news roundup

FDA Initiatives Advance Orphan Therapies

Agency programs aim to increase biomarkers and early advice to sponsors for more efficient and cost-effective clinical trials for rare disease.

Europe Mulls Rival Approaches to Tackling Disease

Policy discussions include focus on targeted treatments on one side and wider access and prevention-over-treatment on the other.

Quanticate Sponsors PhD Research into Response-Adaptive Trial Design

Quanticate has announced that it is partnering with Lancaster University to sponsor a STOR-i PhD project. The partnership will support research into optimizing clinical trial design for rare disease and the role of response-adaptive randomization.

Survey Reveals CROs Industrywide Shift to Modernize Clinical Trial Processes

91% of CROs are driving industrywide momentum to unify clinical systems and streamline trial processes for better visibility and improved study execution, according to a new global industry survey from Veeva Systems which gathers the experiences and opinions of CRO respondents from around the world.

Articles

The Basics of Clinical Trial Centralized Monitoring

Examining the practicality of implementing CM techniques to drive trial oversight efficiency while saving on-site monitoring resources and costs.

Blockchain in Research, from Business to Personal

Blockchain is moving toward definitive uses in clinical trials to enhance clinical supply capabilities, with the potential of enabling data ownership for patients.

RBM

Risk-Based Monitoring Versus Source Data Verification

Pilot study compares a risk-based monitoring and remote trial management method with traditional on-site source data verification for trial oversight.

Ask the editor

Lisa Henderson
Editor in Chief
Lisa.Henderson@ubm.com