@jauhar123 | Posted 12 Jun. 2019
A Contract Research Organization, also described as Clinical Research Organization (CRO) is a service organization that assists the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical investigation services (for both drugs and medical devices). CROs range from large, worldwide full-service organizations to small, niche specialty groups and can allow their customers the experience of moving a new drug or material from its conception to FDA marketing support without the drug sponsor having to maintain a staff for these services.
Organizations and businesses that contract by CROs do so to acquire specific expertise without obtaining permanent staff. CRO trade associations claim that when firms or public things outsource to a CRO, it decreases the time it takes to manage a trial versus doing the testing in-house, and that changes to significant cost savings. A contract with an external company means that the hiring organization does not require the infrastructure, office space, or human resources to run these trials themselves. The main functions needed for conducting clinical research which are regularly n the departments of clinical research organization are:
1. Medical Function: People working in this field are medically qualified people who improve to design a clinical study, support to develop clinical trial protocols, and present medical related input throughout the study. This involves designations such a medical monitor, medical advisor, clinical research physician, etc.
2. Regulatory submission team: This team or staff assists in submitting various documents and getting approvals from regulatory authorities like the DCGI. An expert regulatory affairs person is a very significant person in the clinical research organization.
3. Clinical Operations: This team is usually the highest in a clinical research organization. It consists of clinical study associates, project managers, clinical trial partners, etc. This is the team which decides clinical trial sites, conducts monitoring at sites, assists in research closeouts, and helps in overall research management. Well, it also used in Pharma Manufacturing.
4. Data Management: A data management team supports in designing different tools and databases to collect data. Again this is a significant team of the contract research organization. They help ensure that the data obtained from clinical trials is clean and ready for analysis. To obtain this, they use sophisticated software like SAS PheedIT, Oracle Clinical, Open Clinica, etc.
5. Biostatistics: Biostatistics team serves to explain the study data as per the protocol and to figure out whether the research has yielded positive or negative results. They help to create statistical tables, figures, and graphs with their interpretations, which are then moved on to the medical writers for compiling into a report.
6. Medical Writing: Medical writers improve write study results in a way which can be followed by the general public. They help writing study reports, writing promotional material, study protocols, etc.
7. Quality Assurance: This section conducts audits to ensure all guidelines, regulations, and regular operating procedures were followed. This department is useful for the overall quality of the organization.
8. IT Team: IT support team is a part of all CROs. They take care of IT related requirements like purchase and maintenance of desktops, laptops, telephones, servers, software’s, etc.