Indianapolis, IN – January 20, 2026 – Edye Edens Life Sciences Law Group (EEDEE Law) announced today a significant expansion of its clinical research legal and operational support services, alongside the addition of Helen Montevago, MA, CCRP, a seasoned clinical research leader with nearly two decades of experience in oncology and multidisciplinary trial management.

The firm's expanded service offerings now provide comprehensive, specialized support across four critical sectors of the clinical research ecosystem: Academic Medical Centers & HRPPs, Cancer Centers, Independent Research Sites & Site Networks, and Clinical Trial Technology Vendors.

"Clinical research teams are facing increasingly complex regulatory demands while trying to maintain operational efficiency," said Edye Edens, founder of EEDEE Law. "These expanded services reflect what we're hearing from the field: Investigators, compliance teams, and research organizations need practical, real-time support that understands both the legal requirements and the operational realities of running trials. They need partners who've actually survived FDA audits and managed sites on tight budgets, not just legal theory from the sidelines."

The new service lines include real-time inspection and audit support, end-to-end study startup coordination, regulatory communications management, eTMF and ISF remediation, and FDA IND support. EEDEE Law provides hands-on assistance that addresses what actually slows down research, from IRB essential documentation to amendment management, vendor qualification, contract negotiation, and study close-out coordination.

Helen Montevago brings hands-on expertise spanning feasibility through close-out, with a reputation for collaborative leadership and unwavering commitment to inspection readiness. She has built her career on mentoring teams, strengthening quality systems, and ensuring that clinical operations align with both regulatory expectations and organizational goals.

"Helen embodies the practical, collaborative approach that defines EEDEE Law," Edens added. "She's worked in the trenches of clinical research and understands the pressure points investigators and research teams face every day. She knows what it's like when timelines are tight and budgets are tighter. Her addition strengthens our ability to deliver even more responsive, expert support to our clients."

As the firm continues to grow, EEDEE Law will announce additional team members in the coming months who share this commitment to bridging legal expertise with real-world operational knowledge.

The expansion positions EEDEE Law to serve as a comprehensive partner for research organizations navigating the full lifecycle of clinical trials, from protocol development through regulatory close-out and beyond.

About EEDEE Law

Edye Edens Life Sciences Law Group is a specialized legal practice dedicated to supporting clinical research organizations, academic medical centers, independent sites, and life sciences innovators. Founded by Edye T. Edens, JD, MA, CIP, CCRP, who's been a clinical research administrator and clinical trial compliance officer alongside being a licensed attorney, the firm provides practical legal counsel grounded in real-world research operations experience across FDA, OHRP, ORI, GCP, and global regulatory frameworks.

For more information, visit www.eedeelaw.com.

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