Clinical trials are an essential component for manufacturing products designed for human consumption. This series of trials ensure that the product does not exhibit harmful side effects and its efficacy can compete with the existing products on the market.
Clinical Research Organizations (CROs) offer their services for performing clinical trials in clinical researches for research institutions in various fields like pharmaceuticals and biotechnology.
Clinical trials help in the advancement of technology, especially in the medical field. These trials help experts understand the reactions of the body to a particular medical invention and make alterations based on the results of the phases of the trial. People who participate in these trials may be the first to benefit from the new way of treatment.
Phase 1 of the trial involves a minimal number of people and can involve healthy individuals. This is usually the risky part of the trials because the risks and benefits are still unsure.
Phase 2 of the trial involves a larger group of people. Usually, people who are ill of a targeted disease are the potential respondents for this stage of the clinical trial. In this stage, the scientists will observe the short-term effects of the product.
Phase 3 involves a much larger group of people and can even last for years. Lastly, Phase 4 is for the medicines which are deemed safe according to the previous three trials and can be given a marketing license for mass production.
Clinical trials are time-consuming and can involve using a wide network of resources. Preparing for clinical trials involves various steps from protocol design to independent audits. Clinical Research Organizations (CRO) offer their services primarily for conducting clinical trials.
Clinical Research Organizations (CROs)
The sponsor of clinical research is an individual or group of individuals who control the funding of research. Sponsors may or may not hire clinical research organizations based on the needs of the research. However, for certain types of research, CRO may lift a significant part of the burden of conducting research, manufacturing a product, and selling it into the market.
Sponsors can hire CROs to perform a wide variety of tasks related to performing clinical trials. CROs are independent contractors with resources and specialized knowledge about performing clinical trials. They can plan the research design, coordinate with the sponsors and clinical research assistants (CRA), and execute and supervise the clinical trials.
In 2018, CROs earned an estimated amount of 39 billion dollars and are expected to grow up to 51 billion in 2024. This shows the dramatic growth and relevance of CRO in conducting clinical research. They allow companies to edge the competition and introduce the new medicine into the market the soonest possible at a lower price.
CROs have the expertise, capabilities, and knowledge about the proper conduct of research trials. They can help alleviate some of the burdens for the research sponsor while still maintaining the quality of the research and compliance with research ethics and standards. They help in bridging the invention and release of a drug or medicine into the public. A properly communicating CRO can function as an extension of the sponsor in conducting and finishing the research.
CROs can be considered as an outsourcing company for research institutions including universities, government and non-government organizations, and foundations. They can act as the middleman that links the sponsors of the research organization to research institutions. They give research organizations and sponsors the flexibility of performing trials without requiring permanent staff.
CROs can offer a wide variety of services related to clinical trial management for biotechnology, pharmaceutical, and medical institutions. They can perform biological and chemical testing, formulation, database management, data entry, recruitment data management for patients, and disease coding. They can also create reports on suspected unexpected serious adverse reactions (SUSARs) as well as individual case study reports or ICSRs.
As far as the actual clinical trial is concerned, CROs can initiate and monitor the clinical trial, ensuring following the rules for maintaining the quality of the trials. They can start the clinical trials, revise protocols, provide the necessary documentation, submit the research proposal to the ethics committee for approval, design and prepare case reports, finalize the samples, and negotiate the contract. More importantly, they process and analyze adverse reactions during the clinical studies with proper documentation.
Why Hire CROs?
Hiring a CRO for performing clinical trials can significantly help smaller institutions and firms in releasing their medical product or drug into the market safely. These smaller firms usually do not have enough resources and manpower to organize and finish clinical trials.
CROs do not only have the necessary manpower and machinery, but they also have the necessary knowledge of the various risks in performing clinical trials. The more fluid alignment and integration of processes when employing CROs leads to a lesser waste rate in testing and manufacturing the product. This will lead to lesser delays in releasing the product to the public.
Lesser delays and mishaps also lead to a lower cost of creating and mass-producing the product. The lower overhead cost of hiring CROs to perform clinical trials due to the streamlined testing and production process can significantly help starting firms with original formulation and ideas compete in the market.
However, some CROs may still provide unsatisfactory work. This can potentially lead to several repeat trials which can delay the release of the product to the market. Usually, these delays can cause time and financial losses for the company, which negates the purpose of hiring CROs. Some CROs offer a liability clause in their contract which compels them to assume responsibility for repeat trials.
CROs became a billion-dollar industry because of their expertise in a crucial part of clinical research, clinical trials. Their expertise in this specific field makes them a valuable asset for starting companies that do not have their resources and machinery to conduct clinical trials efficiently.