Leah Guidry

J.D., M.A. Contact Leah Guidry

Leah Guidry

Leah has more than three decades of experience advising health systems, hospitals, academic health centers, physician groups and life sciences organizations on complex compliance issues.

About Leah

Transformation is the ability to address the most pressing challenges in a manner that harnesses the best the organization has to offer while pressing for change that promotes growth.

Leah is a compliance expert with more than 30 years of experience working with health systems, hospitals, academic health centers, physician groups, and pharmaceutical and device manufacturers. She specializes in clinical research matters, helping institutions navigate research infrastructure development, strategy development and execution, and regulatory compliance.

Throughout her career, Leah has:

  • Led multiple initiatives to assess institutions’ compliance risks and the efficacy of their compliance structures.
  • Managed teams responsible for evaluating organizations’ clinical research billing operations and infrastructure.
  • Conducted numerous internal investigations to determine the validity of alleged regulatory compliance violations.

Prior to joining Huron, Leah practiced law in both New York and Washington, D.C. As a healthcare attorney, she focused on assisting large healthcare systems in their efforts to comply with complex state and federal regulatory systems while also meeting their business goals.

Leah is a frequent speaker at national and regional conferences sponsored by the American Health Lawyers Association (AHLA), the Society for Research Administrators (SRA) and the National Council of University Research Administrators (NCURA) on topics related to clinical research and healthcare compliance issues.

Areas of Expertise

  • Advisory Services
  • Managed Services
  • Huron Research Suite
  • Technology

Industries

  • Education

Education & Certifications

  • J.D., Touro College, Jacob D. Fuchsberg Law Center
  • M.A., Chapman University
  • B.S., Louisiana State University

Insights

  • Food and Drug Administration NPRM Webinar Series

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    Recordings of Huron’s webinars, which provided summaries of the key portions of the FDA’s NPRMs and an opportunity for questions, feedback, and discussion.

  • OSTP Issues August Update on Research Security

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    Huron details and explains the White House Office of Science and Technology Policy update of the implantation of NSPM-33 that was announced August 31, 2022

  • OSTP Foreign Interference and Research Security Guidance

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    On 1/4/22 the OSTP released guidance for federal research agencies to spend 120 days developing a set of model grant forms to use by researchers across funding agencies

  • Resources for organizations defining their approach to research security

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    Research Security and Foreign Interference guidance, alerts & newly released information from the US government for higher education and healthcare

  • Research Enterprise Impacts and Opportunities

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    Huron provides a framework for guiding higher education’s evolution through this pandemic while still focusing on institutional stabilization.

  • Research Compliance: A Resource Library

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    As research institutions face economic pressures and new policies and legislation, Huron’s compliance resources provide insight into how to reduce the risk of institutional noncompliance.

  • Foreign Influence Client Alert

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    On July 10, 2019, the NIH released a notice regarding policies on Other Support, financial conflicts of interest and foreign components.

  • A Self-Assessment for Internal Controls and the Single Audit

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    This self assessment for internal controls guide will help you understand your own controls before auditors arrive.

  • Why Your Institution Should Conduct a Coverage Analysis

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    Huron's Leah Guidry provides insight into why institutions should conduct Medicare coverage analysis as part of clinical research compliance programs.

  • Outsourcing as a Strategy to Reduce your Research Administrative Burden

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    View our webinar for a detailed discussion and demo of how Huron's industry-leading Research Office solution can address your institution's dynamic research infrastructure service needs.

  • Research Compliance Podcast Series

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    Huron’s Research Compliance Podcast will keep your institution informed on current events and best practices.

  • COVID-19 HRPP Toolkit Supplemental Documents Release

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    This series of HRPP toolkit supplement documents is being released to provide HRPPs with additional resources to manage research during the COVID-19 pandemic.

  • Client Alert: FDA Issues Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic

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    On March 18, 2020, the FDA issued guidance for industry, investigators and IRBs related to the conduct of clinical trials during the COVID-19 pandemic.

  • COVID-19 Federal Guidance for Grant Applicants and Recipients

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    The issued guidance provides grantees clarity regarding proposal submission practices, availability of funding and more for COVID-19 research.

  • Programmatic vs. Operational (Big "C" vs. Little "c") Compliance Webinar

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    In part one of Huron’s compliance webinar series, Leah Guidry, Anne Pifer and Dr. Timothy Fournier discuss programmatic vs. operational compliance.

  • NIH Extends Effective Date for Use of sIRB

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    The NIH extended the sIRB effective date from September 25, 2017, to January 25, 2018.

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