Evolving Trial Master Files Require Experienced TMF Resourcing
This blog post highlights the challenges inexperienced individuals face in maintaining a high-quality, complete, and...Continue reading→
Shifting the Approach: 4 Strategies for ICH E6(R3) Implementation
Successfully navigating the evolution of Good Clinical Practice requires well-defined implementation Strategies for ICH E6(R3)....Continue reading→
Gap Analysis and Collaboration Lead to Success
Gap analysis, when properly executed and coupled with true collaboration, is a foundational step for...Continue reading→
The Critical Role of the Medical Monitor In A Clinical Study
While the primary role of a medical monitor in a clinical study is fundamentally to...Continue reading→
How Biostatistics Can Help Your Business
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Maecenas facilisis faucibus sollicitudin. Mauris id semper...Continue reading→
How Sponsors and Patients Benefit from a Site-Centric Partnership
Creating a site-centric partnership between a pharmaceutical/biopharmaceutical sponsor and a clinical trial site is a...Continue reading→
Leveraging clinical trial data in real-time to effect change and mitigate risk
Properly applied, data analytics can improve clinical trial data quality, as well as potentially reduce...Continue reading→
Site-Relationship Strategy: Ensuring Quality Data and Study Performance
Strong relationships between a sponsor’s CRO and its clinical sites are instrumental to study success...Continue reading→