Articles, App Notes, Case Studies, & White Papers
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Is Your Clinical Supply Strategy Ready For EU CTR?
3/3/2022
One of the most significant changes in the new EU regulation is Annex VI, which covers changes in the labelling requirements for investigational medical products (IMPs). So, what are the implications of these changes and how will they affect outer immediate packaging?
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Developmental Testing Of IV Solutions
2/10/2022
As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.
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Clinical Manufacturing: What It Is And How It Works
2/27/2022
Clinical 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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The Crucial Role Of IRT/RTSM In Optimizing Drug Supply Budgets
10/4/2024
Expand 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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Logistics In Cell Therapy: Reducing Workflow Risk
6/19/2023
Explore key steps that should be taken when executing a cell therapy clinical trial, from selecting the right sites to optimizing study retention.
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5 Common Clinical Supply Chain Speedbumps
Clinical trials can be very complex. Discover the need to connect planning and oversight from sourcing to shipping, along with mastering requirements such as cold chain, border slowdowns, and data privacy.
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Inside A Gene Therapy Facility, Commercialization & Industrialization Project
3/10/2021
An 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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Overcoming Obstacles To Deliver Critical Autologous Cell Therapy
3/25/2023
See how teams ensured a seamless route, including on-time customs clearance and delivery of autologous cell therapy, from the U.S. to a manufacturing site in Germany
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Overcoming The Challenges Of Fragmented Supply Chains
1/27/2025
As 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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Overcoming Inventory Challenges For A Complex, Global Study
7/14/2022
Explore how the optimization of Interactive Response Technologies (IRT) settings relieved the burden of managing global supply needs for a CRO customer and clinical sponsor.