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Regulatory
Services
Positioning your TwinRCT for regulatory success
Our team has deep expertise in navigating the dynamic regulatory landscape of AI-powered clinical research. From supporting your interactions with regulatory agencies to providing language for protocols and statistical analysis plans, we're here to empower your success every step of the way—while prioritizing transparency, reproducibility, and trust in our technology.
European Medicines Agency and US Food and Drug Administration
The European Medicines Agency (EMA) qualified our PROCOVATM procedure, providing a regulatory framework for the application of TwinRCTs in Phase 2 and 3 clinical trials with continuous outcomes.
The FDA has stated that they concur with the EMA and that PROCOVA does not deviate from current guidance.
Read the EMA's qualification opinion
For these indications and more
See our digital twin generators
Alzheimer’s disease
Amyotrophic Lateral Sclerosis
Asthma
Atopic Dermatitis
COPD
Coronary Artery Disease
Crohn’s disease
Dyslipidemia
Frontotemporal dementia
Huntington's disease
Hypertension
Migraine
Obesity
Osteoarthritis
Osteoporosis
Parkinson's disease
Psoriasis
Psoriatic Arthritis
Rheumatoid Arthritis
SCI
Stroke
Type 2 Diabetes
Ulcerative Colitis
Alzheimer’s disease
Amyotrophic Lateral Sclerosis
Asthma
Atopic Dermatitis
COPD
Coronary Artery Disease
Crohn’s disease
Dyslipidemia
Frontotemporal dementia
Huntington's disease
Hypertension
Migraine
Obesity
Osteoarthritis
Osteoporosis
Parkinson's disease
Psoriasis
Psoriatic Arthritis
Rheumatoid Arthritis
SCI
Stroke
Type 2 Diabetes
Ulcerative Colitis