The Role Of A Clinical Data Manager

Every clinical trial generates abundant amounts of data like patient reports, medical history, age, gender, consent forms, laboratory notes, trial design, dose regimen, transcriptions copies, and much more. With such immense of data, and each piece being so important, it is highly crucial for all this data to be completely organized. Databases that are specially designed for the particular set of trials are used to achieve this.

The data is entered into the database and stored in a rows and columns format, after which it is checked for any discrepancies, which are then corrected. This data is then analyzed using statistical analysis methods before being presented to the concerned authorities. This entire process of data collection, integration, and validation is collectively known as clinical data management; and the person responsible to execute this role is known as clinical data manager.

Is Clinical Research A Curse Or Blessing?

Clinical research involves experiments conducted on human beings to evaluate the efficacy and safety of new drugs, new drug delivery systems, and medical devices. Because of the vast geographical and biological diversity, lower trial costs, faster recruitment rate, and a large number of patient population, India has become a hub for conducting clinical trials. Every year large pharmaceutical companies are coming up with newer elements that help to develop better, safer, and more effective drugs in the market. And, to make sure that these drugs are not only useful, but also safe, it is vital to test the same on a group of humans first, before putting out the drug into the market. The human body is unique, and no computer generated model or animal can accurately determine the effect of drugs on humans. This is why it is imperative to check the effect of drugs on humans. But, there are many who consider such experimenting and research as a wrong doing.

What Has Helped Attract New Clinical Trials In India?

The Drug Controller General of India (DCGI), along with the Central Drugs Standard Control Organization (CDSCO), is responsible for the approval of licenses of specialized categories of drugs in India, which include blood products, vaccines, IV fluids, and sera. It is the DCGI who lays down the standards and quality of manufacturing, selling, importing, and distributing drugs in India.

For a long time, India has been out of the list for sponsors to invest in conducting clinical trials in India because of lots of uncertainties and losses. But, the changes brought to the guidelines and standards of drug manufacturing, importing, and selling in India by the DCGI recently has helped India again gain momentum for clinical trials. Here are the recent updates by DCGI that have helped attract new clinical trials in the country.