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 datais a health and medical research resource collected during the course of clinicaltrial 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 managementinvolves the process of creatingplans for handling thedatacreated, managed, processed and stored by an organization. Clinical data managersare responsible for clearly, accurately and securely collecting,managing and reporting datain clinicaland pharmaceutical trials of different medical research projects. Theyworkcollaboratively with research team in an organization to handle performance issues or system resources; provide service maintenance and support internet sites.The job tasks of datamanagersare similar to database administrators to work with software, database systems and internet applications. Data managementprofessionals develop the design and implementdatacollection databases.
Clinical data managementincludes acquiring, validating, processing, protecting and storing datato 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 enteredand embedded in the database. Data reconciliationis the process that validates, clarifies and corrects reporteddata. Data managementcarefully monitors the clinical data to identify any discrepancies and missingdata. Successfuldata management requires precise and thorough planningapproach byData Management Plan(DMP) of anyproject.
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 enrolment 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. Managementand security of data is important and relevantduring clinical research. Properdata managementhelps ensure that vitaldatais protected, managed and stored within the organization.Datasecurity is essential indata managementto 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.
Online Course at JLI
James Lind Institute (JLI) provides an online program in Post Graduate Diploma in Clinical Research and Advanced PG Diploma in Clinical Research & Data management to train professionals how to manage clinical trial data.
For more information please visit: www.jli.edu.in