Five Essential Considerations for Efficient Site Contracts and Payments

Posted on Aug 1st, 2017

Author: Russell John Global Director of Grants Management Clintrax…

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

Posted on Jul 28th, 2017

The purpose of this glossary is to provide clarification of the most commonly used terms related to gene therapy and immunotherapy. The terms in…

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

Posted on Jun 12th, 2017

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

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Choosing the Right Solution: Improving the Site Feasibility Process

Posted on May 31st, 2017

Author: Jeff Barrett, MS Product SME, Site Feasibility Application ePharmaSolutions, a WIRB-Copernicus Group…

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

Posted on May 24th, 2017

Authors: Sharad Adekar, MD, PhD Medical Vice Chair Western IRB, a WIRB-Copernicus Group Company Currien MacDonald, MD, CIP Medical Lead and…

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

Posted on May 17th, 2017

Author: Kristy Fusco, MLD Product Manager, Safety Letter…

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Gene Therapy and Genomic Editing: Understanding Basic Concepts

Posted on Apr 5th, 2017

Author: Daniel Kavanagh, PhD Senior Director of Gene Therapy Research WIRB-Copernicus…

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Addressing the Challenges of Human Tissues and Cell Products Regulation

Posted on Mar 22nd, 2017

Authors: Currien MacDonald, MD, CIP Medical Lead and IRB Chair Western IRB, a WIRB-Copernicus Group Company David Forster, JD, MA, CIP Chief…

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Subject Recruitment Materials: Understanding the Requirements for IRB Review

Posted on Mar 15th, 2017

Authors: Lindsay A. Abraham, JD, CIP Regulatory Lead, IRB Chairs Western IRB, a WIRB-Copernicus Group Company Glenn Veit, JD, CIP IRB…

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Looking Ahead in 2017: Insights from Our Experts

Posted on Feb 22nd, 2017

Within the WIRB-Copernicus Group (WCG) family of companies, our subject matter experts are always watching regulatory and practice trends. Their…

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

Posted on Jan 24th, 2017

Authors: Lindsay A. Abraham, JD, CIP Regulatory Lead, IRB Chairs Western IRB, a WIRB-Copernicus Group Company Jeffrey A. Cooper, MD,…

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

Posted on Dec 14th, 2016

Authors: Daniel Borasky, MPH, CIP Vice President of Quality Management Copernicus Group IRB, a WIRB-Copernicus Group Company David Forster…

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Infectious Disease Challenge Studies: Ethical Issues in Causing Disease for Medical Knowledge

Posted on Dec 2nd, 2016

Authors: Daniel Kavanagh, PhD Senior Director, Biosafety & Gene Therapy WIRB-Copernicus Group Currien MacDonald, MD, CIP Board Chair…

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Reducing Study Team and Site Burden through an Integrated eClinical Platform Solution

Posted on Nov 21st, 2016

Author: Lance Converse Chief Innovation Officer WIRB-Copernicus…

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Towards Total Quality Management in Human Research Protection Programs: IRB Administrative and Reviewer Activities

Posted on Sep 27th, 2016

Author: Andrew Olmsted, MBA Executive Vice President IRBNet, a WIRB-Copernicus Group…

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Informed Consent Progress Toward an Improved Process

Posted on Sep 7th, 2016

Author: David Borasky, MPH, CIP Vice President of Quality Management Copernicus Group IRB, A Division of the WIRB-Copernicus…

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Minimizing Impact of New NIH Recombinant DNA Advisory Committee Review Process on Early Phase Human Gene Therapy Studies

Posted on Jul 29th, 2016

Authors: David W. Emery, PhD Director, IBC Services WCG Biosafety, A Division of the WIRB-Copernicus Group Joan M. Robbins, PhD Senior Vice…

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Managing Conflicts of Interest: Why an Independent IRB Should be Part of an Institution’s Policy

Posted on Jun 30th, 2016

Author: Stuart Horowitz, PhD, MBA President, Institutions & Institutional Services WIRB-Copernicus…

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Innovation in Investigator Site Contracting

Posted on Jun 30th, 2016

Author: Steven Jones, JD General Counsel & Corporate Secretary Clintrax Global, A WIRB-Copernicus Group…

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Glossary of Commonly Used Terms in Human Subject Protection

Posted on Jun 30th, 2016

This Glossary of Commonly Used Terms in Human Subject Protection was compiled from various federal and international sources to bring together all of…

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Under the Microscope: Biomarker and Diagnostic Tests as FDA-Regulated Devices

Posted on Apr 27th, 2016

Authors: David Forster, JD, MA, CIP Chief Compliance Officer, WIRB-Copernicus Group Currien MacDonald, MD, CIP Medical Lead & IRB…

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Alphabetical Glossary of Terms: Gene Therapy & Immunotherapy for Cancer

Posted on Apr 22nd, 2016

The purpose of this glossary is to provide clarification of the most commonly used terms related to cancer research and treatment using gene…

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Institutional IRB Performance: 2015 Optimizing and Benchmarking Report

Posted on Dec 23rd, 2015

Authors: Stuart Horowitz, PhD, MBA President, Institutions & Institutional Services WIRB-Copernicus Group Andrew M. Olmsted, MBA Executive…

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Clinical Trials and Social Media: Friends or Foes?

Posted on Nov 4th, 2015

Author: Lindsay McNair, MD, MPH, MSBioethics Chief Medical Officer WIRB-Copernicus…

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Best Practices: The Necessary Integration of Independent Review Boards and Institutional Biosafety Committee Review

Posted on Oct 15th, 2015

Authors: Christopher Jenkins, PhD, MPH, RBP, CHMM, Senior Vice President of Biosafety and Gene Therapy, WCG Biosafety, a Division of…

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Exploring the Importance of Rater Reliability in Drug Development for Alzheimer’s Disease

Posted on Sep 21st, 2015

Authors: Theresa Bromley, PhD Director, Global Rater Reliability Services at ePharmaSolutions, a WIRB-Copernicus Group Company Nicolas Troyano,…

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Proposed Changes to the Common Rule Governing Human Subject Research Protections

Posted on Sep 8th, 2015

Authors: David Forster, JD, MA, CIP Chief Compliance Officer, WIRB-Copernicus Group David Borasky, MPH, CIP Vice President, Quality Management…

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Changes to the Common Rule Governing Human Subject Research Protections are Imminent

Posted on Aug 27th, 2015

Authors: David Forster, JD, MA, CIP Chief Compliance Officer, WIRB-Copernicus Group David Borasky, MPH, CIP Vice President, Quality Management…

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Ethical Considerations for Oncology Clinical Research

Posted on May 29th, 2015

Author: Lindsay McNair, MD, MPH, MSBioethics Chief Medical Officer WIRB-Copernicus…

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Clinical Research in Parkinson’s Disease: The Advances, Challenges, and Importance of Rater Training

Posted on Apr 28th, 2015

Author: Marian A. Ormont, MD ePharmaSolutions, A WIRB-Copernicus Group Company To read this article in its entirety, please click…

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