Clinical Trials

 

…But Is It Gene Therapy?: Debating a (Controversial) Definition
by WIRB-Copernicus Group

Minimizing Impact of New NIH Recombinant DNA Advisory Committee Review Process on Early Phase Human Gene Therapy Studies
by WIRB-Copernicus Group

The Revised NIH Guidelines 2016: Assessing the Impact on Human Gene Transfer Clinical Trials
by WIRB-Copernicus Group

Pragmatic Clinical Trials: What You Need to Know
by WIRB-Copernicus Group

Managing the Unmanageable: Meeting the Challenge of Appropriate Safety Report Distribution
by ePharmaSolutions

Interventional Clinical Trial or Registry Study?: Writing Protocols that Demonstrate the Difference
by WIRB-Copernicus Group

Innovation in Investigator Site Contracting
by Clintrax Global

Gene Therapy and Genomic Editing: Understanding Basic Concepts
by WIRB-Copernicus Group

Investigational Drugs Outside of Clinical Trials: Understanding Expanded Access and Right-to-Try
by WIRB-Copernicus Group

Choosing the Right Solution: Improving the Site Feasibility Process
by WIRB-Copernicus Group

Alphabetical Glossary of Terms - Gene Therapy & Immunotherapy - Revised, Second Edition
by WIRB-Copernicus Group

Document Control in GxP Environments
by Solabs

Strategies for Rapid EQMS Deployment
by Pilgrim Quality Solutions

A New Approach to Quality and Compliance eLearning
by UL EduNeering

Tale of Two C's: From Compliance to Competency
by UL EduNeering

Measuring Training Effectiveness: A Benchmarking Study – 2014 Results; 2015 Forecast
by UL EduNeering

The FDA's Focus on Metrics, Performance and Quality
by UL EduNeering

Life Science 2014 Benchmarking Study: Trends and Best Practices Based on Our Work with the US FDA and Over 250 Companies
by UL EduNeering

Cutting Costs, Saving Time: Improving Life Sciences Operations with Digital Signatures
by ARX

DOJ's Laser Focus on GMPs in 2013
by UL EduNeering

FTC v. Actavis: After the Verdict
by Datamonitor

The Pharmaceutical Industry's Transition to Electronic Processes
by MasterControl

ComplianceWire: Life Science 2012/2013 Benchmarking Study
by UL EduNeering

The Saas LMS and Total Cost of Ownership in FDA-regulated Companies
by UL EduNeering

How to Report Suspected False Data to the FDA
by FDAnews