Do you have authorization to conduct a clinical trial with your investigational drug? Do you know that you should evaluate the safety data and analyse the emerging risks during trials? During the clinical development of
Read MoreIn the European Union (EU), rare diseases contribute to approximately 6-8% of total deaths across all age groups. The death percentage is about 35% among the pediatric population, especially in the first year of life,
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Pharmacovigilance 2026 is set to be a definitive platform for patient safety, featuring strengthened and automated vigilance systems. The future of Pharmacovigilance is poised for a transformative shift, driven by new avenues such as automation
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An Asia-based mid-sized pharmaceutical company sought to launch a generic anti-hypertensive drug in the U.S. market. With limited internal expertise in FDA submissions and facing a tight launch timeline, the client needed end-to-end support for
Read MoreA global medical device manufacturer needed to expand into multiple new markets across Europe, Middle East, and Asia-Pacific (EMEA & APAC). The challenge was to achieve quick and compliant registration of Class II and III
Read MoreA Top 10 Global Biopharmaceutical Company faced increasing regulatory scrutiny and needed to strengthen its Pharmacovigilance (PV) quality systems worldwide. The project included 15+ global PV audits across 9 months, addressing inconsistent PV practices across
Read MoreA mid-sized U.S.-based pharmaceutical company approached Vigilare to rapidly implement a global safety database within an aggressive four-week timeline. The scope involved migrating 4,000+ legacy safety cases (some over 20 years old), supporting 4 affiliate
Read MoreThe Importance of Vendor Audits: Ensuring Compliance and Quality Across Industries In today’s complex business environment, vendor audits play a critical role in maintaining quality, regulatory compliance, and operational integrity. Whether in healthcare, manufacturing, technology,
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TGA Seeks Feedback to Modernize Clinical Trial & Pharmacovigilance Australia’s Therapeutic Goods Administration (TGA) is revising its clinical trial and pharmacovigilance guidelines to align with global benchmarks—a move poised to reshape research and drug safety practices.
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As clinical research advances in complexity and innovation, the urgency for diversity, equity, and inclusion (DEI) in trials has never been more critical. Beyond regulatory compliance or industry buzzwords, DEI in clinical trials is about
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