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
Guido D’Agostino, Head of Global Procurement at Chiesi, and Stefan Dürr, Senior Director of Product Management and Client Delivery at IQVIA IRT, delve into their achievements in sustainability.
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
Want to know more about the growth and expansion of IRT in the decentralized trial space? Witness how IRT is being used to support direct-to-patient delivery in this hybrid trial case study.
Join patient-centric supply chain expert Marco Hogenboom for a discussion on how to accelerate the delivery of advanced therapies in an unpredictable environment through supply chain customization from clinical to commercialization.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1288118586 cell development]( "Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials")
Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical TrialsLearn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.
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![GettyImages-1296498102 lab technician]( "Clinical Supply Optimization: Process Improvement Accelerates Trials")
Clinical Supply Optimization: Process Improvement Accelerates TrialsA biopharmaceutical sponsor required the study start-up phase to be reduced to 91 days, involving comparator sourcing and blinding, kitting, packaging, labeling, and distribution to the sites.
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![GettyImages- 1317948272 drug delivery]( "RTSM Manages Clinical IP Dispensation In Schizophrenia Study")
RTSM Manages Clinical IP Dispensation In Schizophrenia StudyChallenged by the dispensation of an investigational product (IP) across diverse patient subgroups, see what solution this pharma was able to utilize to ensure optimal distribution and minimize wastage.
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![GettyImages-1156884561-fill-finish]( "Key Considerations For Selecting Flexible Fillers")
Key Considerations For Selecting Flexible FillersFlexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.
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![GettyImages-1312767504 data health]( "Blinded Randomization And Trial Supply Management Gets Support")
Blinded Randomization And Trial Supply Management Gets SupportUncover how this global specialty pharmaceutical company was able to ensure the confidentiality of its blinded study data while receiving flexible and scalable unblinded support.
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![Ampoule Aseptic Filling GettyImages-1490244818]( "Advantages Of Robotic Aseptic Processing")
Advantages Of Robotic Aseptic ProcessingExamine the robotic technologies poised to increase manufacturing flexibility and efficiency while minimizing risk when bringing biologics to market.
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![gettyimages-946264212-170667a]( "Navigate Complex Ancillary Supply Sourcing Challenges")
Navigate Complex Ancillary Supply Sourcing ChallengesExplore the evolvement of the clinical trial landscape over recent years, as well as the new challenges that this poses for the clinical supply chain.
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![BCS2024-1341-05MAY---IQVIA-IRT-Clinical-Trials-Arena-Award-THUMB]( "Streamlining Clinical Supply With Advanced Automation")
Streamlining Clinical Supply With Advanced AutomationClinical trials are the backbone of pharmaceutical advancements, but they come with their own set of challenges, particularly in data management and supply chain logistics.
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![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.
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![GettyImages-1312767504 data health]( "Using IRT Data To Automate And Optimize Clinical Supply")
Using IRT Data To Automate And Optimize Clinical SupplyLearn how clinical teams can save between $150,000 and $1 million in annual drug and shipping costs through automated supply optimization.
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.
