Using Public and Private Data for Clinical Operations
Comparing mean vs. median to uncover the full data picture of site-level performance.
Biomedical R&D Faces New Regulatory Policies and Priorities
With a new administration in Washington, sponsors and regulators are weighing several initiatives that promise to reshape clinical research policies.
ICH Approves GCP Guideline Amendment
The Council adopts revision encouraging sponsors to implement improved oversight and management of clinical trials.
How Important is Big Data?
Survey collects thoughts from industry professionals on the current and future impact of big data in clinical trials.
Europe’s Drug Regulators Eye a Post-Brexit Prize
With bidding starting to intensify among member states, several factors will determine the EMA’s next home.
FDA Binding Guidance: A Pivotal Milestone for CDISC Standards
For those still waiting, the time is now to get compliant on FDA's new data submission requirement.
IRB-Investigative Site Relationship Makeover
New study finds that the long-strained relationship between sites and institutional review boards may finally be improving.
New Benchmarks for Trial Initiation Activities
Assessing practices and inefficiencies with site selection, study start-up, and site activation.
Exploring the Role of the Regional Coordinator
How one large academic trial adopted a coordinating center model-helping drive early-model RBM gains
The Role of Big Data in Clinical Trials
Q&A looks at the growing use of unstructured data in drug development and the evolving role of the clinical data manager amid the advent of real-world data as a research aid.
Updated CDISC Glossary
In its first published update since 2011, the CDISC Glossary Project Team has updated this resource, which includes hundreds of definitions for key terminology related to clinical research.
Applied Clinical Trials, December 2016/January 2017 Issue (PDF)
Click the title above to open the Applied Clinical Trials December 2016/January 2017 issue in an interactive PDF format.
Considerations on the Impact of Direct-to-Patient Contacts
Examining interventional vs. non-interventional clinical study classification in the EU.