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Sollers is a graduate school located in New Jersey, specializing in clinical research, drug safety and pharmacovigilance training.

Our graduate certificate and masters programs cover a wide range of subjects tailored to this fast growing industry, and our graduates go on to highly successful careers in the pharmaceuticals industry and healthcare industries.

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Sollers Blog

The Protocol of Clinical Trial Operations

Posted by Doctor Dan on Aug 12, 2016 7:41:36 AM

When a new drug is introduced in the market, it has to go through the standard procedures of going through clinical trials. Many new methodologies using technology are introduced to test and analyze these drugs before they reach the consumers. All standards of safety are practiced to ensure a healthier life for the public.

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What Do Clinical Trials Involve?

When a new or a rare drug is discovered, its effect on the human body is checked. Also, the drug is tested for any adverse effects. All the pharmaceutical methods of manufacturing and storing the drugs are tested for its best use. All the information with regard to the creation of drugs is tested. Clinical as well as non clinical information about the drug is researched; the data is collected before the drug reaches the market.

Standards Are Defined Globally

Good Clinical Practice (GCP) standards are practiced internationally. The guidelines under which these trials are created are focused on protecting human rights. Regulations of these trails are specific to every country. Same practices do not apply in all countries, although, there is a standard procedure of performing common clinical operations. The protocols followed by these trials are strict and health care organizations are to comply and adhere to these standards.

Drug Creation Project

These protocols lay down the ground work of creating a design of the drug or any pharmaceutical products. The drug discovered must be able to solve health problems of the patients. All the documentation involved must state clearly procedures and elements used in detail. All aspects of drug creation are investigated from the beginning to the end. Any discrepancies found, the process is reiterated.

Conclusion

Before new drugs are made available in the market for consumer purchase, they are extensively tested at every stage for quality and adhering to the protocols.

Topics: clinical trial courses, Clinical Trail Management, Clinical Research