Case Study

How MMS Used Real World Data to Build a Validated Synthetic Control Arm for an Oncology Trial

Learn how advanced analytics and structured RWD evaluation helped a biotech sponsor reduce enrollment burden and accelerate clinical development.

In highly targeted oncology programs where patient populations are small and randomized control trials are difficult to conduct, real world data can play a powerful role in strengthening evidence generation. This case study highlights how a biotechnology company partnered with MMS to evaluate and construct a synthetic control arm using a large real world data registry.

Created for clinical development teams, biometrics leaders, and RWE strategists, this resource explains the process, feasibility considerations, and regulatory context behind using RWD to support evidence in challenging oncology settings. It also demonstrates how rigorous methodology, predefined selection criteria, and advanced analytics can produce meaningful and defensible insights.

By reviewing the complete case study, you will learn how MMS identified the right patient cohort, aligned RWD with trial requirements, and generated a synthetic control arm that reduced burden, saved time, and created a pathway for more efficient clinical execution.

Key Benefits / What You’ll Learn:

  • Understand how MMS identified and filtered real world data to match strict eligibility and disease severity criteria.
  • Learn how predefined procedures and unbiased patient selection strengthen feasibility and regulatory alignment.
  • Explore how synthetic control arms can reduce recruitment challenges and support development in small or rare populations.
  • See the real impact including reduced study burden, faster timelines, and validated evidence to support an oncology clinical trial.

Developed by MMS data science experts who apply advanced analytics, proprietary algorithms, and rigorous RWE methodology to support clinical programs worldwide.

Access the Synthetic Control Arm Case Study

How MMS Used Real World Data to Build a Validated Synthetic Control Arm for an Oncology Trial
casestudy

How MMS Used Real World Data to Build a Validated Synthetic Control Arm for an Oncology Trial

Learn how advanced analytics and structured RWD evaluation helped a biotech sponsor reduce enrollment burden and accelerate clinical development.

Suggested For You

case study

July 8th, 2026

Operating as an Integrated Regulatory Writing and Submission Partner for Small and Mid-Size Pharmaceutical Companies

case study

June 30th, 2026

Turning Regulatory Pressure into a Strategic Partnership: Public Release of Clinical Information (PRCI) for a Large Biotech Organization

case study

December 10th, 2025

From Challenge to Confidence: How MMS Delivered 800+ High-Quality Narratives in Record Time

case study

December 4th, 2025

How MMS Modernized Pulmonary Data Models to Streamline Clinical Analysis and Improve Decision-Making

case study

December 1st, 2025

Expert Support for Regulatory Briefing Books that Strengthen Sponsor Defense Strategies

case study

November 28th, 2025

How MMS Scaled Biostatistics Expertise to Accelerate a High Priority Vaccine Program

case study

November 24th, 2025

Regulatory Expertise that Strengthens Global Market Success

case study

November 19th, 2025

How MMS Supported IDMC Operations to Ensure Integrity and Safety in a High Complexity COVID 19 Trial

case study

November 17th, 2025

Strengthen Early Phase Oncology Trials with Expert Biostatistical Support

case study

November 14th, 2025

Transforming Real-World Data into Regulatory-Ready Evidence with KerusCloud®

case study

November 12th, 2025

How One Sponsor Rescued an Underpowered Trial Using Simulation-Guided Design

case study

November 10th, 2025

Evaluating Biomarkers with KerusCloud®: Powering Precision in Early Clinical Decision-Making