Beginner’s Guide to Single IRB Mandates
As clinical trial efficiencies grow, understanding single IRB mandates becomes crucial for sites and sponsors navigating ethical review processes.
Site/Sponsor Relationships
FDA’s September 2022 NPRMs: What They Mean for Academia and Industry
On September 28, 2022, the Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRM). These notices proposed
Modernizing Site Feasibility and Selection
Study startup is a complicated, multi-faceted process – notoriously prone to delays due to the many stakeholders, systems, and decisions
Strategies for Successful Site Selection in Clinical Trials
Clinical trial site selection can make or break a trial’s success before it even begins. The average cost to open
Keys to Unblocking the Innovation Bottleneck in Research
Is the clinical research industry winning or failing at innovation? It probably depends on who you ask and likely full
Streamline Study Startup with Improved Site Selection & Feasibility
Site selection for clinical trials is often one of the biggest headaches for pharmaceutical sponsors and contract research organizations (CROs).
Regulatory and Ethical Considerations for eConsent in Research
IRB oversight, identity verification, and comprehension checks are critical in eConsent, ensuring ethical and legal standards while improving participant understanding.
Enhancing Research Conduct Using eConsent
eConsent in clinical trials enhances participant understanding and flexibility but requires careful planning, regulatory compliance, and IRB coordination to ensure success.
5 Questions to Ask Your Sponsor for DCT Implementation
The pandemic proved decentralized clinical trials (DCTs) can reduce patient burden while delivering quality data in a streamlined environment. In
Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents
Efficient document systems like eTMF and eISF enhance compliance and streamline document management, helping sites and sponsors ensure secure, organized trial records.
A Checklist for Optimizing Clinical Trial Study Startup Activities
From protocol design to site training, optimizing study startup requires meticulous planning and collaboration to ensure timely trial activation.