A Clinical Research Organization (CRO) is also known as Contract Research Organization are biotechnology, pharmaceutical, and medical research companies or industries that outsource research services in the form of contracts.
Many contract manufacturing companies provide such services. They help the sponsor company in conducting researches or do it for the company. The services CRO provides are commercialization, clinical research, preclinical research, biologic assay development, clinical trial management, biopharmaceutical development, and pharmacovigilance. CROs mainly reduce the cost of companies that are developing new medicine or drugs in the niche market.
Along with government organizations, they also support universities, research institutions, and support foundations. CROs range from small, niche specialty to large international full-service organizations.
One of the main reasons for sponsor companies take help of Clinical Research Organizations is because of the specialization and expertise they have in various biotechnology or pharmaceutical departments.
Additionally, they reduce the cost and the time required to conduct the research as well as add value to the sponsor company. As a result, the companies get to focus on other aspects and invest their resources in them. Another reason sponsor companies choose contract manufacturing companies in situations or for research operations they do not have complete knowledge of regulatory affairs and other legal aspects.
There various departments in the Clinical Research Organization. These departments also refer to the multiple functions a CRO performs. They are:
- Medical Function: This department involves medically qualified or designated people to work in the designing of clinical studies, provide medical the relevant input, and develop the clinical trial protocols. People with designations such as medical advisor, medical monitor, clinical research physician, etch are qualified to carry out the medical functions.
- Regulatory Submission Team: They are one of the most important people in the CRO. The team takes care of all the submissions of documents and getting approvals from the regulatory authorities.
- Clinical Operations: It is the largest department that consists of project managers, clinical research associates, clinical trial assistants, and more. It selects the sites where clinical trials can be conducted, conducts monitoring at the locations, and helps in the study of overall management.
- Data Management: The data management team is an important department that helps in building or designing tools and databases to collect data and store it. The department makes sure that the data taken from the clinical trials is clean and ready for analysis. Some of the software they use are SAS PheedIT, Oracle Clinica, Open Clinica, and so on.
- Biostatics: This team analysis the study data according to the protocol and sees if they yielded positive or negative results. They generate graphs, statistical data, tables, charts, and figures with their interpretations.
- Medical Writing: Medical writers take all the data from the biostatics department and then compile them into reports that will be easy for general people to understand. Along with that, also help in writing study reports, protocols, promotional material, and more.
- Quality Assurance: The department ensures the overall quality of the entire quality of the organization. They conduct audits to ensure that all the guidelines, standard operating procedures, protocols, and regulations are followed. Check out the contract manufacturing companies that offer the services as per the organization’s or research’s requirements.
- IT Team: The IT team looks after all the It-related activities such as the purchase of monitors, desktops, or computers and also their maintenance.
- Admin and Finance: The department handles all the work involving administering and financing.
- Human Resources: The human resources team looks after recruitments and hiring of new people, and also develops measures to add to the growth of the organization.
- Training & Development: This department conducts regular training sessions for the employees and ensures to keep them up to date on the latest developments in their respective fields of study.