The team behind LitSafe has spent years developing and scaling systems trusted by global pharmaceutical companies, CROs and regulatory authorities. LitSafe brings that experience into a platform designed for the future of medical literature monitoring.
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 weren't just observers. 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 was created to solve these problems. It is the platform we are building bringing with us everything we have learned from decades of real-world MLM implementations, validation and operation. Designed from the ground up for modern pharmacovigilance teams, LitSafe combines the lessons of the past with the technology standards expected today.
"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
LitSafe is a workflow platform engineered for the realities of pharmacovigilance operations, validation and inspection readiness.
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.
Engineered to handle tens of thousands of articles per drug per year, intelligently removing duplication and focusing reviewer attention where it matters most. No compromise on recall, traceability, transparency or human oversight.
Auditor findings are rarely exotic. 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.
Search logic you can defend with confidence during an inspection. Every change to drug terms, synonyms, source coverage, and exclusions is fully versioned, attributed and time-stamped. Any historical search can be recreated exactly as it ran, with a complete record of the decisions behind it.
Coverage you can defend in an inspection. Every product is mapped to its authorised markets, with source coverage aligned to GVP monitoring requirements. Gaps are surfaced proactively and every required search produces dated, attributable proof-of-search.
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 is one of the industry's most experienced medical literature monitoring specialists.
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 platform architecture and engineering teams, combining deep domain knowledge with modern AI and cloud technologies.
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.
Whether you're evaluating new platforms, planning a migration, or preparing for growth, we'd welcome the conversation.