We empower sponsors, CROs, and research teams to streamline every phase of trial development – from protocol generation to submission-ready reports – while maintaining rigorous regulatory compliance
High-Level Introduction
High-Level Introduction
Our Intelligent Clinical Trial Development Platform harnesses advanced natural language processing, real-world data integration, and automated workflows to bring unprecedented speed and accuracy to clinical research. Whether you’re optimizing protocol design, automating essential trial documents, or generating final reports, our unified system ensures consistency, cuts down on manual labor, and delivers real-time insights at every step.
High-Level Introduction
Our Intelligent Clinical Trial Development Platform harnesses advanced natural language processing, real-world data integration, and automated workflows to bring unprecedented speed and accuracy to clinical research. Whether you’re optimizing protocol design, automating essential trial documents, or generating final reports, our unified system ensures consistency, cuts down on manual labor, and delivers real-time insights at every step
Key Features
AI-Powered Trial Design
Leverage historical trials, medical literature, and real-world evidence to create robust, data-driven protocols. Our automated engines suggest optimal inclusion/exclusion criteria, endpoints, and sample size calculations for faster, more effective study launches.
Automated Document Creation
Save countless hours with automatic drafting of core study documents - Informed Consent Forms, Statistical Analysis Plans, Investigator Brochures, and more. Each document remains synchronized with the latest protocol changes, reducing errors and ensuring global regulatory compliance.
Seamless TMF & Report Generation
Easily maintain an up-to-date Trial Master File (TMF) and generate thorough Clinical Study Reports (CSRs) that align with ICH E3 and local authority requirements. Built-in quality checks, role-based access, and audit trails guarantee transparent, inspection-ready processes.
SAS Programming & Data Intelligence
Our advanced automation module translates Statistical Analysis Plans (SAPs) directly into SAS code, speeding up the generation of tables, listings, and figures (TLFs) without sacrificing quality or consistency. Real-time validation ensures every data point is traceable from source to final output.
AI-Powered Trial Design
Leverage historical trials, medical literature, and real-world evidence to create robust, data-driven protocols. Our automated engines suggest optimal inclusion/exclusion criteria, endpoints, and sample size calculations for faster, more effective study launches
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Why Partner With Us?
Accelerated Timelines: Reduce trial setup and documentation weeks into days
Enhanced Quality: Minimize discrepancies and improve data integrity through standardized, AI-led processes.
Regulatory Confidence: Rely on compliance checks and pre-validated templates that address local and global requirements
Future-Proof Solution: Scale to multiple therapeutic areas, adapt to new regulations, and integrate seamlessly with your existing EDC and analytics tools
More offerings
Lead with insight. Scale with intelligence.