INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES
-
![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.
-
![GettyImages-2157971431-new zealand]( "Why New Zealand Is Emerging As A Clinical Trial Hub")
Why New Zealand Is Emerging As A Clinical Trial HubNew Zealand is rapidly emerging as a premier destination for clinical research, offering a unique combination of regulatory agility, scientific expertise, and cost efficiency.
-
![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.
-
![GettyImages-692413188 lab research]( "Project Orbis Drug Registration 2025")
Project Orbis Drug Registration 2025Project Orbis helps streamline the review and approval of oncology medicinal products through international regulatory collaboration. Learn how this framework can accelerate your regulatory strategy.
-
Unlock Oncology Success With A Comprehensive Commercialization Guide8/22/2025
Navigate the complex process of bringing an oncology therapy to market, from regulatory planning to patient access and supply chain logistics, with this comprehensive handbook for developers.
-
Audit Trails And Transparency: Changes In Clinical Data8/18/2025
Audit trails are not only a regulatory necessity but a strategic tool to ensure data reliability and accelerate high-quality clinical research outcomes.
-
2025 Global Report For In-Vivo CAR Cell Therapy8/14/2025
Explore global trends shaping in-vivo CAR therapies—delivery innovations, clinical trial momentum, and regulatory strategies across oncology and autoimmune diseases.
-
LBPs: Unique Quality, Manufacturing, And Nonclinical Considerations8/14/2025
Live biotherapeutic products (LBPs) are emerging as a dynamic area of drug development, and their development demands tailored strategies that address both manufacturing and nonclinical complexities.
-
Understanding Immunogenicity In AAV Gene Therapy8/14/2025
As adeno-associated virus-based gene therapies progress toward clinical use, effectively managing immunogenicity risk is critical to patient selection, therapeutic durability, and regulatory success.
CLINICAL TRIAL REGULATORY SOLUTIONS
-
![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.
-
![rules, policies, regulatory documents-GettyImages-1438925546]( "Regulatory Strategy And Submission Support")
Eliminate delays and ensure seamless regulatory alignment with an experienced toxicology services team.
-
![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.
-
![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.
-
![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
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![GettyImages-505766677-team-meeting-collaboration-group-teamwork-discussion]( "All You Need To Know About 505(b)(2), But Were Afraid To Ask")
All You Need To Know About 505(b)(2), But Were Afraid To AskJoin us to explore the 505(b)(2) pathway. Learn how to bring improved drugs to market faster, reduce costs, and add value with this streamlined regulatory approach.
-
![rules, policies, regulatory documents-GettyImages-1438925546]( "Regulatory Advantages Of Clinical Trials In Canada Versus Australia")
Regulatory Advantages Of Clinical Trials In Canada Versus AustraliaAn expert answers your question about the regulatory advantages of conducting your clinical study in Canada versus Australia. Watch now to learn more.
-
![Drug Price Controls]( "Drug Price Controls: What Are The Unintended Consequences To Innovation?")
Drug Price Controls: What Are The Unintended Consequences To Innovation?Review the ripple effects of drug price controls, including recent U.S. policy shifts like the IRA and President Trump’s Executive Order introducing International Reference Pricing.
-
![450_300-screenshot_2025_07_21_084245]( "Controlling Comment Chaos: A Medical Writing Leader's Story")
Controlling Comment Chaos: A Medical Writing Leader's StoryDiscover how Sarah Wilson, Director at Alkermes, revolutionized document collaboration using a document review platform to boost efficiency and overcome regulatory challenges in medical writing.
