AI-powered regulatory intelligence for clinical research
Logic Line combines advanced AI analysis with deep regulatory knowledge to help sponsors, CROs, and quality teams navigate inspections, SOPs, and compliance — faster and with greater confidence.
A Dileas CS Ltd product
What is Logic Line?
Logic Line is an AI software platform built specifically for the clinical research and regulatory environment. It retrieves, analyses, and interprets regulatory guidance — then delivers structured, cited answers your team can act on. Whether you're preparing for an inspection, reviewing SOPs for gaps, or navigating complex regulatory questions, Logic Line gives you a trusted, intelligent starting point.
Core capabilities
Four modules. One intelligent platform.
Logic Line is built around four integrated intelligence modules, each designed for the realities of clinical and regulatory work.
AI analysis & regulatory retrieval
Logic Line queries a curated regulatory knowledge base — including guidance documents, frameworks, and source files — and returns precise, contextually relevant answers with structured source citations and answer-status metadata so you always know the confidence and provenance of every response.
Inspection intelligence
Prepare for regulatory inspections with confidence. Logic Line analyses inspection-relevant queries against current regulatory expectations, flagging areas of risk and surfacing the guidance that matters most to inspectors.
SOP & gap-review logic
Upload your SOPs and let Logic Line identify gaps against current regulatory requirements. The platform maps your procedures to the relevant guidance, highlights discrepancies, and generates a structured gap report — saving days of manual review.
Client-facing interface & quick actions
A clean, intuitive interface designed for regulatory professionals. Quick actions surface the most common workflows instantly, while privacy-conscious activity logging keeps your team's interactions auditable and secure.
Built with guardrails
Responsible AI for high-stakes environments
Logic Line is designed for high-stakes regulatory environments. Every response is governed by a layered guardrail system.
Medical guardrails
Responses involving clinical or medical content are scoped and flagged appropriately.
Legal & certification guardrails
Legal and certification-related queries are handled with appropriate caveats and escalation prompts.
Unsupported-answer detection
When the system cannot provide a reliable answer, it says so — clearly and transparently.
Upload guardrails
Document uploads are validated and scoped to prevent misuse and protect data integrity.
HTTP guardrails
All external data retrieval is governed by strict HTTP-level controls and source validation.
Privacy-conscious logging
Activity logging is designed with privacy in mind — capturing what's needed for audit without exposing sensitive user data.
Quality you can rely on
Validated. Tested. Audit-ready.
Logic Line is built to the same quality standards we apply to clinical data management.
Backend automated tests
A comprehensive automated test suite validates every core function of the platform, ensuring reliability and catching regressions before they reach users.
Phase 3 manual UAT
Logic Line undergoes structured manual user acceptance testing before each release, with a formal UAT checklist covering all key workflows and edge cases.
Regulatory knowledge base
The platform is powered by curated regulatory source files and a generated search index — kept current with evolving guidance from ICH, FDA, EMA, and other key bodies.
A Dileas CS Ltd product
Logic Line is developed and supported by the same team behind our clinical data management services — built to the same standards of quality and compliance.
Important notice regarding AI-assisted outputs
Logic Line is an AI-assisted tool designed to support, not replace, qualified data management professionals. All AI-generated outputs — including query suggestions, anomaly flags, and coding recommendations — should be reviewed and validated by a trained data manager before use in regulated submissions or clinical trial documentation. Dileas CS Ltd does not accept liability for decisions made solely on the basis of AI-generated outputs without appropriate human oversight and verification.
Ready to see Logic Line in action?
Request a demo and we'll show you how Logic Line can support your regulatory and quality workflows.