De-Risking Development with Specialized Data Strategies: From Trial Design to Submission

In today’s complex clinical landscape, data is the foundation of successful drug development. Yet, many sponsors still underestimate its strategic value, often treating data management as a downstream operational task rather than a core driver of scientific and regulatory success. This approach can result in costly inefficiencies, inconclusive trials, and regulatory delays.

In this on-demand webinar, MMS data and regulatory experts, along with industry leaders, discuss how biotech organizations can de-risk development by embedding specialized data strategies from the earliest stages — from trial design through submission. The panel explores how proactive, data-driven decision-making enables sponsors to anticipate regulatory needs, identify risks earlier, and accelerate timelines.

Key discussion points include:

• The importance of involving statisticians and data architects early in trial design and conduct to deliver stronger R&D outcomes.
• How data-focused partnerships, built on quality-by-design principles, enhance trial efficiency and regulatory readiness.
• Strategies to transform data from a tactical deliverable into a strategic asset that drives smarter, faster, and more successful submissions.

Led by:

Moderator: Ben Dudley, Chief Commercial Officer, MMS
Mary E. West, MS, SVP, Clinical Development Operations, Tectonic Therapeutic
Irving Dark, Biometrics Thought Leader
Aiden Flynn, Senior Vice President, Head of Strategic Statistical Consulting, MMS

Watch now to discover how leading biotech innovators are redefining data strategy to achieve stronger outcomes and sustainable success.