Clinical Site | Principal Investigator | CRA | CRO

As a general public or in routine, you are familiar with the medical clinics, Pharmacies, Dispensaries, Hospitals, Physiotherapy centres and rehabilitation centres.

You must have heard of the research departments in Universities.

Before the medicines- drugs, medical devices, dental products and dental devices reach the market, there is an extensive procedure and protocol that these items go through before and after its production.

First a formula is developed by the scientist of the university or the one working in a pharmaceutical company or the manufacturing company of the devices. Lots of dummy trials or trials on animals are conducted to come to the point of manufacturing the drug or the device.

Now they need to do the trials on the human beings to collect statistics to show the regulatory authorities like FDI the viability of the product. These trials are done in the set ups like the clinics where necessary infra structure and the equipments for the trials are available. Such a place is called “CLINICAL SITE”. This site has to be under the standard regulatory norms.

The protocol for the trial of a specific product is laid out under the guidelines of FDI. The doctor handling the trial is called Principal Investigator. He works under the team of experts who are trained to handle the trials, subjects (patients), stationery, collection of the data and storage of the records etc. These people are certified and are called Clinical Research Associates (CRAs). One person need to check the compliance. The whole set up is called Clinical research Organization (CRO). The company must be registered with the concerned authority. The studies or the trials are strictly confidential. People, as per the protocol-age , gender,  oral hygiene, condition of the teeth, are called in groups as dictated by the protocol and are paid for taking part in the trial studies.

This is a brief jest of how the Clinical Research or Trials of the drugs, medical devices etc are conducted.

This basically deals with the corporate companies who pay the Clinical Research organization (CRO). The data is submitted to the company who pays for the trials. The company in turn submits the statistics to the Government for approval, after which the product is launched in the market.

The product is still kept under review and can be withdrawn if found erroneous.

Because of my degree in Dentistry, I have been working as Principle Investigator. I am a certified CRA and CRO too.