Synthetic Control Arm^®: The Smart External Control Arm Solution

Sponsors often experience unique and significant challenges with randomized trials:

• Randomization is not always possible due to ethical reasons or rarity of a disease
• Noncompliant use of the investigational agent, or similiar agent in the same class, by control patients
• Slow recruitment due to unacceptability of control treatment to patients
• Deciding which are the most promising products to advance in pipeline

Medidata AI is uniquely positioned at the nexus of historical clinical trial and real world data; with a platform that integrates disparate datasets. Our Synthetic Control Arm® (SCA) solution can bring significant value to your company’s trials and ultimately help to increase the probability of overall success of your key pipeline assets. SCA supports trial design choices to enhance or replace control arms for registrational trials or early phase studies. This improves decision making, accelerate enrollment and reduce clinical development costs.