How is a clinical research organization useful in the pharma industry?
A clinical research organization conducts clinical trials and testing on drugs developed by the pharmaceutical companies before they’re introduced into the marketplace for commercial use.
Following are the phases of a clinical trial:
• Phase 0: small dose of a drug on limited number of in-patients
• Phase I: observing the consequences of various drug dosage on a gaggle of 20-40 people to seek out the perfect dosage capacity
• Phase II: trial to guage and compare the effect of the new drug as compared to the effect of existing drugs for an equivalent medical condition. This phase is usually administered on a wider scale (~3000 participants)
• Phase III: trial after FDA approval of the drugs . It involves thousands of participants and may last for years.
Apart from testing for the effectiveness of a drug, a clinical research organization also offers the next services to varied pharma and biotechnological companies:-
• Quality control
• Regulatory management
A majority of the time, pharma companies prefer to outsource to those clinical research organizations as a strategic move to scale back their internal R&D time and costs. Clinical Research Organizations services are already equipped with state of the art laboratory facilities that ensure top-class and credible testing, thus providing quality assurance.
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