We combine clinical expertise with intelligent technology to simplify safety workflows, to make safer, data‑driven decisions.
DhatuSafety is a modern pharmacovigilance platform designed to help life sciences organizations manage safety data with clarity, control, and regulatory confidence.
It is built from the ground up to align with global pharmacovigilance quality expectations.
Shaped by real pharmacovigilance workflows supporting sponsors, CROs, multi-region environments.
Optimize how cases are collected, processed, reviewed, and submitted with an intelligent and guided workflow.
Multi-source intakeTriage and prioritizationNew case creationCase Linking
Case data managementMedical coding (MedDRA)Seriousness, causalityFollow-UpsE2B (R3), CIOMS, PDFsAggregate reports (PSUR)New case creationFollow‑Up ReportingSignal detectionCompliance monitoringAudit trailsPortfolio Oversight Multi-source intake Triage and prioritization New case creation Case Linking Case data managementMedical coding (MedDRA)Seriousness, causalityFollow-UpsE2B (R3), CIOMS, PDFsAggregate reports (PSUR)New case creationFollow‑Up ReportingSignal detectionCompliance monitoringAudit trailsPortfolio OversightTransform safety data into clinically sound, regulator-ready decisions through structured review and coding.
Safety data is collected from emails, portals, call centers.
Create clear, regulator ready narratives using standardized, version.
Map assessments to RSI, guided by the Investigator’s Brochure.
Ensure medical sign-off through defined review and approval workflows.
Safety data is collected from emails, portals, call centers.
Create clear, regulator ready narratives using standardized, version.
Map assessments to RSI, guided by the Investigator’s Brochure.
Ensure medical sign-off through defined review and approval workflows.
Use to streamline safety data capture, case processing, and literature surveillance during trials.
Accelerate coding with intelligent suggestions while preserving medical oversight.
Track every coding decision, change, and approval with a complete, end‑to‑end audit trail.
Proactively identify, assess, and monitor safety risks with full visibility, traceability, and operational control.
Continuously identify potential safety signals across cases, reports, and data trends, and prioritize them based on clinical relevance, impact, and regulatory risk.
Maintain structured documentation for every stage of the signal lifecycle from detection and evaluation to decision and closure ensuring audit readiness.
Establish direct traceability between signals, individual cases, and aggregate reports, enabling consistent evaluations and evidence-based decision making.
Track timelines, workload, and compliance metrics against defined SLAs, with early visibility into risks, delays, and regulatory commitments.
Streamline global safety reporting with built-in validation, monitoring, and traceability.
Generate regulator-ready safety reports with full compliance and speed. The platform supports E2B (R3) compliant case generation, including initial, follow-up with built-in validation to ensure data completeness.
Manage periodic safety reports through structured, end-to-end workflows. DhatuSafety supports PSUR, PBRER, and DSUR preparation, including line listings and cumulative summaries.
Maintain full visibility and control over regulatory submissions. The platform continuously tracks gateway acknowledgements, supports error handling and automated retries, and performs submission readiness.
