Regulatory Trends in Cell and Gene Therapies
As cell and gene therapy advances, the FDA is shaping regulatory trends to streamline approvals, support innovative therapies, and enhance global harmonization.
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Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials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
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
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
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, 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.
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