Clinical data management in Bangalore

Clinical data management in Bangalore

Clinical data management in Bangalore

A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ different means to verify the data..

Case report forms are manually filled at site and mailed to the company for which trial is being performed. The data on forms is transferred to the CDMS tool through data entry. The most popular method being double data entry where two different data entry operators enter the data in the system independently and both the entries are compared by the system. In case the entry of a value conflicts, system alerts and verification can be done manually.

The Clinical Data Management has 4 trial phases

Phase 1 Trials:

Phase 1 trials usually deal with investigating the studied drug in a minor number of research subjects who are healthy volunteers. This phase is mainly targeted at identifying the safety, tolerability, and the general mechanism of the action of the drug in humans.

Phase 2 Trials:

The goal of phase 2 trials is to grasp additional understanding of the studied drug's safety and efficacy. It also determines the appropriate dose to be administered to deliver the desired treatment effect while minimizing the safety risk of future research subjects.

Phase 3 Trials:

This phase often exposes more than 1000 research subjects with the disease, and is usually performed at many clinics to enroll the trial. There is a focus on the effectiveness of the study drug in a variety of demographic and socioeconomic subjects with variants of the disease under study.

Phase 4 Trials:

n phase 4, the aim is to further characterize the safety of the drug through the identification of unknown adverse reactions and to potentially research new therapeutic indications. Companies often use this phase to gain exposure to different physicians and clinics, which aids in the marketing of their product.

Most of the drug manufacturing companies are using web based system for capturing; managing and reporting clinical data. This not only helps them in faster and more efficient data capture, but also speeds up the process of drug development. Medidata Rave is an example for web based data capture system. In Such systems studies can be set up for each drug trial. In built edit checks helps in removing erroneous data. The system can also be connected to other external systems. For example RAVE can be connected to IVRS facility to capture data through direct telephonic interviews of patients.

For more information on Clinical data management in Bangalore you can visit http://www.czinfosolutions.com

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