Clinical Data Management in India

India offers all requirements necessary for clinical data management activity such as patient, experts (data scientists), technology and government support to create new companies and better job opportunities.

Clinical Data Management

Clinical data is a health and medical research resource collected during the course of clinical trial program or ongoing patient care. Clinical data management leads to generation of high-quality and statistically reliable data from clinical trials. Data management is critical in clinical research to ensure collection and integration of appropriate quality of available data at an affordable cost. Strategy for data management involves the process of creating plans for handling the data created, managed, processed and stored by an organization. Clinical data managers are responsible for clearly, accurately and securely collecting,managing and reporting data in clinical and pharmaceutical trials of different medical research projects. They work collaboratively with research team in an organization to handle performance issues or system resources; provide service maintenance and support internet sites.The job tasks of data managers are similar to database administrators to work with software, database systems and internet applications. Data management professionals develop the design and implement data collection databases.

Clinical data management includes acquiring, validating, processing, protecting and storing data to ensure timely accessibility and reliability for users at administrative level. Clinical data management include various procedures of designing database for Case Report Form (CRF); CRF annotation; data entry, extraction and validation; discrepancy management; medical coding and database locking that are assessed at regular intervals for quality during a trial. Validation involves testing of data in accordance with the protocol specifications to identify the discrepancies through written edit check programs for data entered and embedded in the database. Data reconciliations the process that validates, clarifies and corrects reported data. Data management carefully monitors the clinical data to identify any discrepancies and missing data. Successful data management requires precise and thorough planning approach by Data Management Plan(DMP) of any project.

India – A major outsourcing hub for clinical trial services

India has acquired second most preferred destination for outsourcing clinical research services due to the advantages associated with faster enrollment of large pool of subjects; huge number of clinical experts; low cost and consolidated management databases. The ultimate goal of clinical data management to protect public health and propagate confidence in marketed devices or therapeutics is obtained through data support and assurance of conclusions derived from research studies. Management and security of data is important and relevant during clinical research. Proper data management helps ensure that vital data is protected, managed and stored within the organization. Data security is essential management to protect from loss and thefts of data.

The biggest challenge of standardizing the process of clinical data management from regulatory perspective in an organization lies in development of regulatory procedures and data standards.By meeting the increasing demand to improve the regulatory requirements and standards of clinical data management can ensure faster commercialization and beat competition. The clinical professionals with implementation of regulatory compliant data management tools can meet appropriate expectations, set standards for data quality and adapt to the rapidly changing technology by gradual shift to electronic systems. Technological developments can positively impact the clinical data management process and systems encouraging better results in quality of data.