New technology and innovations to data management/biometrics process are transforming and expediting how clinical trials are conducted and the ways in which the resulting information is used for regulatory submissions. Online validation of data from the start results in efficiencies down the line when it becomes time to analyse and review study results. Real-time data provide information for making critical decisions in the management of clinical trials. CCDRD biostatisticians and data managers are integrated with the project teams to ensure development of investigator-friendly strategies to collect the information that will address critical questions in clinical trials. CCDRD AG works with industry leading applications down the line of data handling. Oracle Clinical™ ins its latest version 4.51 is used integrated with Oracle Thesaurus Managment System™ 4.5.2 for double data entry, data verification, data clarification and coding against any terminology desired (e.g. MedDRA, WHO-ATC, WHO-DRL).
Data is analyzed with the SAS Instititutes statistical packages.
Optionally RDC (remote data capture) directly into Oracle Clinical™ can be accomplished through online PDF data entry. |
