Tag: HIPPA

In this episode, Tom Fox welcomes Edye Edens about launching her Life Sciences Law Group (“Eedee Law”) after years of contracting in life sciences compliance across multiple firms.

Edye explains she founded the firm to better align her practice with supporting clinical trial sites, vendors, and academia, which often lack the budgets and in-house legal resources of sponsors and CROs. She describes a multidisciplinary team model that includes non-attorney quality, TMF, regulatory, and inspection-readiness professionals with deep study-operations experience, enabling rapid, practical support at different price points, including fractional engagements and urgent FDA inspection support. Edye outlines four core client segments: independent sites/site networks, academic medical centers’ research compliance functions, NCI-designated cancer centers, and vendors entering clinical trials who need guidance on Part 11, HIPAA, QMS, and vendor qualification. She discusses growing AI-related client needs, emphasizing evolving regulatory expectations and “compliance at the speed of business,” and shares how to connect via website, LinkedIn, and email.

Key highlights:

• Building A Different Firm
• Indy Roots National Reach
• Lessons From Academic Medicine
• AI Vendors And Regulation

Resources:

Edye Edens on LinkedIn

Eedee Law

Tom Fox

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For more information on the use of AI in compliance programs, Tom Fox’s new book, Upping Your Game, is available. You can purchase a copy of the book on Amazon.com.

To learn about the intersection of Sherlock Holmes and the modern compliance professional, check out Tom’s latest book, The Game is Afoot-What Sherlock Holmes Teaches About Risk, Ethics and Investigations on Amazon.com.