Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. While drugs
IRB
Unique First-in-Human Phase I IRB Considerations you Might not Know About
Explore unique IRB considerations for first-in-human Phase I trials, from informed consent to participant protections and robust incentives.
Sickle Cell Disease: The Importance of Amplifying Patient Voices
Having a one in four chance of developing sickle cell disease (SCD) is uniquely, and overwhelmingly, familiar to the African
NIH 2023 Data Management and Sharing Policy: What you Need to Know
In an effort to accelerate the sharing of biomedical research results, the National Institutes of Health (NIH) issued its finalized
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
How to Optimize Your sIRB Experience
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Rare and Orphan Diseases in Regulated Development
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
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.,
Your Guide to sIRB Mandates
In the past few years, new regulations and policies have been announced and implemented to address the challenges of conducting clinical trials involving multiple research sites. Chief among these requirements is the use of a designated sIRB for multisite research.
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
Evaluating Payment to Participate in Research: Ethical and Regulatory Issues
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials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