Articles, App Notes, Case Studies, & White Papers
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A Supply Chain Management Solution Designed for Clinical Research
8/4/2023
In this use case, follow along the clinical supplies management journey to learn how GxP Inventory replaces fragmented, spreadsheet-based processes to optimize visibility, traceability, and compliance.
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Roles And Responsibilities Of Specialized Clinical Supply Experts
Explore the important roles of the Project Manager, Clinical Supply Manager, and Financial Project Analyst, whose responsibilities contribute to clinical supply expertise and study success.
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Treating Deficiencies In Employee Training And Mentorship
5/3/2024
Investing in employee training and development is not just beneficial for the employees. It also contributes significantly to the organization’s success and competitive advantage.
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Ensure Seamless, Efficient Delivery Of Clinical Trial Materials Worldwide
1/12/2023
Drug discovery companies, CROs, and CDMOs are under pressure to find supply management solutions that ensure delivery of clinical trial materials while navigating complex study designs and the regulatory landscape.
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Using Tech Enabled Solutions To Boost Productivity And Sustainability
5/1/2024
Clinical 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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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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How Modern Software Architecture Is Revolutionizing IRT Solutions
8/10/2023
Explore the ways technology suppliers across the clinical trial space have begun investing in IRTs built around a microservices model capable of improving data access and visibility.
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Cryobag Container Development For Cell & Gene Therapies
12/8/2022
ISR Reports addresses the logistical challenges faced by developers of cell and gene therapies regarding cold chain and cryopreservation.
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The RMAT Designation: What It Means To The Advanced Therapy Supply Chain
The RMAT designation gives the sponsor of a new drug access to increased meeting opportunities with FDA, in a manner comparable to those offered to sponsors of breakthrough-designated therapies. In fact the RMAT may be considered as analogous to the breakthrough designation for regenerative medicine drugs.
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Thinking Outside Of The Freezer: DNA And RNA Storage
3/8/2019
While ultra-low temperatures are the current state-of-the-art solution for biospecimen storage, ambient storage is an interesting option and could be superior in certain limited situations. For many types of samples, it’s possible that we will always have to use ultra-low temperatures for long-term storage. For other sample types, such as DNA and RNA, there are alternative solutions.