Product Details

Clinical Trial Data Demands Spur Changes

As clinical research studies collect an ever more varied set of data elements – everything from biomarker and genetic data to real-world evidence amassed from social media or mobile applications – a rising number of data points come from incompatible data sources that cannot be easily integrated into traditional electronic data capture systems (EDC), which has contributed to longer database lock times and data management challenges.

Volunteers Expect Information About Trial Results, but Sponsors and Sites Struggle with the Best Way to Share it

Clinical trial study volunteers increasingly expect to receive information about trial results, but sponsors and sites struggle with the best way to deliver the information.

Also in this issue:

• Addressing Patient Diversity by Adding a “Human Touch” to Trial Conduct
• How Risk-Based Monitoring is Driving Regulatory Compliance
• Regulatory Update
• Month in Review
• FDA Actions
• Study Lead Opportunities
• New Drugs in the Pipeline