FDA scrutiny is intensifying. Strong SOPs, airtight IP accountability, and data integrity practices are now essential to protect trials, patients, and approvals.
- From Crisis Response To Repeatable Resilience In Clinical Supply
- Transitioning Into A Clinical Trial Supply Chain Study Lead Role
- U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact
- Beyond The AI Hype: Prompt Engineering In Clinical Trial Supply
- Active Versus Passive Shipping Solutions For Clinical Shipments
- Managing Risk And Resilience In Clinical Trial Supply And Operations
- FDA Staffing Constraints And Operational Risk In Clinical Supply
- Tariffs Threaten Clinical Trial Supply Chains: Preparing For Volatility
ON-DEMAND WEBINARS
Decentralized clinical trials are made up of a multitude of elements, from in home clinical capabilities, logistics, digital platforms, and technology, to global reach and more. This webinar shares important factors to consider to build your DCT ‘molecule’ successfully.
This webinar demystifies the term “agile,” from an operational perspective, while highlighting the speed and flexibility these systems offer to be able to support complex protocols that require accelerated changes.
This webinar discusses the types of master protocols and how configurable, modern RTSM systems enable fast and seamless mid-study changes to help you efficiently run your master protocol study.
Experts take you through the entire selection process for primary packaging components for lyophilization and provide aspects to consider for all relevant attributes.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![clinical-storage-GettyImages-2200933670]( "GMP Clinical Storage Solutions for Today's Complex Trials")
GMP Clinical Storage Solutions for Today's Complex TrialsHow material traits, dosing approaches, and equipment design affect capsule‑filling accuracy and efficiency, giving teams insight to improve dose precision and support small‑scale manufacturing.
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![clinical-supply-GettyImages-1413600685]( "Building Clinical Supply Agility In A Changing Trial Landscape")
Building Clinical Supply Agility In A Changing Trial LandscapeRising trial complexity demands agile supply built on integrated operations, solid planning, and fast issue resolution. Lean teams gain from partners providing flexibility, control, and global reach.
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Addressing Rare Disease Drug Product Manufacturing Challenges
Handling development and manufacturing challenges for orphan drugs requires experience, expertise and scalable technologies, along with a flexible and agile supply chain.
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![iStock-136140244-lab-pharma-equipment-process]( "Speed To Market – API Large-Scale Commercial Manufacturing")
Speed To Market – API Large-Scale Commercial ManufacturingLearn how a top 20 US-based pharma company achieved more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection with the help of a CMO partner.
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![GettyImages-1212860058 clinical trial patient]( "24/7 Cell & Gene Control Tower Provides Agile Solution For Critical Shipments")
24/7 Cell & Gene Control Tower Provides Agile Solution For Critical ShipmentsGet an overview of a successful re-route of six critical shipments to the UK and Spain from Amsterdam used to deliver CAR-T drug products to treat non-Hodgkin’s lymphoma cancer patients.
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![GettyImages-1309776464-medical-research-analysis-lab-computer]( "IRT: A New Approach To Meeting The Needs Of Early Phase Trials")
IRT: A New Approach To Meeting The Needs Of Early Phase TrialsAs early phase clinical trials become more sophisticated, sponsors are now leveraging flexible IRT solutions to replace error-prone manual processes and gain greater control and efficiency.
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![Pharmaceutical packaging pharmacy iStock-840095386]( "3 IRT Tactics Being Used To Streamline Supply Logistics")
3 IRT Tactics Being Used To Streamline Supply LogisticsShipping and storing leading-edge therapeutics require complex logistics, but enhanced automation and process simplification ensure that sites and patients have the drugs they need when they need them.
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![iStock-635767756-clinical-trial-research]( "Building A Flexible, Challenge Resistant, Patient-Centric Clinical Supply Chain")
Building A Flexible, Challenge Resistant, Patient-Centric Clinical Supply ChainFlexible solutions, like demand-led supply and direct-to-patient distribution, are helping sponsors address the growing list of challenges presented by today’s increasingly complex studies.
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![GettyImages-2174865907 workflow, lab, cell therapy]( "Tech Transfer Strategies For mAb Drug Products In Late-Phase Launch")
Tech Transfer Strategies For mAb Drug Products In Late-Phase LaunchTech transfer is not just a process of replicating manufacturing steps; it is a complex, multidisciplinary effort that ensures process robustness, scalability, regulatory compliance, and supply chain readiness.
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![West]( "Vial Containment Systems For Gene And Cell Therapies")
Vial Containment Systems For Gene And Cell TherapiesCZ vial-stopper-seal combinations offer a viable solution for the challenges associated with low-temperature storage of cell therapy drug products.
CATALENT CORNER
| Insights from Catalent's Clinical Supply Experts |
SPONSORED CONTENT
Impact Of Supplier Choice On APAC Clinical Trial Execution
Learn about strategies Asia-Pacific has become an increasingly complex and congested destination for clinical trials as local and global sponsors alike flock to the region to take advantage of its many benefits, including access to large patient pools. Choosing the right clinical packaging and supply chain partner to support these studies is critical and can vary significantly based upon what countries are involved and the types of services required.
