Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance
When it comes to clinical development, precision, compliance, and quality assurance are paramount. Like any complex and highly regulated industry, […]
Reporting Requirements
What is a Data Monitoring Committee?
DMCs play a vital role in clinical trials by independently reviewing interim data for safety and effectiveness, ensuring participant protection throughout the study.
What is an sIRB and Why Does my Study Need One?
Single IRB (sIRB) review streamlines oversight for multisite trials, reducing administrative burdens while ensuring participant protections across all sites.
Device Risk Determinations for IVD Research
Clinical trials involving investigational in vitro diagnostic (IVD) devices are subject to the Food and Drug Administration’s (FDA’s) investigational device
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.
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
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.
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.
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
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
Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents
Efficient document systems like eTMF and eISF enhance compliance and streamline document management, helping sites and sponsors ensure secure, organized trial records.
4 Questions to Ask When Establishing a Pharmacovigilance Organization
Establishing a compliant pharmacovigilance (PV) function from scratch is often an overwhelming exercise for emerging biotech organizations, typically competing with