Improving Diversity in Clinical Trials: Strategies for Inclusive and Ethical Research
Clinical research aims to produce knowledge in the service of treating diseases and improving human health. In a just and
sponsors
Beginner’s Guide to IRB Review of IVD Research
IVDs diagnose and monitor health using biospecimens, often in labs. FDA-regulated but varied in compliance, IVDs require careful IRB review preparation.
Risk Assessment for use of Engineered Genetic Materials in Clinical Research
The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular
How Single IRB Review Mandates Help Research Sponsors
The Food and Drug Administration’s (FDA’s) proposed single institutional review board (sIRB) mandates are in part designed to support greater
FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy
The Food and Drug Administration (FDA) recently released new guidance regarding cellular and gene therapy products, one of which may
What is a Quality IRB Review?
Metrics in general are one of the ways we can gauge how well a program or service delivers. In the
Privacy Regulations Impact on Global Clinical Trial Endpoint Adjudication
New privacy regulations seem to form every few months, especially with individual U.S. states adopting their own privacy regulations (e.g.,
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.
Why Keep HIPAA Separate from the Informed Consent Form
The research informed consent form (ICF) is designed to provide prospective participants with the necessary information to make an informed
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.
Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials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