Delivery Services
Delivery Services That Drive Transformation and Power
Pharmacovigilance Excellence
Strategic leadership across the entire PV transformation journey
Our program management consultants are experienced domain experts with multiple successful implementations globally. Ascendura program and project management consultants ensure stakeholder alignment, proactive risk management, and disciplined execution using industry-recognized frameworks (PMP®, Agile, Hybrid), with a focus on compliance-driven delivery and measurable business impact.
Streamlining operations and enabling adoption across global safety functions
Successful PV system transformation depends as much on people and process as it does on technology. We help you standardize safety workflows across regions, products, and affiliates while enabling structured Organizational Change Management (OCM) — through impact assessments, communication planning, training design, and stakeholder engagement. Led by respected industry experts, our approach promotes smooth adoption, regulatory clarity, and operational stability.
Tailored setup of safety platforms to match your compliance and operational needs
Whether implementing Argus Safety, Veeva Vault Safety, ArisG LSMV, or signal management platforms - Oracle Empirica Signal or Qinecsa's Quantitative Signal Detection Services – our expert consultants configure systems backed by years of experience and best practices - to reflect your organization's unique case processing, signal review, and reporting needs. From business rules setup to workflow mapping and custom fields, we ensure every configuration is purpose-built for regulatory accuracy, user experience, and audit traceability.
Data Migration
We offer structured, high-integrity data migration services to transition historical and active data between platforms like Argus, ArisG, LSMV and Veeva Safety. Our expert consultants implement proven methodologies and custom built accelerators for data mapping, transformation, validation, and reconciliation, ensuring compliance with GxP and maintaining data integrity of critical safety information.
Risk-based validation for GxP-regulated safety systems
Our experienced consultants bring deep expertise in safety systems validation, leveraging proven methodologies for Computer System Validation (CSV) fully aligned with regulatory expectations and GxP guidelines. We support the full validation lifecycle — from planning and execution to audit readiness — ensuring every deliverable meets compliance and quality standards. Using either Ascendura’s qualified QMS or your organization’s existing QMS framework, we deliver comprehensive documentation including:
- Validation Plans
- User and Functional Requirements
- Traceability Matrices
- IQ/OQ/PQ Protocols and Test Scripts
- Validation Summary Reports
- Change Control and Periodic Review Support
Whether your PV systems are deployed on-premise or via SaaS, we ensure they are fully validated, secure, and inspection-ready — enabling compliance with confidence.
Embedding quality across the PV systems lifecycle
Our IT Quality & Compliance services provide robust IT quality frameworks tailored to safety system environments, including SOP design, periodic review processes, vendor audit support, and deviation/CAPA management. Our compliance consulting services ensure alignment with 21 CFR Part 11, GAMP5, GDPR, and other global regulations, helping you maintain operational integrity and withstand regulatory scrutiny.
Driving strategy, roadmap, and business alignment for innovative safety solutions
Our product managers work with internal business, IT, and regulatory stakeholders to define and evolve your safety system strategy — ensuring each release or upgrade reflects user needs, regulatory shifts, and operational goals. We bring expertise in backlog prioritization, stakeholder alignment, release planning, and metrics-driven optimization for PV and signal detection platforms.
Technical depth to support custom solutions, integrations, and optimizations
Our engineering teams bring hands-on expertise in designing and integrating PV and signal management systems with upstream and downstream tools — including E2B Gateways, CTMS, EDC, and regulatory databases. We support custom development, API integrations, performance tuning, and interface validation, ensuring your safety ecosystem is seamless, secure, and scalable.
