Qlarix, a pioneer in clinical trial innovation, today announced the official launch of WiseCLIN, a purpose-built Risk-Based Quality Management platform designed specifically for biopharmaceutical sponsors, Clinical Research Organizations (CROs), medical device companies, and research entities.
In today’s increasingly complex clinical trial environment, managing regulatory compliance, including Good Clinical Practice (GCP) and evolving standards like ICH E6(R3) and ICH E8(R1), presents major operational hurdles. Traditionally, Risk-Based Quality Management (RBQM) activities are scattered across disconnected spreadsheets, emails, meeting minutes, and isolated software. This fragmentation makes maintaining consistency, data integrity, and audit-ready oversight nearly impossible.
WiseCLIN solves this challenge by delivering a single source of truth that connects Critical-to-Quality (CtQ) factors, study risks, risk controls, Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), risk review cycles, and oversight decisions within one fully traceable workflow.
As a comprehensive WiseCLIN RBQM software solution, the platform helps clinical trial teams reduce trial risks by 30% or more while cutting overall study costs by up to 20%.
Key Capabilities of the WiseCLIN Platform
- End-to-End RBQM Traceability: Seamlessly links CtQ factors, study risks, controls, KRIs, QTLs, and oversight decisions across the entire study lifecycle.
- Dynamic Risk Management Boards: Adaptable risk tracking tailored to the specific complexity, phase, and therapeutic area of each trial.
- Centralized Real-Time Oversight: Customizable dashboards track quality metrics, vendor performance, and protocol deviations in real time, simplifying audit readiness.
- Built for Evolving Regulations: Purpose-built to help organizations effortlessly meet global standards, including ICH E6(R3), ICH E8(R1), and ICH Q9.
- Integration-Friendly Architecture: Designed to connect smoothly with existing eClinical ecosystems, including CTMS, eTMF, EDC, and other trial systems.
Whether supporting biopharmaceutical sponsors managing global portfolios, CROs delivering transparent oversight to partners, or medical device teams generating clinical evidence, WiseCLIN accelerates study timelines while maintaining rigorous compliance. In addition to software implementation, Qlarix provides tailored training and expert consulting to help organizations achieve full RBQM maturity.
About Qlarix
Qlarix empowers life sciences organizations to embrace Risk-Based Quality Management (RBQM) and redefine the future of clinical trials. By merging deep research expertise with innovative technology like WiseCLIN, Qlarix translates a proactive culture of risk to clinical research. Its mission is to deliver cutting-edge technology and consulting that elevate trial efficiency, maintain audit-ready oversight, and safeguard data integrity. Qlarix strives to be the preferred global partner advancing healthcare outcomes through reliable, compliant, and modernized clinical research.
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