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Insights

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|

Addressing the Challenges of Human Tissues and Cell Products Regulation

Authors:

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

David Forster, JD, MA, CIP
Chief Compliance Officer
WIRB-Copernicus Group

By |March 22nd, 2017|Insights, White Papers|

Subject Recruitment Materials: Understanding the Requirements for IRB Review

Authors:

Lindsay A. Abraham, JD, CIP
Regulatory Lead, IRB Chairs
Western IRB, a WIRB-Copernicus Group Company

Glenn Veit, JD, CIP
IRB Advisor & Executive IRB Chair
WIRB-Copernicus Group

By |March 15th, 2017|Insights, White Papers|

Looking Ahead in 2017: Insights from Our Experts

Within the WIRB-Copernicus Group (WCG) family of companies, our subject matter experts are always watching regulatory and practice trends. Their observations, combined with a deep understanding of the science and practice of clinical research, provide the basis for our strategic planning. In this way, we support both our biopharma partners and our institutional partners to be prepared for not only what’s happening […]

By |February 22nd, 2017|Insights, White Papers|

Interventional Clinical Trial or Registry Study? Writing Protocols that Demonstrate the Difference

Authors:

Lindsay A. Abraham, JD, CIP
Regulatory Lead, IRB Chairs
Western IRB, a WIRB-Copernicus Group Company

Jeffrey A. Cooper, MD, MMM
Vice President, Process & Strategic Improvement
WIRB-Copernicus Group

By |January 24th, 2017|Insights, White Papers|

The 21st Century Cures Act: Implications for Human Subject Protections

Authors:

Daniel Borasky, MPH, CIP
Vice President of Quality Management
Copernicus Group IRB, a WIRB-Copernicus Group Company

David Forster JD, MA, CIP
Chief Compliance Officer
WIRB-Copernicus Group

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

By |December 14th, 2016|Insights, White Papers|