We spent our careers building the MLM systems pharma companies, CROs and regulators actually rely on. LitSafe is what we'd build if we started over today.
Before LitSafe, we created the previous market-leading medical literature monitoring system. From the original Pi2 platform through its evolution under ProQuest, Dialog Solutions and later Clarivate, we built it, implemented it, migrated global pharmaceutical organisations onto it, and supported it through audits, inspections and day-to-day operational use.
That experience taught us something important. We saw first-hand where legacy MLM systems excelled and where they struggled. We watched platforms become harder to maintain, harder to validate, and harder to adapt as regulatory expectations, literature volumes, and operational demands continued to grow.
LitSafe is what we built to fix that. Everything we learned running the last generation of MLM platforms went into this one.
"Audits, CAPAs, and inspections reveal the true strengths and weaknesses of a system. Having supported organisations through each of them, we designed LitSafe around the qualities that matter most: control, traceability, transparency, and resilience under scrutiny." — LitSafe Founding Team
60+ years combined in medical literature monitoring, including five years leading Embase at Elsevier, and more than 9 million literature assessments processed across four prior generations of MLM platforms.
LitSafe is a workflow platform built for how pharmacovigilance teams actually operate, with validation and inspection readiness included, not bolted on.
URS, FRS, risk assessments, traceability, automated test execution, AI evaluation, model governance, and controlled change management. Built around QA and CSV expectations from the start, not retrofitted to meet them later.
Source ingestion, model versions, reviewer actions, overrides, annotations and approvals are captured in a complete audit trail with identity, timestamp, and rationale. Exportable on demand to support audits, inspections and customer QA review.
Drug synonyms, source sets, triage thresholds, reviewer workflows, QC sampling, and annotation layers are all configurable through controlled change processes, with full traceability and documented change records.
Built to handle tens of thousands of articles per drug, per year, intelligently deduplicated, so human reviewers spend their time on the key articles for drug safety reporting. Recall, traceability and oversight don't get traded away to get there.
Auditor findings are rarely surprising. More often, they stem from familiar weaknesses: search strategies that cannot be fully justified, gaps in source coverage, Day Zero processes that are not consistently controlled and audit trails that fail to provide the necessary evidence under scrutiny. LitSafe has been designed to address these challenges from the outset.
Every change to drug terms, synonyms, source coverage and exclusions is versioned, attributed and time-stamped, so any historical search can be recreated exactly as it ran, with a complete record of the decisions behind it.
Every product is mapped to its authorised markets against GVP's monitoring requirements. Gaps surface before an inspector finds them, and every required search leaves dated, attributable proof it happened.
Day Zero tracked with precision. Every literature-sourced case is anchored to the first documented availability of the publication to the MAH, monitored against reporting obligations and proactively escalated before a compliance risk emerges.
Evidence that survives scrutiny. Every search execution, screening decision, exclusion rationale, QC review, and approval is recorded with attributable electronic signatures, timestamps and complete audit history. Immutable, reproducible, and available on demand for audit and inspection review.
LitSafe wasn't created by AI specialists entering pharmacovigilance. Its founders have spent decades building, delivering, and operating medical literature monitoring systems, regulated platforms, and pharmacovigilance workflows for some of the world's most demanding pharmaceutical organisations.
Michael has spent more than two decades building and scaling information products used across life sciences.
His career spans Elsevier, Quosa, ProQuest Dialog, and Clarivate, including commercial leadership of the world's most-used biomedical literature database and multiple generations of medical literature monitoring technology.
He understands how pharmaceutical organisations evaluate, procure, and deploy regulated platforms at global scale.
Mark has been building and running medical literature monitoring operations for over 20 years.
Founder of Pi2 and a key figure across multiple generations of MLM technology, he has spent more than 20 years designing MLM workflows, leading implementations, and migrating major pharmaceutical organisations onto regulated literature monitoring platforms.
His experience spans operational pharmacovigilance, validation, inspection readiness, and the realities of running MLM programmes at scale.
David helped build the technology behind multiple generations of MLM platforms, from Pi2 through Dialog Solutions, Clarivate and the Drug Safety Triager.
He leads LitSafe's engineering team, responsible for both the AI models and the infrastructure they run on.
His focus is building systems that remain performant, traceable, and maintainable under real-world regulatory and operational pressures.
We spent years building, implementing, and supporting MLM platforms at scale. That experience showed us where even successful systems begin to bend under operational pressure, validation demands and regulatory scrutiny. LitSafe has been engineered to remove those compromises. Not to repaint them.
Medical literature monitoring (MLM) software automates the systematic review of published scientific literature for potential adverse drug reactions and safety signals. Under GVP Module VI, Marketing Authorisation Holders are required to conduct weekly searches of key databases including Embase and PubMed, and process any identified cases within 15 or 90 days. LitSafe provides a validated, audit-trailed platform to manage this workflow end to end.
LitSafe is built around GVP Module VI requirements: configurable source coverage mapped to each authorised market, versioned search strategies with timestamped change records, Day Zero tracking anchored at first MAH availability, and a full reviewer audit trail with attributable electronic approvals. Every required cadence produces dated proof-of-search.
Yes. LitSafe is designed with full Computer System Validation in mind, including a URS, FRS, risk assessment, traceability matrix, automated test execution, AI model governance, and controlled change management. The validation documentation is designed to be signed by a QA Director without modification.
LitSafe was built by the founding team behind Drug Safety Triager (Clarivate), Dialog Solutions (ProQuest), and Pi2. The three founders have over 60 years of combined experience in medical literature monitoring, pharmacovigilance platforms, and regulated software delivery into global pharma organisations.
Legacy MLM platforms were built as search engines with workflows bolted on. LitSafe is an AI-native regulated workflow platform designed from the ground up for inspection readiness: versioned search strategies, explicit source coverage statements per product and market, attributable audit trails, and configurable workflows owned by the customer's QA team rather than buried in service contracts.
If you're evaluating MLM platforms or planning a migration, get in touch.
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