Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials
In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). It was the first drug to treat children with […]
Research Operations
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
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
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, Clinical, and Quality Considerations for Device Research
In response to a growing demand for faster, approved, and cost-effective medical devices for chronic diseases, medical device manufacturers and
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.
An Evolving Regulatory Environment for Rare and Orphan Diseases
Rare diseases affect fewer than 200,000 people each, totaling around 30 million in the U.S. Orphan drugs face R&D barriers, but FDA support has increased since 1983.