Payal P. Cramer

Counsel

Atlanta
T +1.404.256.8433
F +1.404.459.5734

Overview

With a concentration in the clinical trial and data-based research space, Payal counsels research institutions, healthcare providers and pharmaceutical and device manufacturers on each aspect of the conduct of human subject research. Her experience includes Food and Drug Administration compliance, Office of Human Research Protections compliance, HIPAA compliance, guidance for research-related Medicare billing, federal grant compliance, contract negotiation and guidance on structuring relationships between institutions, researchers, CROs and sponsors.

Select Experience

  • Counseled a large healthcare provider in establishing a centralized clinical research program with an infrastructure geared toward regulatory compliance.
  • On behalf of researchers, commercial sponsors and contract research organizations, prepared, reviewed and negotiated clinical trial agreements, investigator agreements, research services agreements and other related agreements.
  • Counseled researchers on human subjects protections matters.
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Experience

  • Counseled a large healthcare provider in establishing a centralized clinical research program with an infrastructure geared toward regulatory compliance.
  • On behalf of researchers, commercial sponsors and contract research organizations, prepared, reviewed and negotiated clinical trial agreements, investigator agreements, research services agreements and other related agreements.
  • Counseled researchers on human subjects protections matters.
  • Advised researchers on health information privacy and use of patient data for research purposes.
  • Provided guidance to manufacturers on federal Anti-Kickback Statute compliance.

Recognitions and Memberships

Recognitions

  • The Best Lawyers in America® (2022)
    • Georgia: Health Care Law

Memberships

  • Georgia Bar: Health Law Section
    • Executive Committee Member
  • American Health Lawyers Association: Life Sciences Practice Group

Pro Bono

  • Through the Pro Bono Partnership of Atlanta, advises nonprofits regarding health information privacy issues.

Admissions

  • Georgia

Education

  • J.D., Emory University School of Law
  • M.P.H., Boston University School of Public Health
  • B.S., Emory University

Languages

  • Gujarati