Business Case to Resolve

• Data Quality Monitoring: "Our clinical trials have been outsourced to many CROs. Some CROs do a great job, and some don't. Our CDM group needs a tool to monitor/QC the data collected from CROs. (By the tool,) our CDM staff can define and execute post hoc validations on receiving data to find issues in its early stage. We are short of CDM staff, and most don't have SAS® or SQL knowledge, a tool that is easy to use is vital."

• Comprehensive Data Review and Patient Profiling: "The team needs to review and research clinical trials data. Such review could be a quick data listing, an AE summary by age group, a change-from-baseline chart, or patient profile research. Since it is ad-hoc and ongoing, it would be a big deal to us if such a tool exists."

• Clinical Data Warehousing/Consolidator: "Our studies are from hybrid sources, mostly non-CDISC. We are looking for a tool that can funnel data from different studies and provide a centralized view. For example, medical doctors can search an adverse event across all protocols. The team can use the same tool to run summary statistics, data listings, and graphs without requiring SAS(r) programming."

• Clinical Trials Documentation Central: "We would like to a document control tool for our clinical trials projects. The tool must have high degree of access control with full audit trails and documentation lifecycle control. Each document depending on its lifecycle stage, we can control who can create, review, modify, approve, comment, or read/download."