External Control Arms

Accelerate clinical trials with validated synthetic control arms

Aindo enables the creation of robust synthetic cohorts to support faster, more efficient, and more ethical clinical studies.

Talk to our experts
Aindo helps pharma companies, CROs, and research organizations integrate external control arms while maintaining strong methodology, privacy, and regulatory compliance.
Accelerates clinical studies Reduce cost and recruitment burden Improve operational efficiency

With Aindo's AI evidence infrastructure, you can:

 
Generate robust synthetic cohorts
Turn historical and real-world data into statistically sound cohorts for credible clinical comparisons.
Reduce execution timelines
Overcome recruitment delays, data access constraints, and operational complexity to start studies faster.
Enable multi-site and international studies
Combine evidence from partners, institutions, and geographies without transferring personal data.
Improve representativeness and statistical power
Strengthen analyses by including rare, underserved, or hard-to-recruit populations.
 
 
 
 
 
Built for Europe's advanced healthcare regulations.
 
Designed for modern trials and aligned with the highest European standards for health data and clinical research.
Europrivacy
Europrivacy
Art 42 GDPR
ISO 9001 Quality
ISO 9001
Quality
ISO 27001 Information security
ISO 27001
Information security
Gender Equality
Gender Equality
UNI PDR 125:2022
NIST Cybersecurity Framework
NIST
Cybersecurity & privacy
 
 
 
 
 
 
 
Use synthetic control arms to
 
     
  • Support single-arm trials and rare disease studies
    •  
  • Strengthen comparative effectiveness analyses
    •  
  • Reduce placebo exposure
    •  
  • Improve statistical power and cohort representativeness
    •  
  • Enable faster regulatory submissions
    •  
 
 
 
 
 
 
 
In oncology, synthetic data means faster trials with greater respect for patients — who can access potentially effective treatments sooner.
Gennaro Daniele, PhD
Gennaro Daniele, PhDFull Professor at Policlinico Gemelli
Synthetic patient cohorts preserve clinical characteristics without identifiable information — enabling faster and safer trials, giving patients earlier access to experimental therapies.
Alfonso Piciocchi, PhD
Alfonso Piciocchi, PhDChief Scientific Officer (CSO), Fondazione GIMEMA Franco Mandelli
By building synthetic control arms from real-world data, we can design trials requiring fewer control patients and reduce development timelines — giving patients faster access to transformative therapies.
Mark Winderlich, PhD
Mark Winderlich, PhDHead of U.S. R&D, MorphoSys
AI-generated synthetic cohorts provide robust external comparators to evaluate new therapies more rapidly when large randomized trials are not feasible.
Eddy Saad, MD
Eddy Saad, MDChair Biomechanics, Dana Farber Cancer Institute
Synthetic patients can accurately mimic real-world patient sets and produce survival analyses closely aligned with real-world data.
Jan-Niklas Eckardt
Jan-Niklas EckardtDoctor of Medicine, Hematologist/Oncologist, Universitätsklinikum Carl Gustav Carus, Dresden
External control arms are increasingly used in oncology regulatory submissions and can provide supportive evidence for clinical efficacy.
Xiaomeng Wang
Xiaomeng WangAssociate Professor, Centre for Vision Research
Real-world external control arms can help demonstrate comparative effectiveness when randomized evidence is difficult to generate.
Sanjay Popat, MD
Sanjay Popat, MDProfessor of Thoracic Oncology, Institute of Cancer Research
 
 
 
Partner with Aindo
Are you a clinical innovator looking for faster, stronger, and more ethical trial design solutions?
Contact usRead our white paper