FDA demographic mandates can upend global trial supply, stranding inventory, driving panic packaging, and creating hidden bias that undermines study execution.
- At The Point Of Review: How Clinical Shipments Are Evaluated In Practice
- The cGMP Reality Of Clinical Supply For Advanced Therapies
- How Exit Strategy Should Shape Clinical Trial Supply Planning
- This Assumption Will Break Your Clinical Trial
- When Clinical Supply Fails, Small Biotech Trials Stall
- Putting Vaccine Supply Resilience To The Test: The Last Mile
- How Clinical Supply Drives Resilience In Global Vaccine Networks
- From Inconsistency To Structure: A Model For Defensible Compliance Decisions
ON-DEMAND WEBINARS
Expert speakers discuss current operational obstacles and explore strategic solutions to optimize a supply chain strategy in the years ahead.
This webinar will offer best practices for UAT for sponsor organizations with the aim of changing the conversations and expectations around the UAT process.
Learn how to synthesize individual symptomatic data into a comprehensive narrative of tolerability, ultimately enhancing the clinical value and regulatory positioning of your oncology assets.
In the era of seamless development, reducing time to the clinic and getting rapid approval is key. An integrated approach can accelerate timelines, avoid communication pitfalls, and improve outcomes.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![Getty-1652511983-supply-chain-management]( "A Custom IRT System Facilitates Precision Medicine Studies")
A Custom IRT System Facilitates Precision Medicine StudiesAs the industry continues to embrace personalized medicine, the ability to implement and support an atypical supply chain is crucial.
-
![iStock-1088247762-risk]( "Avoiding The Risk Of A Non-Transparent Clinical Supply Solution")
Avoiding The Risk Of A Non-Transparent Clinical Supply SolutionWith the supply chain and transportation logistics disruption caused by the COVID-19 pandemic, full documentation and complete transparency becomes even more important to avoid delays and assert provenance.
-
![Supply Chain - Getty- 1159559071]( "Is Your Clinical Supply Chain Fully Optimized?")
Is Your Clinical Supply Chain Fully Optimized?Streamlined supply chain operations alleviate staff workload and significantly reduce IP waste. With the right partners, you can create a fully optimized, cost-effective supply chain strategy.
-
![GettyImages-836663414 medical team meeting]( "Sponsor Overcomes Hold And Steers Products Through Development")
Sponsor Overcomes Hold And Steers Products Through DevelopmentUncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.
-
![GettyImages-1616837193 coworkers tablet]( "How A Biotech Startup Transformed Their Clinical Trial Supply Management")
How A Biotech Startup Transformed Their Clinical Trial Supply ManagementDon’t let your trial get lost in the shuffle of legacy vendors. See how a high-touch, consultative approach can protect your study’s future.
-
![deadlines time management-GettyImages-1350531674]( "How Modern RTSM Platforms Are Eliminating Delays")
How Modern RTSM Platforms Are Eliminating DelaysStop letting rigid legacy RTSM systems stall your clinical trials. Learn why manual change requests cause months of delays and how a modern, platform-based approach restores your study’s agility.
-
![pharma-packaging-GettyImages-1938951579]( "Precision and Compliance in Pharmaceutical Packaging")
Precision and Compliance in Pharmaceutical PackagingReliable, compliant packaging preserves product integrity, supports regulatory readiness, and lowers risk. Careful components and controlled processes keep complex therapies protected.
-
![GettyImages-1751848523-meeting-evaluation-charts-table]( "Writing Effective Clinical Regulatory Documents For Therapy Trials")
Writing Effective Clinical Regulatory Documents For Therapy TrialsClinical medical writing for gene therapy regulatory documents is a demanding, detail-oriented task that diverges significantly from medical writing for more traditional therapies.
-
![GettyImages-871431000 doctor partner]( "3 Reasons Sponsors Should Own The RTSM Vendor Relationship")
3 Reasons Sponsors Should Own The RTSM Vendor RelationshipExplore how direct management of study randomization and supply chains reduces communication delays, improves system design, and protects clinical data integrity from accidental unblinding.
-
![GettyImages-155372946-cold-chain-cryopreservation-logistics]( "Ensuring On-Time Release Of CAR-T Cell Treatment In Spain")
Ensuring On-Time Release Of CAR-T Cell Treatment In SpainDue to the COVID-19 pandemic, and the start of Brexit, a CAR-T cell treatment therapy shipment was offloaded multiple times by the airline, requiring an alternative transport solution.
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.
