All about Clinical Research Organization
The pharmaceutical industry is skipping all the spikes and becoming one of the most valued industries in the world.
But before getting out a simple medicine in the market, there are hundreds of process it needs to checks into. The cost of the medicine is at the top of the shelf. Pharmaceutical companies strive hard to cut down the cost of medicine and time [is money]. To make this possible, a company hire a clinical research organization. According to the research, it typically takes whopping one billion dollars to market out a drug in public.
What Is A Research Organization To A Pharma Company?
The word research talks about its covalent bond with Research and Development (R &D). It helps a pharma company or a sponsor company with their research work. The spectrum of research goes from the pre-clinical development of future products to post-marketing research activities.
In terms of a layman, the research organization takes care of the research and safety of a drug to the surveillance of drug safety after releasing in the market. To conduct research, one should follow up with the ICH GCP guideline. Well, it approximately takes up 12 years for a drug to travel from a laboratory to a cabinet. Hence, drugs making is a vulnerable task. The question that lies in the back of the mind of everyone is, “Why a big pharma company hire such research organization?’’ Let’s look over it in the next section.
The Answer to Why.
Big pharma companies have revenue in billions of dollars. So, why don’t they conduct their own research and surveillance? The answer is: It saves a lot of money and time of the company. How can it be possible? Pharmaceutical companies zoom in over the basic R &D but dig up more in the marketing and sales department. To care for research and development, they hire research organizations to conduct clinical trials.
A contract research organization is also called a biotechnology sponsor of the company. The big leaders in the pharma companies cut down their R & D cost by hiring the one and segregating the money on other activities in the company. It also helps the sponsor company to cut down the hiring process for the expertise.
Maintenance cost of the amenities is also shredded down. In the case, a pharma company doesn’t have a deep insight into how regulatory affairs work in a particular country, outsourcing is done to a research organization. Regulatory affairs imply a particular country interest. It also helps the company to have a legal presence in the county.
The contract research organization helps the sponsor company in many ways. To pry it more, a research company got a lot of complex processes. There is a conglomerate of the process that a research organization goes through or are involved in. Well, this industry is also fragmented according to the tier level.
According to reports, 55-60% of the market is controlled by Top 10 companies in the market. The research organization can work with many of the sponsor companies. Let’s look over the paramount departments in the clinical research organization.
These organizations hire clinical people who help them to study and design clinical trials. It is one of the booming industry and got a lot of scope in the present and not to forget, in the future. They can be called a spinal cord of the medical field.
The regulatory affairs for the sponsor company are managed by them. They help them to obtain approvals from various imperative authorities.
Collect And Analyze:
There is a collection of data using various tools. The data management team ensures that the data is clean and helps to analyze it accordingly. There is a special biostatistics team that studies the data and interpret the results accordingly.
The outline of the article concludes that’s it’s a Win-Win situation for the biotechnology sponsors and the pharmaceutical companies.