Newsletter | September 16, 2025

09.16.25 -- Strengthen Protocol Certainty

How To Double High-Performing Site Count In A Priority Indication

A top 10 biopharmaceutical company wanted to expand its site list in a priority indication and better understand how existing sites in their database performed. Find out what happened next.

 

A Sponsor Increased Their Site Count By 50% In A Rare Disease Clinical Trial

As a mid-sized biopharmaceutical company embarked on an upcoming rare disease clinical trial, they struggled with patient recruitment and site selection. Explore how the sponsor chose high-performing sites based on reliable data to set their trial up for success.

 

Simulants: A Generative AI Algorithm For Generating Synthetic Clinical Data

Generative AI is offering a breakthrough with the creation of synthetic data. Medidata’s Simulants generative AI algorithm exemplifies this innovation, leveraging one of the industry’s largest standardized trial data repositories to produce high-fidelity, regulatory-grade synthetic datasets.

 

The Regulatory Grade External Control Arm To Power Your Clinical Trials

Examine the growing role of external control arms in clinical trials, including the distinctions between control groups that use real-world data and those that use historical clinical trial data.

 

Synthetic Control Arm In Clinical Trials

This white paper features a series of case studies discussing the concept of the Synthetic Control Arm (SCA), a type of external control that's generated to improve the interpretation of uncontrolled trials, which can enable better product development decisions.

 

Intelligent Clinical Trials: Enhance Study Design And Live Forecasting

Clinical trials face persistent challenges in patient recruitment, retention, and protocol complexity. To address these obstacles, the integration of standardized, regulatory-grade clinical trial data has become central to advancing trial design and execution.