Functional Advisory

We provide comprehensive advisory to establish and enhance ICSR processing operations through end-to-end SOP development that covers the full case lifecycle—from intake to regulatory submission. Our support includes safety database configuration, encompassing business rules, data mapping, narrative templates, coding standards, and validation planning. We help define clear roles and responsibilities through tailored RACI frameworks and optimize workflows with intelligent case routing and equitable workload distribution models. Additionally, we guide clients in identifying high-impact automation opportunities using AI, NLP, and RPA to drive efficiency and scalability

We support the development of core signal detection and management workflows, clearly defining roles, timelines, and coordination points across pharmacovigilance functions. Our advisory includes fine-tuning statistical detection parameters such as PRR, ROR, and EBGM, as well as guiding the setup and customization of signal detection tools to align with organizational needs. Additionally, we help integrate diverse data sources—both structured and unstructured—into the signal detection framework to enhance signal quality and coverage.

We offer standardized templates and flexible clause libraries to streamline the drafting of Safety Data Exchange Agreements (SDEAs). Our guidance includes selecting and enhancing centralized platforms to effectively manage the full SDEA lifecycle —from creation through execution and renewal. We also assist in implementing AI-driven solutions for intelligent clause extraction, classification, and comparison across agreements. Additionally, we provide strategic support to integrate SDEA management tools with safety databases such as Argus, ARISg, or LSMV to ensure seamless operational alignment.

We assist in designing a systematic approach to track and evaluate global regulatory developments impacting pharmacovigilance. This includes mapping the current regulatory landscape specific to the client's products and markets, and analysing how new or updated regulations may affect internal processes, systems, and compliance obligations.

We design PV governance frameworks with clear roles, escalation paths, and oversight metrics, author governance charters for safety leadership, and ensure ongoing PSMF maintenance aligned with inspection readiness.