As a fresher or new clinical researcher, we do have a question on our mind that, What is Contract Research Organisation (CRO)? What work CRO’s do?.
Although the first clinical trial is recorded during the biblical times, the roots of the Contract Research Organization (CRO) can be traced back to the late 40s to early 50s. However, the current CRO structure started taking form in the late 70s and early 80s.
The services of CROs started from providing animals to carry out the experiments on drug discovery. Now the CRO is an institute that provides clinical research-related services to organizations like pharmaceutical, biotechnology, medical device industries, universities, foundations, and government institutes.
It is estimated that nearly 50% of CROs work is outsourced clinical studied from the pharmaceutical industries, nearly 27% from biotechnology industries and the rest from other domains.
CROs play a vital role in the clinical research, they work for the organizations by managing and leading the trial duties and other related functions that are involved for the overall development of the clinical trial on the behalf of the organization and also acting as the central contact point for the rest of the bodies involved (e.g. ethics committees, regulatory agencies, vendors, and hospitals).
There are more than 60 CROs in Inida. Read our article on List of CROs in India. The wide-ranging services provided by CROs are:
- Project management Database design & build
- Data entry & validation
- Clinical trial data management
- Medicine and disease coding
- Quality and metric reporting
- Statistical analysis plans and reports
- Validation programming
- Safety and efficacy summaries
- Final study report
By contracting with the CROs with required levels of expertise, the company or the organizations need not hire permanent staff, instead, outsource the clinical trials and its related functions to CROs. By doing this the cost and time savings are improved. They help reduce the workload on the sponsors while ensuring quality and compliance with national and international standards as the requirements. Although the trial function is transferred to the CROs the integrity of the trial data is the responsibility of the sponsor.
Thus, sponsors should carefully assess the particular requirements of their projects, and contract to the CRO that best meets the requirements.
CRO organization can be briefly divided into various departments based on the services and works, which are as follows;
This department involves medically qualified people who work towards designing of the clinical studies, provide relevant medical inputs and clinical trial protocol developments.
Regulatory submission team:
This department has one of the most crucial roles in the clinical study conducted. The team is involved in the submission of relevant documents and obtaining the required approvals from the regulatory bodies.
This team is usually the largest department. It consists of clinical research associates, project managers, clinical trial assistants, etc. They select clinical trial sites, conducts site monitoring, assists in the study, and helps in the overall management of the study.
This department deals with the collection, storage, and organization of data, and also the development of various software tools required for efficient database management.
This department analysis the study conducted as per the protocol and draws a conclusion of the result as positive or negative. They also help in the graphical representation of the obtained data for easy interpretations.
This department is mainly engaged in gathering the related information and generation of trial results in a simpler and efficient format based on the target audience.
This department conducts audits to ensure the overall quality of the trial conducted based on guidelines, regulations, and standard operating procedures which has to be followed.
They are involved in maintaining and providing facilities to all the CRO departments.
Admin and Finance:
The administration and financial works are under this department.
They are involved in hiring based on the requirements in various departments.
Training & Development:
This department focuses on the professional development of its employees by conducting various training on a regular base to ensure its staffs are up to date with recent advances.
CRO Market Analysis Currently the global CRO market is predicted to have a growth rate of 12% and the market is expected to reach a share value worth $44.4 billion by 2021. By the type of service provided the clinical research services hold the largest share in the CRO market due to the rapid growth seen in biologics, biosimilars, and R&D.
The clinical research segment collectively includes Phase I, Phase II, Phase III, and Phase IV. Some of the other major segments of the global CRO market are drug discovery, pre-clinical, clinical research services, laboratory services, and consulting services.
With a set complex regulatory frameworks Drug discovery is the fastest-growing segment as CROs. In terms of therapeutics, cancer is a major cause of death worldwide, oncology segment holds the largest share in the market and other segments being infectious diseases, central nervous system disorders, immunological disorders, cardiovascular diseases, respiratory disorders, diabetes, and others.
Possible drawbacks of working with CROs
• The offshore clinical trials may give rise to ethical concerns.
• The reaction of drugs can be different between different ethnic backgrounds.
• Possibilities of confidentiality loss
• Lose of control over some of the trial process.
Benefits of contracting CROs
Outsourcing clinical trial management significantly lowers the overhead cost and thus helping them make up for the loss due to the lowering of medication prices, which is the major advantage of contracting CROs for the pharmaceutical companies and medical devices organizations.
Other benefits being the easy access of any information related to the project with few clicks due to its unique management system, enhanced billing compliance, efficient regulatory processes, increased staff efficiency, strong financial management, and access to a collaborative community.
Future of CROs post-COVID Termination and withdrawal of nearly 3000 research entries were done during the course of December 2019 to May 2020. There will be a spike in the study activations and enrolment of patients due to the pressure from sponsors and investigators to restart the work.
At the same time, the research center and the health systems will require time to get back to their normal work stage. To overcome the situation the CROs should adapt to newer solutions and additional resources.
I hope i conveyed the answer of your question on What is Contract Research Organisation (CRO)? What work CRO’s do?.
Content Writer : Acquline Cladious