Many students often ask us questions about contract research organizations (CRO’s). As expected, they do not have a complete picture about what the differences are between sponsor companies, contract research organizations, site management organizations etc. Let us give you a brief idea about what a contract research organization does and how it functions!
A contract research organization, sometimes also referred to us a clinical research organization, or CRO is basically a company that helps conduct research for a sponsor company. This research can be anything from pre-clinical development of new products to post marketing research activities.
One of the major guidelines that is followed to conduct clinical research is the ICH GCP guideline. Let us see how this guideline defines a contract research organization. The guideline states that a contract research organization is:
“A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.”
What you must be thinking is why does a sponsor company e.g. a huge pharmaceutical company need a contract research organization (CRO) to conduct its research? …Answers to this question are many however let us focus on some main points. The main reason why a sponsor company uses the services of a contract research organization is that the contract research organization specializes in conducting research compared to pharmaceutical companies who themselves are busy in a number of other activities like basic R&D, sales and marketing. A contract research organization brings in a lot of value to the pharmaceutical or biotechnology sponsor company by saving costs and also helping reduce the time period required to conduct the clinical trial. Outsourcing research activities especially clinical research to contract research organizations helps sponsor companies to focus on other activities within their organization Outsourcing helps sponsors convert the fixed costs of maintaining the personnel, expertise and facilities necessary for clinical trial management into variable costs. Sponsors may also outsource clinical trials if they do not have complete know how of regulatory affairs in a particular country of interest or if regulations require them to have legal presence in that country to be able to conduct clinical trials.
A contract research organization (CRO) can work with a number of sponsors who can be referred to a clients. A good CRO has well qualified, experienced and skilled staff, and can provide all services to the client in relation to the research project / clinical trial. What services are we talking about when we say ‘all services’? Well, as you are aware conducting clinical research is a complex process which requires a large team of people with different skill sets and experience to perform different functions. The main functions required for conducting clinical research which are usually also the departments in a clinical research organization are:
1. Medical Function: People working in this area are medically qualified people who help to design a clinical study, help to develop clinical trial protocols and provide medical related input throughout the study. This includes designations such a medical monitor, clinical research physician, medical advisor etc.
2. Regulatory submission team: This team or department assists in submitting various documents and obtaining approvals from regulatory authorities like the DCGI. An experienced regulatory affairs person is a very important person of the clinical research organization.
3. Clinical Operations: This team is usually the largest in a clinical research organization. It consists of clinical research associates, project managers, clinical trial assistants, etc. This is the team which selects clinical trial sites, conducts monitoring at sites, assists in study closeouts and helps in over all study management.
4. Data Management: A data management team helps in designing various tools and databases to collect data. Again this is an important team of the contract research organization. They help ensure that the data collected from clinical trials is clean and ready for analysis. To achieve this they use sophisticated software’s like Oracle Clinical, SAS PheedIT, Open Clinica etc.
5. Biostatistics: Biostatistics team helps to analyze the study data as per the protocol and to figure out whether the study has yielded positive or negative results. They help to generate statistical tables, figures and graphs with their interpretations which are then passed on to the medical writers for compiling into a report.
6. Medical Writing: Medical writers help write study results in a way which can be understood by general public. They help writing study reports, study protocols, writing promotional material etc.
7. Quality Assurance: This department conducts audits to ensure all guidelines, regulations and standard operating procedures were followed. This department is responsible for the overall quality of the organization.
8. IT Team: IT support staff is a part of all CROs. They take care of IT related needs like purchase and maintenance of desktops, laptops, servers, telephones, software’s etc.
9. Admin and Finance: This team takes care of all administration and finance related work. Now you know where the salary comes from :-).
10. Human Resources: All major CRO’s have a dedicated human resources team. They are ones responsible for hiring new staff and developing measures to retain talent pool in the organization.
11. Training & Development: This is a dedicated department in all major CROs. This department / team focuses on the professional development of its employees and conducts routine trainings to ensure that the staff remains skilled and up to date with recent advances.
We hope this post has given you some understanding in terms of why sponsors use services of contract research organizations such as Clinexa Life Sciences, how they operate and what the main departments / functions in a CRO are.