Tech Mahindra Clinical Document Studio powered by Kitsa

Overview:

Tech Mahindra Clinical Document Studio powered by Kitsa is an enterprise-grade AI platform designed to transform clinical trial protocol and regulatory document development for Sponsors, CROs, and biotech companies. This joint offering combines Tech Mahindra’s life sciences transformation expertise and AWS-native deployment capabilities with Kitsa’s AI-powered Protocol Development Studio purpose-built for structured clinical authoring. The platform supports intelligent authoring, benchmarking, validation, and collaboration across the full spectrum of regulatory documentation.

Comprehensive Regulatory Coverage:

• Clinical Trial Protocols (Phases I–IV)

• Investigator’s Brochure (IB)

• Informed Consent Forms (ICF)

• Clinical Study Reports (CSR)

• Statistical Analysis Plans (SAP)

• IND / NDA / BLA modules (CTD-aligned structure)

• Global regulatory submission packages (FDA, EMA, MHRA, CDSCO and others)

Built on AWS for Enterprise-Grade Performance:

• Amazon EKS for scalable orchestration

• Amazon EC2 for AI workloads

• Amazon RDS and Amazon S3 for secure document storage

• Enterprise-grade encryption, identity, and audit logging Ensures regulatory-grade compliance, scalability, and secure collaboration.

Key Features:

• Intelligent Protocol Authoring – AI-guided drafting of objectives, endpoints, eligibility criteria, and statistical frameworks.

• Benchmarking & Disease Intelligence – Compare protocol parameters against historical trials to optimize feasibility and design.

• Regulatory-Ready Documentation – Generate structured content aligned to IND/NDA/CTA submission requirements.

• Collaborative Workflow Engine – Multi-user authoring, review, and version control.

Benefits:

• Up to 40% reduction in protocol development timelines

• Improved first-pass regulatory quality

• Standardization across clinical programs

• Secure, scalable AWS-native infrastructure

• Future-ready AI-enabled regulatory automation