INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES
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![GettyImages-1468153601-regulation-honeycomb-hand-target]( "Understanding Decentralized Clinical Trials: FDA vs. EMA Fundamentals")
Understanding Decentralized Clinical Trials: FDA vs. EMA FundamentalsDesigning a global decentralized clinical trial requires understanding the differing FDA and EMA approaches to trial models and informed consent.
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![Pill capsule in doctors hand-GettyImages-922565512]( "Managing Drug And Data Requirements In Decentralized Clinical Trials")
Managing Drug And Data Requirements In Decentralized Clinical TrialsRunning a global decentralized clinical trial requires a deep understanding of the differences in FDA and EMA requirements for investigational products and patient data.
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![GettyImages-2172328990-5-five]( "5 Essential Steps To Implementing Decentralized Clinical Trials Globally")
5 Essential Steps To Implementing Decentralized Clinical Trials GloballyRunning a global decentralized clinical trial requires a strategy that balances the FDA's focus on technology accessibility with the EMA's emphasis on validation and comprehensive documentation.
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![GettyImages-1734850678 checklist]( "Best Biostatistics Practices To Drive Clinical Trial Success")
Best Biostatistics Practices To Drive Clinical Trial SuccessUtilize this checklist of best practices for biostatistics in clinical trials, from early planning to regulatory submission.
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The New Era Of Project Optimus: Implications for Oncology Development Strategy9/10/2025
In this presentation, expert speakers bring the impact of Project Optimus to life through real-world case studies and practical examples.
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Best Practices For Operationalizing Global, Early-Phase Oncology Trials9/10/2025
In this presentation, industry experts will share real-world lessons learned from managing global early-phase oncology trials.
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Navigating What's Next For Global Drug Development: What Sponsors Need To Know9/10/2025
Learn how new FDA initiatives and global regulatory changes can impact your strategy for 2025 and beyond.
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Exploring Ex-US Markets To Reduce Risk For Your Clinical Trials9/10/2025
How biotech and emerging pharma companies are increasingly leveraging regions such as APAC and Eastern Europe to accelerate trial start-up, secure high-quality data, and optimize costs.
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GLP-1 Ocular Safety Monitoring At Point-Of-Need9/8/2025
Regulators are sharpening their focus on ocular safety in GLP-1 receptor agonist trials following emerging evidence linking semaglutide to non-arteritic anterior ischemic optic neuropathy (NAION).
CLINICAL TRIAL REGULATORY SOLUTIONS
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![GettyImages-2054515915-computer-files-keyboard-digital]( "Regulatory Strategy And Submission Support")
This Regulatory Operations Team enables biotech and pharmaceutical companies to focus on innovation while ensuring a smooth, compliant path to market entry.
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![rules, policies, regulatory documents-GettyImages-1438925546]( "Regulatory Strategy And Submission Support")
Eliminate delays and ensure seamless regulatory alignment with an experienced toxicology services team.
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![GettyImages-1025834378-manufacturing-excipient-drug-pharma]( "Accelerate Your Drug Development With A Global Partner")
With the right Chemistry, Manufacturing & Controls (CMC) consulting services, your organization can excel in early-stage strategizing, accelerate timelines, optimize processes, and reduce costs.
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![GettyImages-1180547358-computer-research]( "Life-Changing Therapies Without A Lifetime Of Development")
Learn about this integrated suite of services that spans global CRO capabilities, central laboratory services, and IVD & CDx regulatory development consulting.
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![GettyImages-2189597043-production-facility-laptop-software]( "Pharmacovigilance Quality Assurance & Inspection Readiness")
Whether preparing for a product launch or entering a new market, we ensure your safety systems are compliant, efficient, and built to withstand regulatory scrutiny.
REGULATORY MULTIMEDIA
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![The New Era Of Project Optimus]( "The New Era Of Project Optimus: Implications for Oncology Development Strategy")
The New Era Of Project Optimus: Implications for Oncology Development StrategyIn this presentation, expert speakers bring the impact of Project Optimus to life through real-world case studies and practical examples.
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![Best Practices For Operationalizing Global, Early-Phase Oncology Trials]( "Best Practices For Operationalizing Global, Early-Phase Oncology Trials")
Best Practices For Operationalizing Global, Early-Phase Oncology TrialsIn this presentation, industry experts will share real-world lessons learned from managing global early-phase oncology trials.
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![GettyImages-1783586499 regulatory compliance]( "Navigating What's Next For Global Drug Development: What Sponsors Need To Know")
Navigating What's Next For Global Drug Development: What Sponsors Need To KnowLearn how new FDA initiatives and global regulatory changes can impact your strategy for 2025 and beyond.
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![GettyImages-2167764241-Europe-european-map]( "Exploring Ex-US Markets To Reduce Risk For Your Clinical Trials")
Exploring Ex-US Markets To Reduce Risk For Your Clinical TrialsHow biotech and emerging pharma companies are increasingly leveraging regions such as APAC and Eastern Europe to accelerate trial start-up, secure high-quality data, and optimize costs.
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![Prioritizing Safety in Clinical Trials The Impact of Culture on Operational Success]( "Prioritizing Safety In Clinical Trials")
Prioritizing Safety In Clinical TrialsThis presentation explores organizational culture and the values that are essential to delivering high-quality safety oversight.
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![Cencora - oncology webinar]( "Navigating The Regulatory Complexities Of Targeted Medicines In Oncology")
Navigating The Regulatory Complexities Of Targeted Medicines In OncologyExplore the strategic considerations for successfully navigating the regulatory complexities of targeted medicines. Learn about the challenges in translational medicine and key clinical development considerations.
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![Cencora - Summer Shorts - Thinking Ahead]( "Thinking Ahead: How Integrated Development Plans Improve Product Success")
Thinking Ahead: How Integrated Development Plans Improve Product SuccessHow can integrated development planning reduce development timelines and increase your chances of commercialization success? Industry experts reveal how this approach helps avoid common pitfalls.
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![Cencora - Shaila Yoshida]( "Understanding The Evolving Landscape Of Anti-Obesity Medication (AOMs)")
Understanding The Evolving Landscape Of Anti-Obesity Medication (AOMs)Discover the evolving landscape of AOMs as a value and access expert shares the latest payer coverage trends, concerns, and strategies. Learn how payers are making critical coverage decisions.
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![GettyImages-1551861554-FDA]( "The 3 FDA Oncology Approvals That Will Have The Biggest Impact In 2025")
The 3 FDA Oncology Approvals That Will Have The Biggest Impact In 2025The FDA wrapped up 2024 with 3 notable approvals. Harpreet Singh, MD and CMO, provides a recap.
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![FDA Headquarters-GettyImages-1286971245]( "The FDA's New Guidance May Be Shaking Up Biotech")
The FDA's New Guidance May Be Shaking Up BiotechThe FDA’s recent draft guidance on accelerated approval outlines tougher standards for confirmatory trials and introduces a faster process for withdrawing approvals.
