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
sites
Unpacking IRB Innovations for Decentralized Clinical Trials
In the blink of an eye, the world has gone digital. So many tasks which used to require going to
How Paper and Electronic Source Data Meet ALCOA-C Principles
According to the FDA, data should meet certain fundamental elements of quality (ALCOA), whether they’re recorded on paper or electronically.
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
How the IND 30-day Hold Impacts Clinical Trial Activities
The Food and Drug Administration (FDA) is the federal entity in the U.S. charged with (among other things) “ensur[ing] that
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).
Scale Your Training Program: 3 Successful Models
From live sessions to eLearning, scalable training models ensure clinical research teams stay effective, well-informed, and adaptable to new protocols.
Beginner’s Guide to 21 CFR Part 11 Compliance
Ensuring 21 CFR Part 11 compliance in research software protects data integrity, security, and audit trails, essential for meeting FDA electronic documentation standards.
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