Synthetic Control Arm®
When a concurrent control arm isn’t feasible or appropriate, results are harder to interpret, slowing decisions and increasing risk.
An external control arm (ECA) uses patient data from outside the trial as a scientifically rigorous comparator. Medidata Synthetic Control Arm® delivers that evidence using validated, patient-level clinical trial data, so you can move forward with confidence when randomization isn’t an option.
Advance Your Trials with Clinical-grade Evidence
Validated, patient-level data from controlled studies
With endpoints and covariates captured as originally collected
Built for scientific credibility
Not reconstructed from fragmented real-world data
Turn Data into Decisive Advantage
Regulatory Confidence
Strengthen Your Regulatory Submission
Support single-arm Phase II studies, accelerated approvals, and select confirmatory Phase III trials with credible external comparators.
Medidata Synthetic Control Arm® enables direct outcome comparisons against standard of care, helping you justify next-phase decisions, augment or replace control arms, and engage regulators with confidence.
Our team brings deep regulatory, biostatistics, data science, and oncology expertise, including former FDA, pharma, and academic leaders.
AWARDS
2023 Best in Real-world Evidence
INDUSTRY RECOGNITION
2021 Best AI-based Solution for Healthcare
FAQ
What data sources does Medidata use to construct a synthetic control arm?
Medidata Synthetic Control Arm® is the only external control arm created using cross-industry historical clinical trial data from over 38,000 clinical trials and 12 million patients. Unlike real-world data (RWD) from electronic health records, this solution uses de-identified patient-level data complete with covariates and endpoints exactly as they were captured in clinical protocols, providing a standard of data quality that accurately reflects control groups for your specific patient subpopulation.
Can Medidata Synthetic Control Arm® be used for regulatory submissions?
Yes. The solution is designed to support regulatory interactions, such as enhancing single-arm Phase II trials, supporting accelerated approval submissions, and aiding confirmatory Phase III trials in certain indications.
Medidata’s team includes former FDA officials and regulatory experts who work as an extension of your team to ensure the external control group is scientifically rigorous and fit for regulatory purpose.
How does the solution accelerate clinical trial timelines?
By reducing or eliminating the need to recruit a concurrent control group, SCA significantly eases patient recruitment and retention challenges, especially in rare or life-threatening diseases where standard-of-care treatments are inadequate.
This approach can drastically reduce enrollment requirements; for example, Medidata Synthetic Control Arm® helped Medicenna reduce their Phase III registration trial enrollment by two-thirds.
How does Medidata Synthetic Control Arm® differ from using literature-based controls?
Unlike relying on aggregate data from medical literature, Medidata Synthetic Control Arm® leverages patient-level data to precisely choose matching control patients. Statistical methods are applied in a dynamic matching process using baseline demographics and disease characteristics to generate a historical patient group that closely matches the experimentally treated patients, ensuring a more scientifically valid comparison.
Does Medidata offer training for its clients and partners?
Yes. Medidata offers a variety of training options for our clients and partners, including both self-paced and instructor-led courses. To learn more about available courses and to access our resources, please visit the Medidata Global Education and Training section.