In this techno-savvy world, it is mandatory for companies to submit the clinical data electronically to regulatory authorities for approval and to take a green signal to market a product all over the world.Clinical data management system is playing a vital role in clinical research to produce a high quality data. Many software tools are available in the market (known as clinical data management system) to produce a reliable, consistent, accurate and statistically sound clinical data. Commonly used commercialized CDM tools are ORACLE CLINICAL, CLINTRIAL, MACRO, RAVE, ORACLE InForm and e-Clinical Suit. Some other tools like OpenClinica, open CDMS, Trial DB and PhOSCo are freely available in the market and are as good as their commercial counterparts in terms of functionality.
All these Electronic Data Capture solutions are widely adopted by clinical research organizations and life sciences organizations broadly classified as pharmaceutical, medical devices and biotechnology industries in all aspects of clinical research. Software vendors have successfully developed the technology of entering clinical data directly into the EDC software. EDC is preferred over a traditional paper based data collection methodology to streamline data collection and accelerate the time to market for drugs and medical devices. This software must be compliant with regulatory norms, robust, dynamic and user-friendly. 21 CFR Part 11 regulation was a mandate that any EDC software must comply with, which commonly defines the criteria under which electronic records and signatures are considered to be trust worthy, reliable and equivalent to paper records.To maintain a competitive position, the biopharmaceutical industry has been facing the challenge of increasing productivity both internally and externally.
Day to day implementation of these EDC solutions as well as with the introduction of customized software’s for Clinical Data Management, a number of global pharma companies have started outsourcing this to CRO’s and more recently to IT companies based in India, which has fastened the rate of recruitment of CDM professional’s. As Indian companies are able to offer a large scale data management services at very optimal costs, the next tier of companies is now increasingly looking to outsource and explore possibilities, which will boost the flow of work of CDM in India with a capital cost of many millions. For filling the gap of demand and supply many Institutes are now providing Short-term Clinical Data management Courses or programs with hands on practical exposures on live EDC software or tools to boost up the technical skills of a candidate and make them job ready for these Organizations.