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CGIRB Quality Management Director Yvonne Higgins to speak in Singapore
Copernicus Group IRB Quality Management Director Yvonne Higgins, CIP will speak at the Asia Pacific Research Ethics Conference in Singapore this March, CGIRB announced today. Higgins will present on Quality Management and Quality Improvement in Research – one of the featured tracks of the March 7-9 conference at the Grand Copthorne…READ MORE
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Copernicus Group IRB’s Veit, Higgins speak at PRIM&R conference
Two members of the Copernicus Group IRB team spoke at the 2011 Advancing Ethical Research Conference in National Harbor, Md., on Dec. 4. CGIRB Chairperson Glenn Veit, JD, CIP, spoke on “Sponsor Responsibilities in Unanticipated Problems and Adverse Event Reporting.” His presentation reviewed new FDA regulations on adverse event…READ MORE
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Press Release: Copernicus Group IRB named a Training Magazine Top 125 company
CGIRB sits among top national, international brands Dec. 6, 2011, Research Triangle Park, N.C. – Copernicus Group IRB (CGIRB), a leading independent institutional review board, 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…READ MORE
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CGIRB Associate Project Manager Guest Speaker at Campbell University
Melody Sawyer, Associate Project Manager at Copernicus Group IRB, spoke to undergraduate students in Campbell University’s Pharmacy School in Buies Creek, NC on Wednesday, November 9, 2011. Sawyer’s lecture included a general overview of the IRB process, with a focus on Human Subject Protection history and the IRB role in…READ MORE
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CGIRB’s Director, Quality Management Featured Speaker at OHRP Quality Assessment Workshop
Yvonne K. Higgins, Director, Quality Management at Copernicus Board IRB spoke at an OHRP Quality Assessment Workshop on Wednesday, October 5, 2011. The workshop was held at the Durham Convention Center in Durham, NC and featured Higgins’ firsthand account of how one institution brought about improvement of its human…READ MORE
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Press Release: Copernicus Group IRB Named Finalist for NCTA 21 Award
“Leading Environmental Steward Company Award” category November 1, 2011, Research Triangle Park, NC — Copernicus Group IRB (CGIRB), a leading independent institutional review board, today announced it has been named a finalist in the 2011 North Carolina Technology Association (NCTA) 21 Awards. CGIRB was selected in the “Leading Environmental…READ MORE
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Press Release: Copernicus Group IRB Webinar
CGIRB case study with Duke University Clinical Research Unit October 12, 2011, Research Triangle Park, NC – Copernicus Group IRB will be leading a webinar on Tuesday October 18, 2011. This is a free educational webinar entitled, “Reducing the Barriers to the Conduct and Oversight of Clinical Trials: A…READ MORE
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CGIRB 16th Anniversary
July 1st, 2012 – July 1st, 2012 at Durham, NC – July 1st marks the 16th anniversary for CGIRB! Established in July 1996, Copernicus Group IRB (CGIRB) is an independent institutional review board (IRB or “Board”) organized and operating in compliance with regulations governing institutional review boards set forth in 21 CFR and ICH guidelines, as well as 45 CFR when…READ MORE
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CGIRB to attend MAGI East
May 20th, 2012 – May 23rd, 2012 at Arlington, VA – CGIRB will attend MAGI East conference in Arlington Virginia on May 20- 23, 2012 90+ sessions and workshops in seven tracks: sponsor operations, site operations, regulatory compliance, contracts, budgets & billing, quality and special topics. About MAGI: 8,000+ members represent clinical research sponsors, sites and CROs. Our objective is to standardize best…READ MORE
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AAMC Annual Meeting
November 2nd, 2012 – November 7th, 2012 at San Francisco, CA – CGIRB will attend the Association of American Medical Colleges (AAMC) in San Francisco, California on Nov 2-7. The AAMC serves and leads the academic medicine community to improve the health of all. Founded in 1876 and based in Washington, D.C., the Association of American Medical Colleges (AAMC) is a not-for-profit…READ MORE
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MAGI West
October 21st, 2012 – October 24th, 2012 at San Diego, CA – CGIRB will attend MAGI West conference in San Diego, CA on October 21-24. The MAGI West conference will include over 90 sessions and workshops in seven tracks; sponsor operations, site operations, regulatory compliance, contracts, budgets & billing, quality and special topics. The conference also provides exceptional networking environment and activities. About…READ MORE
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Partnerships in Clinical Trials Orlando, FL
March 4th, 2012 – February 7th, 2012 at Marriott World Center, Orlando FL – CGIRB will attend the annual Partnerships in Clinical Trials conference in Orlando Florida at the Marriott World Center on March 4-7 The Partnerships in Clinical Trial events opens up with a choice of six diverse multi-speaker summits including; Virtual Clinical Trials Consortium, Outsourcing Strategies for Small and Mid-Size Pharma and Biotech, Innovation Strategies…READ MORE
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CGIRB to attend Post-Approval Summit at the Harvard Medical School in Boston.
May 1st, 2012 – May 2nd, 2012 at Harvard Medical School, Boston, MA – The Post-Approval Summit will be held on May 1-2 at Harvard Medical School. The annual summit focuses on strategies and best practices for demonstrating and improving the safety, effectiveness, value and quality of healthcare products and services through Phase IV studies, Patient Registries, Risk Management Programs and Quality Initiatives. Are you planning to…READ MORE
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Yvonne Higgins speaking in Singapore
March 7th, 2012 – March 9th, 2012 at Grand Copthorne Waterfront Hotel, Singapore. – CGIRB Quality Management Director Yvonne Higgins to speak at Asia Pacific Research Ethics Conference in Singapore Yvonne Higgins, Quality Management Director of Copernicus Group (CGIRB), will speak at The Asia Pacific Research Ethics Conference (APREC) on March 7th-9th, 2012 at the Grand Copthorne Waterfront Hotel in Singapore. Higgins track…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


