In today’s evolving regulatory landscape, the concept of estimands has become pivotal in aligning study objectives, design, and statistical interpretation. Yet, for many in clinical development, its implications remain complex and often misunderstood.

This white paper from MMS experts demystifies the estimand framework, helping clinical, regulatory, and statistical teams integrate it effectively into their trial planning. Learn how clear estimand definitions not only reduce risk and bias but also enhance the scientific rigor and regulatory acceptability of your studies.

Whether you’re leading study design, statistical analysis, or regulatory submissions, this guide offers the insights needed to stay compliant, confident, and ahead of industry expectations.

Estimands: Opportunity or Risk for Drug Developers?

Download your free Whitepaper today ↓

Key Benefits / What You’ll Learn

• Clarify how the ICH E9(R1) estimand framework reshapes trial objectives and analysis.
• Understand the five key strategies to address intercurrent events (ICEs) and their design implications.
• Learn how early evaluation of estimands strengthens regulatory alignment and decision-making.
• Explore how simulation-based design tools like KerusCloud® reduce risk and optimize development timelines.
• Identify opportunities to improve data integrity, transparency, and overall trial success.

Developed by MMS experts with over 25 years of experience guiding global sponsors in study design, data strategy, and regulatory submissions.