One of the challenge pharmaceutical and biotech companies faced today within their Clinical Data Management is the rapid changes and improvements in data management/capture technology.
Electronic Data Capture tools such as Oracle InForm and Medidata Rave allow for obtaining large sample sizes with reduced unit costs through global access, fast interaction, and automation. They provide a fast and easy avenue for the acquisition of scientific data, and this method of data acquisition will become much more common place in future multi-center clinical trials.
The implementation of EDC system eliminates the need for double-key data entry as the system automatically checks for inconsistent, illogical or missing data. In EDC, most of the data management planning and implementation are completed even before data entry is initiated. The annotated CRF, database design, and the vast majority of edit and logic checks are finalized prior to enrolling the first subject. The CDM can now look at the data in real-time, and begin the generation of data listings and identification of potential problems early during the course of a study. Training for CDMs in this new global environment, must accommodate this change in technology and shift in the clinical data management paradigm.
THE GOALS OF GLOBAL CLINICAL DATA MANAGEMENT
RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.
The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union. For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.