A contract research organisation provides research opportunities and services to medical and pharmaceutical companies. Usually, a contract agreement is signed between two entities to aid research work. They are being hired extensively for performing specialised research tasks for another company that sponsors the trial.
Emergence of contract research organisations
Initially, the CRO’s started functioning when they were hired by medical and pharmaceutical companies for managing several aspects of clinical trials. However, today they conduct more complex tasks in the field of biotechnology, pharmakinetics, pharmacodyamics, and tissue engineering. They offer specific services related to pre-clinical, laboratory, and clinical services.
Services they offer
Contract research organisations inIndia provides a flurry of services to biotechnology, pharmaceutical, and medical device companies. There are
· Special CRO’s focusing on specific function areas like data management and statistical analysis
· Full-service organisations catering to different phases of clinical research
Here are the services they provide:
1. Biostatistics
Biostatistics play a big role when it comes to design, analysis, and interpretation of data related to clinical trial. From calculating the sizes of samples, development of TFL shell, justifying them to CRF ad mock tables, and finally the preparation of clinical report, the range of duties they perform is comprehensive.
2. Clinical operations
Clinical operations define the success of a trial, and the services here include clinical and medical monitoring, project management and selection of a site.
3. Data management
Contract research organisations in India assist biotechnology and pharmaceutical industries to manage, collect, ad analyse the data related to clinical trial. For this purpose, they often rely on high-end software and make sure that the data entered is precise and accurate.
4. Medical writing services
They also assist companies to pen clinical trial reports and various other documents related to regulation. These organisations ensure that the documents are not only brief and succinct and also comply with the regulations.
5. Regulatory compliance
With the intervention of CRO’s, biotechnology and pharmaceutical companies understand how significant it is to comply with the regulatory requirements. They have the expertise and knowledge of the guidelines these companies need to follow to meet the regulations.
6. Pharmacovigilance services
Pharmacovigilance ensures the effectiveness and safety of medications through their lifecycle and ensure that they continue to benefit the users.
Why work with a contract research organisation?
The scope of work of contract research organisations in India depend on the requirements of clinical trials. On a broader perspective, pharmaceutical and biotechnology companies leverage the expertise and knowledge of a CRO related to different geographical and regulatory requirements. That way, they benefit from the partnership and expect positive outcomes from the collaboration. Here is why a company needs to work with a CRO:
· Making research more affordable and timed
One of the most significant benefits of working with a contract research organisation is that it makes the clinical trials more affordable and timed. Clinical trials are usually complex and takes about three to six years to get over, during this tenure, the organisations conducting the trial needs to employ resources and experts related to the functionalities,. Now, assigning this task to a third-party organisation instead of recruiting resources in-house makes the entire process cost-effective. Usually, the CRO’s have the resources and infrastructure to manage the trials efficiently.
· Experience and skills
Leveraging the knowledge and experience of a contract research organisation in India is what biotechnology and pharmaceutical companies look forward to. They usually have experience in biostatistics, data management, regulatory compliance, and clinical research.
· Range of services
The services the CRO’s offer to the drug companies is infinite like data management, managing clinical trials, and working with regulatory compliances. Naturally, the pharmaceutical and drug companies can use these services and need not employ resources. Besides, they also offer lab and imaging facilities.
7. Mitigate risks
While working with CRO’s, medical companies can successfully mitigate risks associated with clinical trials. Comprising a team of experts who know how to overcome the complex challenges associated with this field and minimise the emergence of unexpected issues.
The contract research organisations are clearly the point of contact between clinical trials and the companies hiring them for conducting those trials. With a wide range of services they offer, the clinical trial process is greatly streamlined.
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FAQ
· How to choose a contract research organisation?
The criteria for choosing a CRO is judging the experience, knowledge, patient recruitment, geographical coverage, technology, financial capacity, and quality management.
· Why should you hire a CRO?
The primary reason to hire a CRO is to compensate for limited resources of the sponsor. With them, the sponsor can access a wide range of services to streamline the clinical programme.
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