead costs and ensures that they do not lose out on the profit due to lower costs of prescription drugs. CROs have presented a more affordable outlet for companies that want to pursue and work on new medications.
Earlier even the approval to pursue a drug or treatment was prohibitively expensive. It was only available when it was accompanied by a guaranteed approval for strong demand and a large market base. The cost-effective operation of CROs has allowed pharmaceutical companies to develop rare and smaller drugs and treatment methods for niche audiences. There is an increased presence of CROs in the market. Companies are gearing up to make the best use of the opportunity. And, CROs are also evolving to meet the demands of a new, global economy. Keeping the best interests of both the patients and the shareholders, CROs continue to stress on excellence adhering to GLPs and regulations in their field.