Lauren Nikodemos

Associate

  • JD, New York University School of Law, 2018
  • MA, New York University Graduate School of Arts and Science, 2013
  • BA, cum laude, Harvard College, 2008

Qualifications

  • Massachusetts, 2018
  • Boston Bar Association
  • American Health Lawyers Association
  • Public Responsibility in Medicine and Research (PRIM&R))

Lauren Nikodemos

Associate

Lauren Nikodemos is an associate in the firm’s health care group. Lauren assists a range of health care clients, such as hospitals, clinical laboratories, pharmaceutical companies and universities, on clinical research, regulatory and compliance matters.

Experience

Clinical Research

  • Advising research institutions and industry sponsors regarding research policy and compliance issues, including with respect to human subjects research regulations, genetic testing, and data privacy.
  • Drafting and negotiating clinical trial agreements, observational study agreements, and related research services agreements for both sponsors and research sites, as well as advising sponsors and research sites on employee trainings and negotiation guidelines for research agreements.

Research Misconduct

  • Counseling research institutions and industry clients in connection with internal and external investigations involving allegations of research misconduct.
  • Advising research institutions on risk-mitigation strategies to ensure appropriate use of federal research funding.

Compliance

  • Assessing and providing guidance on hospital and university compliance programs and research integrity functions. 
  • Advising clinical laboratories and diagnostic test developers on the regulatory implications of COVID-19 testing arrangements.

Not-for-Profit Governance

  • Drafting and revising bylaws of not-for-profit entities to incorporate statutory updates and reflect best practices in corporate governance.
  • Advising not-for-profit boards on duties and various governance questions, including compliance with state not-for-profit law and conflict of interest requirements.
 

Publications

  • JD, New York University School of Law, 2018
  • MA, New York University Graduate School of Arts and Science, 2013
  • BA, cum laude, Harvard College, 2008

Qualifications

  • Massachusetts, 2018
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