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Insights

…But Is It Gene Therapy? Debating a (Controversial) Definition

Author:

Daniel Kavanagh, PhD
Senior Director, Biosafety and Gene Therapy
WIRB Copernicus Group

By |September 20th, 2017|Insights, White Papers|

Pragmatic Clinical Trials: What You Need to Know

Author:

Jeffrey A. Cooper, MD, MMM
Vice President, Process and Strategic Improvement
WIRB Copernicus IRB Group

By |September 13th, 2017|Insights, White Papers|

Clinical Trial Recruitment Practices: The Evolution of Ethical Considerations

Authors:

Lindsay McNair, MD, MPH, MSB
Chief Medical Officer
WIRB-Copernicus Group 
 
David Borasky, MPH, CIP
Vice President, IRB Compliance
WIRB-Copernicus Group

By |August 23rd, 2017|Insights, White Papers|

Five Essential Considerations for Efficient Site Contracts and Payments

Author:

Russell John
Global Director of Grants Management
Clintrax Global

By |August 1st, 2017|Insights, White Papers|

Alphabetical Glossary of Terms: Gene Therapy & Immunotherapy, 2nd Edition

The purpose of this glossary is to provide clarification of the most commonly used terms related to gene therapy and immunotherapy. The terms in this glossary are listed alphabetically, with illustrations where appropriate.

Author:

Daniel Kavanagh, PhD
Senior Director, Biosafety and Gene Therapy
WCG Biosafety

By |July 28th, 2017|Insights, White Papers|

The Revised NIH Guidelines 2016: Assessing the Impact on Human Gene Transfer Clinical Trials

Author:

David W. Emery, PhD
Director, IBC Services
WCG Biosafety, A Division of the WIRB-Copernicus Group

By |June 12th, 2017|Insights, White Papers|

Choosing the Right Solution: Improving the Site Feasibility Process

Author:

Jeff Barrett, MS
Product SME, Site Feasibility Application
ePharmaSolutions, a WIRB-Copernicus Group Company

Investigational Drugs Outside of Clinical Trials: Understanding Expanded Access and Right-to-Try

Authors:

Sharad Adekar, MD, PhD
Medical Vice Chair
Western IRB, a WIRB-Copernicus Group Company

Currien MacDonald, MD, CIP
Medical Lead and IRB Chair
Western IRB, a WIRB-Copernicus Group Company

Lindsay McNair, MD, MPH, MSB
Chief Medical Officer
WIRB-Copernicus Group

R. Bert Wilkins, JD, MHA, CIP
IRB Chair
Western IRB, a WIRB-Copernicus Group Company

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

Author:

Kristy Fusco, MLD
Product Manager, Safety Letter Distribution
ePharmaSolutions

Gene Therapy and Genomic Editing: Understanding Basic Concepts

Author:

Daniel Kavanagh, PhD
Senior Director of Gene Therapy Research
WIRB-Copernicus Group

By |April 5th, 2017|Insights, White Papers|