Root Causes, Part 2: The Translation Problem Behind Clinical Trial Execution

By Rachel Grabenhofer, Chief Editor, Clinical Supply Leader

How Upstream Decisions Shape Clinical Supply Outcomes: A Five-Part Video Series

In the second installment of our Root Causes series, Elena (Ella) Sinclair and Tatyana Matveeva, Ph.D., explore the "translation problem" that emerges when protocol assumptions move from the planning phase into real-world execution. Through examples ranging from patient eligibility criteria to first-patient delays, they examine how seemingly reasonable assumptions can create unexpected operational consequences downstream.

(Revisit part 1 here)

Main Highlights

• Why protocol requirements often mean different things to different functions
• How operations and manufacturing evaluate trial feasibility before execution begins
• The "translation gap" between scientific intent and operational reality
• Why clinical operations and supply teams are often measured against different objectives
• How a single assumption about patient eligibility can affect enrollment, timelines, and drug supply
• Why communication alone cannot solve every execution challenge
• The difference between communication gaps, incentive gaps, and structural gaps
• How translation failures can create downstream supply, manufacturing, and enrollment consequences

Watch now:

About the Experts

Elena (Ella) Sinclair is a principal consultant at FlexPoint Bio, focused on operational strategy and logistics, clinical vendor outsourcing, and clinical quality assurance. She’s held various leadership roles, including as CEO and co-founder of the Life Science & Tech Consultants Association, and as both Seattle Chapter Chair of the membership committee and board member for the Women in Bio organization. She also served in clinical trial and operations management and director roles for five years at Sangamo Therapeutics – after 17+ years in clinical research at UT Southwestern Medical Center.

Tatyana Matveeva, Ph.D., is a neuroscientist with a background in systems and molecular neuroscience. She is now director of cGMP operations for cell therapy and regenerative medicine at a major university and connected hospital. There, she helped build a GMP cell therapy facility from the ground up — creating the full GMP infrastructure, programs, documentation, and training required to support early‑phase clinical trials.

What’s Next – Root Causes, Part 3: The Hidden Cost of Clinical Supply Work That Doesn't Move Trials Forward

Clinical trial teams spend significant time reconciling documents, validating assumptions, and maintaining planning processes. Part 3 examines the hidden costs of that work that consumes resources without necessarily moving a trial forward.

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