Solving Data Collection Challenges

Cross-partnership between sponsors and CROs for the collection and analysis of clinical trial data are complex. As a result there are a number of issues encountered during the running of  trial. As with many projects, standardization projects like CDISC is a huge undertake. It requires resources, technology and knowledge-transfer. The industry (FDA for example) hasContinue reading “Solving Data Collection Challenges”

CDISC/CDASH Standards at your Fingertips

A standard database structure using CDISC (Clinical Data Interchange Standards Consortium) and CDASH (Clinical Data Acquisition Standards Harmonization) standards can facilitate the collection, exchange, reporting, and submission of clinical data to the FDA and EMEA. CDISC and CDASH standards provide reusability and scalability to EDC (electronic data capture) trials. There are some defiance in implementingContinue reading “CDISC/CDASH Standards at your Fingertips”