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At Galaxbiotech Solutions, we believe pharmacovigilance should go beyond compliance—it should empower informed, timely decision-making. Our team—comprising experienced safety physicians, PV scientists, and data specialists—manages the entire safety data lifecycle, from case intake and coding to signal detection, aggregate reporting, and regulatory submissions.
Powered by Tarra Pharmacovigilance and integrated with LUP Analytics, we streamline safety workflows, ensure standardized assessments, and deliver real-time insights into emerging risks. Every process adheres to global standards (ICH, GVP, FDA, EMA, and local regulations), supported by documented procedures, validations, and audit trails—so you’re always inspection-ready, at every stage of the product lifecycle.
We start by assessing your product portfolio, risk profile, and regulatory environment to design a customized pharmacovigilance (PV) system that fits your needs. This includes:
Our approach ensures that safety issues are identified, evaluated, and addressed efficiently, with clear documentation at every step. Through regular governance meetings and real-time dashboards, we provide senior stakeholders with full visibility into key metrics, inspection readiness, CAPAs, and ongoing commitments—across both clinical studies and post-marketing activities.
With Tarra, we centralize the collection of Individual Case Safety Reports (ICSRs) from all sources—clinical trials, spontaneous reports, literature, patient support programs, and partners. Using standardized intake templates, automated duplicate checks, and triage protocols, we ensure serious and high-priority cases are flagged without delay.
Our team handles the entire process—data entry, MedDRA/WHO-Drug coding, narrative preparation, and follow-up—within a structured, fully auditable workflow. E2B-compatible exports and seamless gateway integrations
Every case represents a patient’s experience—not just data. Our safety physicians and medical reviewers evaluate each case with clinical expertise, assessing seriousness, causality, expectedness, and clinical relevance.
We maintain consistent coding practices and rigorous quality reviews to ensure medical accuracy, which is essential for reliable downstream analysis. Using integrated signal detection tools in Tarra and LUP Analytics, we track trends across events, indications, dosages, age groups, and regions.
By combining statistical analysis with clinical insight, we distinguish true safety signals from background noise, enabling informed decisions about label updates, risk-minimization strategies, or further investigations.
Regulators require more than just case-level data—they need a comprehensive, evolving assessment of benefit–risk balance. We support the full lifecycle of periodic safety reporting, including PSURs, PBRERs, DSURs, and ad-hoc risk–benefit evaluations.
Our team prepares standardized data extracts, listings, and analyses that seamlessly integrate with medical writing. We deliver cumulative tabulations, exposure summaries, signal evaluations, and benefit–risk narratives, all fully traceable to source case data.
With version control, structured review workflows, and QC checklists embedded in the process, every report is consistent, defensible, and submitted on time to the appropriate authorities.
To ensure inspection readiness, we prioritize consistency and accuracy of safety information across all systems. We conduct regular reconciliations between clinical databases, safety systems, EDC, CTMS, and external sources, verifying alignment of AEs, SAEs, deaths, discontinuations, and pregnancies.
Any discrepancies are investigated, documented, and resolved with clear accountability. We track key quality metrics—such as overdue follow-ups, query turnaround times, coding consistency, and case completeness—through real-time dashboards. This proactive oversight minimizes audit surprises and reinforces confidence in your safety profile.
Safety data reaches its full potential when it is accessible, actionable, and insightfulb>. By integrating LUP Analytics with Tarra, we create interactive dashboards that display real-time PV KPIs, event trends, product comparisons, and geographic patterns.
Users can drill down from high-level insights to case-specific details, all while maintaining full traceability. We tailor views for different stakeholders—safety teams, clinical development, medical affairs, and senior management—so each group focuses on the metrics most relevant to their role.
These analytics not only ensure regulatory compliance but also drive strategic decisions—from labeling updates and risk-minimization strategies to future study designs.