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Press Release: WIRB‐Copernicus Group Thought Leaders Tapped for Key Roles at 2013 AAHRPP Conference
Princeton, NJ (April 3, 2013) – The WIRB‐Copernicus Group, the world’s largest provider of regulatory and ethical review services for human research, announced today that Jeffrey A. Cooper, MD, MMM, Vice President of Global Consulting for The WIRB‐Copernicus Group and Carrie Fisher, PhD, MBA, Vice President of Process Development…READ MORE
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CGIRB named a Training Magazine Top 125 finalist
For the second year in a row, CGIRB has been named a finalist in Training magazine’s annual Top 125, which ranks companies’ excellence in employer-sponsored training and development programs. The final rankings will be announced during Training’s 2012 Conference and Expo, scheduled for Feb. 18-20 in Orlando, Florida. Training…READ MORE
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Tim Schuckman serves as Scope Summit speaker
Tim Schuckman, Director of Business Development will be speaking with Jennifer Peterson, Senior Clinical Trials Manager – Duke Clinical Research Institute at the Scope Summit being held February 5-7 in Miami, Florida. Their presentation titled “Benefits of Establishing a Strategic Partnership between the ARO/CRO and the Central IRB” will…READ MORE
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Yvonne Higgins serves on PRIM&R planning committee and as faculty member
Yvonne Higgins, CGIRB’s Vice President, Quality Management, served on the planning committee to create this year’s annual PRIM&R event, Advancing Ethical Research Conference, slated for Dec. 3 through Dec. 6 in San Diego, Calif. In this role, Higgins worked with peers to plan 150 practical workshops and didactic sessions….READ MORE
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Jeffrey Cooper speaks at PRIM&R
Jeffrey A. Cooper, MD, MMM will be speaking at PRIM&R’s 2012 Advancing Ethical Research Conference Dec. 3 through Dec. 6 in San Diego, Calif. The annual Advancing Ethical Research Conference serves those involved in every facet of the research arena. The 2012 conference will bring together nearly 3,000 individuals…READ MORE
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Press Release: Copernicus Group IRB named Fast 50 Company
November 20, 2012, Research Triangle Park, N.C. – Copernicus Group IRB (CGIRB), a leading independent institutional review board, accepted Triangle Business Journal’s annual Fast 50 award, which recognizes North Carolina’s 50 fastest-growing private companies in the Raleigh-Durham area. Dawn Pope, CGIRB’s Chief Operating Officer, accepted the award at the…READ MORE
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Nick Slack featured in November Scrip Regulatory Affairs
Nick Slack, Vice President of Consulting at CGIRB’s sister company – Western IRB (WIRB), is featured in this month’s issue of Scrip Regulatory Affairs. Scrip Regulatory Affairs (SRA) is the leading provider of regulatory news, analysis & practical guidance for the pharma, biotech and medtech industries. Slack discusses the…READ MORE
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ASCO Annual Meeting
May 31, 2013
The ASCO Annual Meeting brings together more than 25,000 oncology professionals from a broad range of specialties. This year's meeting theme is "Building Bridges to Conquer Cancer." Email bd@cgirb... Read More
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CGIRB celebrates 17 years of providing IRB Review Services
July 1, 2013
Since being established in July 1996, CGIRB has achieved many milestones, including multiple clean routine FDA inspections (no 483s, ever), full AAHRPP Accreditation, ISO 9001:2008 certification, laun... Read More
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CGIRB Connexus Launch – 3rd Anniversary
September 30, 2013
CGIRB celebrates the 3rd anniversary of the launch of Connexus, CGIRB's award-winning e-document management web portal. CGIRB Connexus®is the most advanced integrated paperless document management... Read More
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PRIM&R 2013 Advancing Ethical Research Conference
November 7, 2013
Planning to attend PRIM&R this year? Contact CGIRB via email to bd@cgirb.com to connect with us in Boston during the conference! Learn more about the conference by clicking here to visit the... Read More
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Lean Six Sigma in the Clinical Trial Industry: Two Perspectives
by Dawn Pope As seen in Applied Clinical Trials Consistent, effective process improvement can be the key to reducing delays and improving data accuracy. In clinical trials, turnaround time and data accuracy are critical. The cost of a one-day delay in a drug being brought to market can…READ MORE
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Streamlining the IRB submission process through collaboration
By Dawn Pope, Chief Operating Officer Effective collaboration with your institutional review board can help prevent delays in start-up activities that can cost sponsors and CROs valuable time and negatively impact site enrollment activities. In this quarter’s newsletter, Copernicus Group IRB’s Director of Client Services, Dawn Pope, explores ways…READ MORE
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The role and use of Impartial Witnesses in the informed consent process
By Patience Stevens, MD, MPH, CIP Board Vice Chair Person Federal regulations for the protection of human subjects assign the principal investigator with the ultimate responsibility for ensuring the safety, rights and welfare of research subjects. Chief among those responsibilities is the obligation to ensure that the regulatory and…READ MORE
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Dealing with over-reporting: Understanding the FDA’s new regulations
By Glenn Veit, JD, CIP, Copernicus Group IRB Chairperson The Food and Drug Administration this year published revised regulations pertaining to safety reporting for drug and biologic products under an Investigational New Drug (IND) application. The FDA also made bioavailability (BA) and bioequivalence (BE) studies conducted to support the…READ MORE
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Advanced Notice of Proposed Rulemaking (ANPRM): Enhancing Protections for Research Subjects & Reducing Burden, Delay & Ambiguity for Researchers
by Yvonne Higgins, AB, CIP, Director, Quality Management Background On July 22, 2011, the U.S. Department of Health and Human Services (HHS) announced a proposal that may result in significant changes to federal regulations on the protection of human research subjects. In the notice, published in the federal register,…READ MORE
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Reducing the Reporting Burden: Guidelines for Improving the Protection of Trial Subjects
by Glenn Veit, JD, CIP, Copernicus Group IRB Chairperson To safeguard the rights, safety and welfare of human subjects, clinical research is a shared responsibility among sponsors, investigators, contract research organizations (CROs) and institutional review boards (IRBs). Central to this shared obligation is the meaningful review and communication of…READ MORE
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Protecting Vulnerable Populations During Research: Guidelines for safeguarding the health and welfare of children
by Yvonne Higgins, AB, CIP, Director, Quality Management According to federal regulations regarding human research, the principal investigator holds the ultimate responsibility for protecting the safety, rights and welfare of research subjects. Of particular importance is obtaining informed consent according to strict regulatory and ethical requirements. Complicating the issue,…READ MORE


