.webp)
Stop chasing paper and screenshots - start proving source integrity
Remote Source Data Verification (rSDV) reduces monitor travel while making sure that regulated evidence is stronger: which source document is being verified, which eCRF data point it belongs to,who reviewed it remotely, and when the verification was locked.
rSDV helps sponsors, CROs, and clinical teams keep verifying standard source data at a large scale without having to go to the site. When sites upload source documents or enter eCRF data, rSDV immediately lets monitors view, verify, and question data remotely. This cuts down on travel costs and makes it easier to keep track of compliance across sites and research. It's designed to make standard monitoring remote: upload, check, verify, and show proof.
- •Assignments for remote verification based on roles and controls for regional monitoring.
- •Controlled source/eCRF traceability with logs of verification timestamps and reviewer signatures.
- •Proof of verification and annotated source snapshots suitable for audits and regulators.
rSDV Features
Intelligent source mapping, remote verification workflows, and audit-grade traceability designed for regulated clinical monitoring.
Automatic Source-to-eCRF Mapping
Auto-identify and map source values to corresponding eCRF fields using metadata and OCR to reduce manual lookup and errors.
Secure Remote Access & Read-Only Provenance
Provide permissioned, time-limited access to source documents, images, and system logs with immutable provenance and view-only controls.
Real-Time Discrepancy Detection & Flagging
Detect mismatches between source and eCRF values instantly and surface high-priority discrepancies for focused review.
Annotated Source Viewer & Verification Notes
Mark, annotate, and timestamp source evidence inline; capture reviewer notes and verification rationale for audit trails.
eCRF Reconciliation & Auto-Query Generation
Automate reconciliation flows and convert discrepancies into routed queries with root-cause tags, ownership, and closure evidence.
Risk-Based Prioritization & Monitoring Workflows
Prioritize remote SDV by risk signals—enrollment trends, safety flags, or protocol deviations—to focus effort where it matters most.
Resolution Tracking & Escalation Rules
Track query lifecycle, escalations, and resolution timestamps with time-stamped proof for sponsors and auditors.
Integration & Data Flow
Bi-directional connectors for EDC, CTMS, eTMF, safety systems, and vendor tools so verification evidence stays synchronized without manual reconciliation.
Compliance,
Security &
Validation Readiness
Built for regulated life sciences workflows with role-based access, secure audit trails, and electronic record controls designed to support GxP requirements and inspection expectations. We combine strong controls (roles, permissions, audit trails, Data integrity) with AI-assisted automation that reduces manual effort while keeping evidence complete.
- •Audit trail, traceability, and evidence-first workflows to support your validation/assurance approach (URS → risk → security test evidence).
- •Access control, segregation of duties, and configurable permissions.
- •Configurable workflows to match your SOPs and quality system.
Want to accelerate your rollout? We can provide a validation-ready evidence framework aligned to your SOPs.
rSDV Use Cases
Designed for remote monitoring scale-up, RBM execution, source/eCRF reconciliation, and inspection-ready verification.
Remote Monitoring & Travel Reduction
Enable monitors to verify source remotely while reducing on-site visits and focusing on high-risk issues.
Source-to-eCRF Reconciliation
Automate mapping and reconciliation to cut query cycles and ensure data provenance for locked datasets.
Safety Signal Verification
Quickly verify source records tied to SAEs and safety signals with time-stamped evidence and reviewer notes.
Targeted RBM Execution
Prioritize verification tasks by risk tiers and document remediation with full audit trails.
eTMF & Monitoring Evidence Bundles
Bundle annotated verification snapshots, queries, and resolution logs into inspection-ready exports.
Vendor & Site Collaboration
Standardize source submission formats, control access, and streamline verification across external partners.
Frequently Asked Questions About rSDV
A CTMS manages trial operations (site activation, monitoring workflows) while an EDC captures CRF data; rSDV bridges source verification between site records and EDC for audit-ready data integrity.
rSDV respects protocol/visit versions by linking verification tasks to the controlling protocol and visit schedule, ensuring correct source context after amendments.
Auditors expect time-stamped verification logs, annotated source snapshots, reconciliation records, and query resolution trails—rSDV captures all as inspection-ready evidence.
Yes — rSDV supports bi-directional integration with EDC, safety/PV systems, eConsent, CTMS, and eTMF to keep verification evidence synchronized.
Yes — built for global trials with role-based access, regional controls, and centralized oversight across multiple sponsors, CROs, and sites.
Ready to Scale Remote Source Verification with Audit-Ready Evidence?
Get inspection-ready rSDV evidence, secure remote access, and real-time discrepancy visibility across your monitoring programs.