In an industry where compliance oversight can derail clinical trials, Project Path delivers control, predictability, and peace of mind with GxP-compliant intelligent workflows.
Project Path is purpose-built for the unique requirements of biotech and pharma, delivering GxP compliance, validated AI, and regulatory-ready workflows.
Every workflow is designed with 21 CFR Part 11 compliance in mind, ensuring audit trails, electronic signatures, and data integrity requirements are automatically met.
Our AI models undergo rigorous validation processes to meet regulatory standards, providing intelligent automation you can trust in regulated environments.
Accelerate study startup, streamline site management, and ensure regulatory submission readiness with purpose-built clinical trial workflows.
Biotech is uniquely penalized by the failings of generic tools. A missed dependency is not just a delay; it's a multi-million-dollar setback that can derail entire clinical trials.
Critical workflows like Study Startup and CAPA are managed in siloed spreadsheets, creating massive inefficiencies and audit risks that compromise compliance.
Your CTMS, eTMF, and QMS don't talk to each other, making it impossible to see how a delay in one area impacts the entire regulatory submission timeline.
SME leaders are crushed between executive pressure for speed and QA pressure for perfection, with no tools to help them balance both requirements effectively.
Project Path is not just compliant; it actively facilitates your compliance through intelligent automation, validated workflows, and built-in regulatory safeguards.
We turn the black box of AI into a trusted, transparent tool for regulated work. Our "Corrective RAG" architecture produces auditable, cited outputs, dramatically reducing hallucination and creating audit-ready evidence packs.
Our platform is engineered from the ground up to enforce Good Clinical, Manufacturing, and Documentation Practices. We provide a fully compliant suite for electronic records and signatures, including immutable, timestamped audit trails.
We follow GAMP 5 and provide a comprehensive "Validation Accelerator Pack" with our URS, FS/DS, and executed IQ/OQ test scripts, dramatically reducing your internal validation effort from months to weeks.
We bring unprecedented structure, automation, and provability to your most critical processes, transforming how you manage clinical trials and regulatory submissions.
Transform this notorious bottleneck. Our Arc template automates the entire process from protocol to first patient enrollment, with AI agents flagging sites that are falling behind schedule.
Turn a compliance risk into a streamlined process. A QMS trigger automatically creates a CAPA project, pulls relevant documents, and auto-generates a complete, audit-ready evidence pack upon closure.
Orchestrate the complex narrative of your NDA/BLA submission. The Work Graph maps every dependency between clinical data, CMC documentation, and preclinical reports, giving you predictive insight into your timeline.
Manage tech transfer, scale-up activities, and change control with validated workflows that connect directly to your ERP and QMS, ensuring end-to-end data integrity.
Stop managing by spreadsheet. Give your team the intelligent system they need to accelerate life-saving therapies while maintaining the highest standards of compliance and quality.