Global Regulatory-Aligned AI-Based Protocol Generation and Optimization Platform
AI-regulatory/clinical platform harmonizing requirements with competitive/regulatory/clinical/market access optimization for automated protocol authoring
Clinical trial protocol generation demands significant resources. Delays in protocol finalization can reduce the speed to market for life science companies.
FASE is an AI-first solution that transforms how Clinical and Medical teams generate and manage study protocols. This protocol generating platform includes access/ regulatory/ clinical/ competitive insights tools and is based on the largest curated database of clinical trials.
Protocols generated by FASE:
Comply with FDA, ICH, EU and local GCP frameworks
Generated in a few hours
Secured in enterprise-grade environment
In-built sample size estimations
Validation and consistency checks
Verified by regulatory and clinical experts
FASE provides access to comprehensive reference information in our patented system. The system includes integrated collaboration and citation tools.
Benefits Of FASE
Accelerated Protocol Cycles
Achieve over 90% reduction in protocol creation and amendment turnaround timesAlways Track Every Change
Maintain complete transparency with built-in version control and detailed audit logsCollaborate Without Barriers
Enable seamless and real-time coordination between internal and external stakeholders
Ready-To-Use Information Access and Management
Use integrated features that provide direct access to and management of all relevant information through CView (patent pending)Document Generation
Generate documents effortlessly using built-in content generation, revision, review and citation toolsSupport That Understands
Rely on responsive, expert assistance at every stage of your protocol workflow
Compliance-First Approach
Our clinical trial protocols are engineered for seamless regulatory acceptance across all major global jurisdictions — including the FDA (United States), EMA (European Union), MHRA (United Kingdom), Health Canada, PMDA (Japan), NMPA (China), TGA (Australia), Swissmedic (Switzerland), HSA (Singapore), CDSCO (India), and other national authorities.
We rigorously align every protocol with ICH-GCP E6(R3) and applicable regional regulations such as FDA 21 CFR Part 312, EU CTR 536/2014, and local GCP frameworks. This ensures our studies are ethically sound, inspection-ready, and globally compliant from the outset — supporting accelerated approvals, high-quality data generation, and patient safety across borders.
Use Cases of FASE
Phase I–IV clinical trials
Support every stage of clinical development—from first-in-human to post-marketing studies for life science companies, vendors and academic institutionsInvestigator-initiated studies
Empower individual researchers by doing the protocol generation work with full reliabilityExternal collaboration
Streamline and expedite protocol creation, revisions and reviews between sponsors, consultants and Contract Research Organizations (CROs)
Powering Efficiency with AI and Data
FASE is built on the industry’s largest custom-built database, designed to deliver secure, controlled, and highly reliable content. With over 35,000 clinical trials and other critical sources pre-processed into the B1 platform, FASE ensures unparalleled access to structured information.
Our patent pending CView technology enables rapid delivery of insights from this vast database, helping life science companies and their partners expedite protocol development.
FASE supports life science companies in overcoming operational bottlenecks. Our team of AI, data science, clinical, regulatory, and evidence experts engage at every stage to ensure that only accurate, validated content reaches the end user. This behind-the-scenes infrastructure is purpose-built for speed, accuracy, and compliance.
Whether you're a life sciences company or a strategic partner, FASE, along with our companion tool MDash, equips your teams with everything needed to drive success in a competitive market.
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