In present state of affairs, clinical research is considered as one of the promising domains for any health care organization. Clinical research studies leads to the generation of data whose management is not an easy task to perform by any biopharmaceutical organization. Clinical Data Management System (CDM) is leading clinical development industry into a new innings of transformation. It also now faces an elevating attention from the safety and regulatory sectors, which have never been seen earlier.
In the clinical trial arena, Clinical Data Management System is defined as “the development, execution and supervision of plans, policies, programs and practices that control, protect, deliver and enhance the value of data and information assets”. Review and authentication of new drugs by drug regulatory agencies is completely relying on a faith that the data which is submitted is of appropriate validity which safeguard the self-assurance in result and conclusions laid down by pharma industries. Clinical Data Management System is a very important urge for the biopharmaceutical organization, so the person involve in CDM must have scientific approach and qualification. The educational requirement for these personnels should be graduates or doctorate in life science and having good knowledge of computer applications. Additionally, the important key roles played by the CDM teams are: Data Manager, Database Programmer/Designer, Clinical Data Coordinator, Quality Control Associate, Data Entry Associate, and Medical Coder.
Data management and data quality are important critical assets of every pharmaceutical organization or CRO that perform human clinical trials. Data should be of the uppermost expected quality to meet both the requirements of accuracy in human trials and historically strict government regulatory conditions. Clinical data interchange standards consortium, is an interdisciplinary organization, which has created standards to maintain acquisition, exchange, submission, and factuality of clinical research data.
In the course of study, the Clinical Data Management System or quality assurance team should continually assess and verify the data collection and database for completeness and consistency. The measurement of performance and productivity is pivotal to drive the successful achievement of project goals. Additionally, there seems to be a common need to develop and adopt a list of primary performance indicators so as to scrutinize the clinical data regardless whether they are PDC- or EDC-based. A sponsor may end up considering a form complete only when all required data entry has been completed, when there are no open queries, and the form has been source-verified.
Electronic data capture (EDC) technology approval in the market has raised new opportunities for improvement, configurability, and intelligency. The demand to progress clinical adaptability continues to develop, and motivate industry sponsor to look forward for an e-clinical atmosphere. It provides and support formative eCRF trial design, construct, and rapid distribution, robust data management, real-time visibility, covering and analysis, and worldwide trial management and study expandability.
Clinical Data Management is thus not only involves in data entry processes but also involve in many other corporate clinical work. It provides complete and accurate data in appropriate format & time. It also assures clear data and ‘ready to lock’ databases. In today’s growing demand of data management, Clinical Data Management professionals must meet suitable expectations and put accurate principles for data quality and security. They should also have a focus on becoming accustomed to the rapidly changing & growing technology for the betterment and successful data management for the biopharmaceutical organization.