InterClin Ai is an AI-enabled clinical development platform designed to streamline the entire clinical trial process, from study design to regulatory submission. By integrating intelligent tools, it assists drug developers in protocol creation, data management, statistical analysis, medical writing, and compliance with regulatory standards.
Key Features and Functionality:
- Protocol Development: Generates ICH M11-compliant protocols from study synopses, reducing the need for amendments through built-in complexity scoring.
- Statistical Analysis Plans (SAPs): Creates comprehensive SAPs, including endpoint definitions, analysis methods, and mock Tables, Figures, and Listings (TFLs).
- Investigator Brochures: Drafts sections per ICH M4 guidelines, covering nonclinical summaries, clinical pharmacology, safety data, and benefit-risk assessments.
- Data Management: Automatically maps, transforms, and validates CDISC-compliant datasets, including SDTM and ADaM specifications, ensuring data integrity.
- Medical Writing: Produces ICH E3-compliant Clinical Study Reports (CSRs) and Development Safety Update Reports (DSURs) efficiently.
- Regulatory Submission: Assembles eCTD packages, performs validation against over 2,000 conformance rules, and facilitates gateway submissions to regulatory bodies.
Primary Value and User Solutions:
InterClin Ai addresses the complexities of clinical development by automating and integrating key processes, thereby reducing manual effort, minimizing errors, and accelerating timelines. Its AI-driven approach ensures compliance with industry standards and regulatory requirements, enhancing data quality and submission success rates. By providing a comprehensive suite of tools, InterClin Ai empowers clinical teams to focus on strategic decision-making and innovation, ultimately bringing therapies to market more efficiently.
