Consultant Jessica Cordes provides an update on proposed changes to GMP guidance that affect trial conduct, including documentation, computerized systems, and the use of AI.
- 7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies
- Sorriso's Path To Oral Biologics Dosing Is Through The Gut
- EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence?
- What Global Survey Says About Scant Patient Access To CAR-T Therapy
- Scaling Up Manufacturing? Here's Why You Need A CMC Specialist
- Peeling Back The Layers Of Radiolabeled Peptide Production
- Multispecific Trial Supply Stability Hinges On CDMO Agility
- Bracing For The Impact Of The Federal Workforce Reduction
ON-DEMAND WEBINARS
Explore the opportunities to optimize your supply chain strategy and facilitate direct-to-site, direct-to-patient and hybrid services utilizing a global GMP depot network.
This webinar will offer best practices for UAT for sponsor organizations with the aim of changing the conversations and expectations around the UAT process.
The COVID-19 global pandemic took the world by storm, disrupting several industries and our global supply chains. Learn why having a contingency plan and proactively planning gives a company a competitive edge.
If you are in the process of developing a complex or sensitive injectable drug, learn about containment solutions to mitigate your risks and help you get your drug to the patient faster.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Sales Advice Data Analytics]( "Complex Randomization Delivered Successfully")
Complex Randomization Delivered SuccessfullyLearn about the strategy and successful execution of a complex randomization design that helped LG Chem overcome its clinical trial challenges alongside eClinical randomization experts.
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![GettyImages-1254705026 clinical supplies]( "Overcoming The Challenges Of Fragmented Supply Chains")
Overcoming The Challenges Of Fragmented Supply ChainsAs trials grow more complex, managing clinical supplies is increasingly challenging. In this webinar, experts discussed GxP inventory management and integrated solutions to overcome these hurdles.
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![Vials pharma manufacturing GettyImages-618518692]( "Planning Your Packaging For A Seamless Transition From Clinic To Launch")
Planning Your Packaging For A Seamless Transition From Clinic To LaunchExplore how clinical and commercial teams should work together for clinical supply packaging, how the COVID-19 pandemic has changed things, and what to consider when looking for a packaging partner.
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![GettyImages-1305685152 vaccine]( "eClinical Platform Accelerates COVID-19 Treatment Trial By 2 Weeks")
eClinical Platform Accelerates COVID-19 Treatment Trial By 2 WeeksExamine a COVID-19 treatment trial that utilized integrated EDC, eConsent, eCOA, RTSM, and TeleVisit solutions, all within a single platform, to address three critical challenges.
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![GettyImages-1391646149 technology]( "Providing Drug Supply Support In Complex Environments Through IRT")
Providing Drug Supply Support In Complex Environments Through IRTLearn how applying predictive data analytics can enable the creation of an ideal supply strategy capable of reducing the need for extra shipments, manual oversight, and supply waste.
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![West1]( "Prefillable Syringe Plungers: A Solution For Low Temperature Storage")
Prefillable Syringe Plungers: A Solution For Low Temperature StorageReview a study with 1 mL long glass and polymer-based syringes and with 2.25 mL glass syringes. Explore the impacts on plunger movement, container closure integrity, and break loose and extrusion force.
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![GettyImages-179973335 budget]( "The Crucial Role Of IRT/RTSM In Optimizing Drug Supply Budgets")
The Crucial Role Of IRT/RTSM In Optimizing Drug Supply BudgetsExpand your knowledge of IRT/RTSM systems and their capabilities to tailor supplies to site-specific recruitment, significantly decrease drug waste and costs, ensure efficient IMP management, and more.
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![GettyImages-1404941712-Capsules_Blister_Packaging]( "Gain Confidence In Clinical Trial Outcomes")
Gain Confidence In Clinical Trial OutcomesDelve into the ways that smart packaging integrations within clinical trial strategies can improve adherence to dosing protocols and provide a comprehensive understanding of a patient’s exposure.
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![GettyImages-184945838-cold-chain-cryopreservation]( "Building A Global Cell And Gene Supply Chain Serving Personalized Medicine")
Building A Global Cell And Gene Supply Chain Serving Personalized MedicineClinical distribution paths can be fragile for a multitude of reasons, making it critical that pharmaceutical sponsors and their partners orchestrate supply chain logistics even before site initiation.
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![GettyImages-1404326328 computer, research]( "From Frustration To Organization: An SSO Platform For Trial Sites")
From Frustration To Organization: An SSO Platform For Trial SitesTo reap the benefits of tech innovation, sponsors and sites need a single sign-on (SSO) solution that enables streamlined organization across different trials and clinical systems.
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.
