Publications
Ensuring Proper Training for Clinical Research Staff in Less Time
Proper training assures sponsor organizations that their research meets all of the industry’s standards of compliance, and that their clinical studies will be conducted in a well-controlled, high quality manner that will withstand the rigors of regulatory inspection.
Risk Management in Clinical Research: Process and Application
The applicable guidances for good clinical practice (GCP), ICH E6 and ISO14155, state explicitly that the sponsor is responsible for quality assurance and quality control. One aspect of quality involves how risks are approached and managed throughout the course of a clinical trial, and is the focus of this article.
Medical Device Clinical Trials – How Do They Compare with Drug Trials?
Although clinical trials for medical devices have many similarities to those for pharmaceuticals, there are some necessary differences in the way the trials are designed and carried out.
Building a Basic Good Clinical Practice Foundation to Weather the Storm
A primed market coupled with an increase in financial and regulatory burdens has created a perfect storm that has the potential to threaten innovation at a time when it is most needed. Preparation to weather this storm will require additional clinical data for device manufacturers, and an increase in scrutiny of how clinical trials are being conducted.
Daily Documentation Essentials:
A Tour of the Regulatory Binder
Proper documentation is a tangible trail that tells the story of the trial from conception to completion, reflecting adherence to applicable regulations and demonstrating trial integrity through transparency. This article will discuss the documents most essential in clinical research, and the regulatory basis for their maintenance.
510(k) Clinical Data Requirements
Current Status and Considerations for Clinical Studies In an effort to promote innovation while protecting the population at large, the U.S. Food and Drug Administration (FDA) has for several years been on a course to revise the existing regulatory pathway surrounding the 510(k) process for medical devices. One topic of concern focuses upon clinical data.
GxP Lifeline - Good Clinical Practice:
From Review to Application
As clinical research professionals, we often hear phrases like, "It's in the regs!" Or, "It's GCP!" At times, it may seem as though by classifying our actions as "GCP," we wave a magic wand that ensures regulatory compliance. But what is GCP, and what does it mean to be GCP compliant? In order to take "good" to "great," it is important understand the conceptual framework that supports good clinical practice and be able to apply that understanding in daily research practice.
