Data management redefined

• Main Author: Nimita Limaye
• Format: Article
• Language: English
• Published: Wolters Kluwer Medknow Publications 2010-01-01
• Series: Perspectives in Clinical Research
• Subjects: CDM; EDC; eclinical; Personalized medicine; Adaptive trials; Clinical event Adjudication; Pharmacogenomics; Biochips; Semantic interoperability; HIPAA; GINA; Data standards
• Online Access: http://www.picronline.org/article.asp?issn=2229-3485;year=2010;volume=1;issue=3;spage=110;epage=112;aulast=Limaye

Core perspectives on the traditional approach to CDM are rapidly changing and EDC and new eclincal initiatives are redefining the face of data management. Associated with EDC are not only the higher efficiencies, resulting in lower study costs, but its applications in key areas such as adaptive trials and clinical event adjudication; however the cost and effort involved in deployment and integration remain a deterrent. The role of the data manager may change to that of a data broker who manages the exchange of data from multiple sources, and semantic interoperability, data standards and data privacy will prove to be the defining factors. Simulation modeling, pharmacogenomics, personalized medicine and EHRs will no longer exist as silos and seamless data flows will be the drivers of healthcare solutions.