Assure layer · Module 07Assure, RBQM & Safety
Quality and safety, continuous by design.
Assure is the quality and safety layer of ECS®, Risk-Based Quality Management, central monitoring and safety signal detection woven into the operating fabric. ICH E6(R3) makes RBQM the default; ECS® makes it live. Critical-to-quality factors, KRIs and QTLs are defined at study build and monitored continuously across every module.
Purpose-built, module by module.
Key Risk Indicators and Quality Tolerance Limits defined at study build, monitored live, with thresholds triggering reviewer workflows.
Off-site data review across sites, participants and visits, outliers, duplicate patterns and protocol drift surfaced automatically.
Site risk scores driven by data quality, enrolment quality, query aging and protocol deviations, targets on-site monitoring where it matters.
Structured adverse event reporting from participant (LucaH), site (ViSA) and clinician (Televisit), coded with MedDRA at source or centrally.
Aggregate signal analytics across AEs, ePROs and wearables, explainable AI proposes signals for human adjudication.
Structured E2B(R3) messages submitted to Eudravigilance, FDA FAERS and sponsor safety databases, inside the audit trail.
AI-drafted safety narratives signed by medical; DMC workspaces (blinded/unblinded); continuous eTMF and evidence packs by inspector question.
Deviations detected, classified (major/minor) and assessed for impact on subject safety and data integrity, auto-linked to critical-to-quality factors.
Regulatory & standards frame.
The regulatory and standards backdrop this module is designed against.
Risk-proportionate quality management, critical-to-quality factors and continuous oversight, built in from the first protocol draft.
Quality-by-design, CtQ factors defined at protocol and tracked throughout conduct.
AE/SAE definitions and structured E2B(R3) messages for regulatory safety reporting.
Aligned to industry RBQM framework, KRIs, QTLs and central monitoring.
Expedited reporting workflows for suspected unexpected serious adverse reactions (SUSARs).
E2B(R3) submission gateway for European post-authorisation and clinical trial safety reporting.
GxP-grade audit trail for safety records, signal reviews and adjudications.
Built to be handed to a regulator, with regional data residency in the sponsor's jurisdiction.
The rest of ECS®.
Trace every result, from capture to report.
Every action is dated, attributed and documented. We'll show you how the data trail works.