'Audit-proofing' Your Trials
Increased adoption of decentralized trials and new advancements in technology among reasons for evolving regulatory landscape.
More than Just Rules: Raising the Bar in GCP Adherence
Stepped-up training and real-time application key to avoiding compliance pitfalls.
Proposed ICH-GCP E6(R3) Guidance: Principles in Action
How to support trial investigators through decentralization of trial elements.
FDA Focuses Efforts on DHT
Agency provides update on decentralized trials and digital health technologies at DIA 2023.
eSource Interoperability Between EHR and EDC
Evidence from a Phase III cancer trial points to notable advances in data-transfer tech.
The First eCOA Forum Examines BYOD and Item Skipping
eCOA and PRO consortiums along with regulators gather for discussion on important data collection topics.
Bridging the Immunity Gap: An In-Depth Conversation with GeoVax's CEO, David Dodd
In this Q&A, Dodd speaks about GeoVax's vaccine development strategy, clinical trials, and approach to serving patient populations often overlooked by conventional vaccines.
Pharma Trade Group Giants Update Principles on Clinical Data Sharing
A look at the complexities—and potentially conflicting goals—in industry’s commitment to trial-result transparency.
FDA Inspections Face Overhaul
The agency proposes significant revisions to oversight programs for drugs and medical products.
Clinical Trial Feasibility Observations
Changing the expectations of the feasibility study can improve the process.