About this episode

Edye Edens discusses the launch of her Life Sciences Law Group and the unique compliance needs in the life sciences sector.

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…

People in this episode

Host: Thomas Fox

Guest: Edye Edens

Topics covered

• life sciences compliance
• clinical trials
• legal resources
• AI in compliance
• multidisciplinary teams

Keywords

• life sciences
• compliance
• clinical trial sites
• regulatory
• AI
• HIPAA
• QMS

Mentioned in this episode

Organizations: Eedee Law, NCI, FDA

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