The FDA has issued the latest version of Bioresearch Monitoring Technical Conformance Guide: Technical Specifications Document: version 3.1. This version will likely be in place for a significant length of time as a road map for constructing this part of the NDA or BLA that you submit.
- Massive Data, More Decentralization Drive Updates To ISPE GAMP Guide
- A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies
- 5 Strategic Advantages Of Manufacturing ADCs In-house
- When Should You Select Your Supply Partner?
- If The CDMO Shoe Fits, Wear It Now
- Warning To U.S.-Based CDMOs: Don't Get Complacent
- A 5-Step Approach To Strengthen Clinical Trial Partnerships In Low- And Middle-Income Countries
- Luxturna Maker Spark Therapeutics' Flexible Platform Approach
ON-DEMAND WEBINARS
Join Guido D’Agostino, Head of Global Procurement at Chiesi, and Stefan Dürr, Senior Director of Product Management and Client Delivery at IQVIA IRT, as they delve into their achievements in sustainability.
This webinar provides strategies for clinical supply planners to make immediate improvements in their strategy as well as discuss the need for a holistic end-to-end approach to supply planning.
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 presents the ultimate guide to scenario planning through modern technology as a way to inform clinical supply decisions.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![iStock-1293772969-lab-microscope-scientist-research]( "Clinical Manufacturing: What It Is And How It Works")
Clinical Manufacturing: What It Is And How It WorksClinical manufacturing is a specialized form of pharmaceutical manufacturing focused on producing drugs for clinical research. How does it work and how is it different from commercial manufacturing?
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![GettyImages-970394878-genetic-engineering-gene-editing-dna]( "Inside A Gene Therapy Facility, Commercialization & Industrialization Project")
Inside A Gene Therapy Facility, Commercialization & Industrialization ProjectAn inside look at a clinical-stage company focused on bringing its gene therapy from the lab into a clinical setting for patients and families devastated by rare neurological genetic diseases.
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![Getty-1652511983-supply-chain-management]( "Hidden Benefits Of Clinical Forecasting & Supply Planning Solutions")
Hidden Benefits Of Clinical Forecasting & Supply Planning SolutionsStreamline clinical supply chain management with SmartSignals Supplies, reducing errors and inefficiencies from spreadsheet-based forecasting.
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![GettyImages-1254705026 clinical supplies]( "Using Tech Enabled Solutions To Boost Productivity And Sustainability")
Using Tech Enabled Solutions To Boost Productivity And SustainabilityClinical trials continue to face challenges related to cost, patient technology adoption, and resource management. Uncover how investing in suitable tech solutions can enhance efficiency and reduce companies' carbon footprint.
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![Vaccine Manufacturing GettyImages-1384850913]( "GxP Inventory Enhances Supply Chain For Global Specialty Biotech Firm")
GxP Inventory Enhances Supply Chain For Global Specialty Biotech FirmDiscover how the simplification and digitization of clinical supply chain operations enhanced transparency, lowered risks and expenses, and optimized efficiency.
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![Doctor Preparing Injection Site GettyImages-1379313214]( "A Practical Packaging Components Checklist For Emerging Biotechs")
A Practical Packaging Components Checklist For Emerging BiotechsA proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations in selection components for your injectable drug product.
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![GettyImages-157291618 Scientist inspecting vial]( "Understanding Injectable Drug Container Closure Systems")
Understanding Injectable Drug Container Closure SystemsChoosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.
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![Fisher]( "Scaling The Advanced Therapy Supply Chain")
Scaling The Advanced Therapy Supply ChainThis case study describes the use of dispersed storage and cold chain logistics, around a central manufacturing facility to create a cost efficient and robust supply chain.
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![Doctor Clinical Trial]( "IRT? RTSM? What's The Difference?")
IRT? RTSM? What's The Difference?What are the components of Randomization and Trial Supply Management (RTSM) and the critical role of RTSM and Interactive Response Technology (IRT) in clinical trials?
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![Singota-DSC03221]( "Developmental Testing Of IV Solutions")
Developmental Testing Of IV SolutionsAs IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.
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.
