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Advarra VP of Institutional Services & Strategic Consulting Contributes Virtual Trial Regulatory Perspectives to InSite

Advarra Vice President of Institutional Services & Strategic Consulting James Riddle contributed to InSite, The Global Journal for Clinical Research Sites in the article Site Solutions Summit Reflections: A Regulatory Look into Virtual Trials.

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Updated IRB Handbook Now Available

Advarra has updated its IRB Handbook for Investigators, Institutions, Sponsors, and Sponsors’ Representatives to incorporate Canadian regulations and to update certain policies and processes to align with current practices.

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ACRP Appoints Advarra Executive Sergio Armani to Board of Trustees

The Association of Clinical Research Professionals (ACRP) has appointed Sergio Armani, Advarra VP of Business Development, to its Board of Trustees. The appointment is effective January 1, 2020.

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Holiday Meeting Schedule – Winter Holidays

Advarra’s offices will be closed Wednesday, December 25, through Wednesday, January 1. During this time, the IRB and IBC will not meet.

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Advarra Biosafety Director Contributes to Lab Manager Magazine

Advarra Director of Biosafety Services Dan Eisenman recently contributed to an article in Lab Manager Magazine

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Advarra Announces Intent to Acquire Forte, Market-Leading Provider of Clinical Technology Solutions

Advarra is pleased to announce the intent to acquire Forte, the industry’s leading provider of standards-based clinical research technology solutions.

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Bloomberg Law Features Advarra Chief Compliance Officer on New Ethics for Fitbit Data

Advarra Chief Compliance Officer and Institutional Official Michele Russell Einhorn was recently featured in Bloomberg Law on Your Fitbit Data Means New Ethics Conundrums for Clinical Trials.

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Operating Schedule (9/16-9/17) – Advarra Operations Summit

Advarra’s Regulatory and Operations teams will be out of office on September 16 and 17, 2019, for an off-site, team customer service training.

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Advarra Announces Recapitalization with Investment from Genstar Capital

Transaction to Accelerate Growth in Industry-Leading Compliance Business Focused on Increasing Safety and Efficiency in Clinical Trials

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I-ACT for Children Selects Advarra as Central IRB for Its Pediatric Clinical Trial Network

Advarra announced today that it has been selected by the Institute for Advanced Clinical Trials for Children (I-ACT for Children) to provide central institutional review board (IRB) services to the organization’s pediatric clinical trial site network.

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NIH Guidelines Revised to Streamline Oversight of Gene Therapy Research

NIH OSP has revised the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules to eliminate duplicative regulatory oversight.

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Note to File Re: Statement of Investigator, Form FDA 1572 2019

On May 1, 2019, all new studies submitted will be managed under Advarra’s FDA/OHRP registration. All studies previously under Quorum Review FDA/OHRP registration will fall under the Advarra FDA/OHRP registration once the RIB oversight transfer is complete.

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