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 Data Standards in Clinical Trials: A Paradigm Shift


 

Data Standards in Clinical Trials: A Paradigm Shift

 

Data storage management has always been a chief concern in all the researches and trials as they get into process. Efficient management and strategic planning of recording data is the major area which CTM (Clinical Trial Management) team focuses the most.

 

Time and again Data standards are defined and categorized by the industry and global authorities. Whereby, the quick and steady adoption to these pertaining and ever-changing Compliances remains the prime motive in the entire clinical and pharmaceutical industry. The standards are set and modified repeatedly to ensure that evolving and innovative technology in the Clinical Research field stands in lines with the lines set by Regulatory Authorities.


WHY DATA STANDARDS?

 

Data standards are set of protocols that make the collection of records across all the clinical industry generalizable and easy to comprehend by any clinical professional without any assistance. Roughly these standards are a common global language to create a communication efficient in terms of exchange of data, evaluation, treatment of patient history across the clinical and health care industry. The clinical reports made on par with the data standards helps for comparison and future reference for any other research in same field and areas.


Date back standards were set by independent organization in their own pattern. But somehow later it was felt that the different standards by different organization worldwide created a huge gap. The clinical literature review behind the parent country of research material faced problems to analyze and evaluate the data recorded.


These bottlenecks and gaps highly in terms of exchanging Data affects drug development in terms of cost and time involved. To avoid these significant barriers, organization such as Clinical Data Interchange Standards Consortium (CDISC) and Society for Clinical Data Management (SCDM) came into existence with a mission to give interoperability of medical and clinical research beyond the borders. These organizations maintained the certain set of principles for every mode employed for the data recording. It was stressed that manual handling created loopholes and immense blunders so a mechanized way was proposed and thus came protocols to be followed for stringent authentication and validation support.

 


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