Technological Advances
Decentralized Clinical trials have become increasingly prevalent in the biotech and biopharmaceutical industries.
Decentralized Clinical trials have become increasingly prevalent in the biotech and biopharmaceutical industries. Experts suggest the value of DCTs will increase by 9.8% between 2023 to 2029. Decentralized Clinical trials are cost effective and offer many benefits to researchers and participants alike, which is likely the cause of their increased usage. However, there are also some risks involved. To address this, the FDA released draft guidance to regulate DCTs and ensure participant privacy and data is protected. The guidance covers data collection and storage, investigator and sponsor responsibilities, and more.
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Decoding Your FDA Form 483 and Warning Letter: A Practical Guide to Remediation
This article explains how to interpret an FDA Form 483 and Warning Letter, identify underlying causes, and develop an effective remediation strategy. It emphasizes the importance of timely, well-documented corrective action and provides practical guidance for addressing inspectional observations.
How to Prepare for an FDA Inspection: A Step-by-Step Guide
An FDA inspection doesn't have to be daunting. Our step-by-step guide provides a roadmap for proactive preparation, covering everything from QMS review to effective FDA-483 responses. By taking a proactive approach, you can ensure your team is ready for a successful inspection outcome.
Practical Guide on How to Adapt Your Auditing Practices for the Implementation of ICH E6 (R3)
Download this poster to explore how evolving global guidance is shaping the future of auditing, including risk-based approaches, updated SOPs, and technology-driven practices.
Understanding Quality Oversight: Monitors vs. Auditors vs. FDA: A Quality Perspective
A practical breakdown of how monitors, auditors, and FDA inspectors each contribute to quality oversight, compliance, and inspection readiness across the trial lifecycle.
A Closer Look at Inspection Readiness: Mock/Hats On-Off Approach
A practical framework for strengthening compliance, inspection behaviors, and organizational preparedness for regulatory inspections
How to Secure Project Assignments with FDAQRC: A Guide for Consultants
At FDAQRC, project assignments are thoughtfully matched to consultant expertise, availability, and readiness, so understanding what influences those decisions can help you position yourself for more opportunities.
Tips For Preparing & Hosting a Successful Audit
Turn audit stress into strategic success with these expert preparation and hosting tips
Regulating AI in Clinical Trials: What ICH E6(R3) Does (and Doesn’t) Say
Despite AI’s growing role in clinical trials, ICH E6(R3) remains silent—does this leave room for innovation or uncertainty?