CLINICAL SUPPLY REGULATORY ARTICLES
FDA Issues Bioresearch Monitoring Technical Specifications Document To Help You Organize Your Submission
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.
CLINICAL SUPPLY REGULATORY VIDEOS
Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.
Achieving supply chain resilience is crucial, and flexible distribution strategies and ready-to-use depot and logistics networks are instrumental in establishing limitless flexibility and expertise capable of identifying possible risks.
Choosing the right clinical packaging and supply chain partner to support APAC studies can vary significantly based upon which countries are involved and the types of services required.
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
CLINICAL SUPPLY REGULATORY RESOURCES
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![iStock-1214764688-scientist-lab-analyze-research]( "Global Clinical Supply Solutions For Every Trial")
A reliable clinical supply chain strategy is as essential as a company’s discovery program. Seek a partner who can help guide a comprehensive strategy and manage day-to-day activities.
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![audit management]( "Optimizing Direct-To-Patient Supply Management: ClinChoice And 89Bio")
Learn how the CRO ClinChoice and the sponsor 89Bio were conducting a phase II, randomized, double-blind, placebo-controlled study that needed to pivot to a decentralized protocol during the pandemic or face trial disruption.
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![GettyImages-1163506017 labeling]( "IMP Labeling: EU CTR Transition Considerations")
Review current requirements as outlined by the EU Clinical Trial Regulation, supporting guidance, and three key considerations when planning IMP labeling activities for ongoing studies.
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![iStock-1224887299-box-logistics-package]( "The Changing Dynamics Of The Pharma/Biotech Supply Chain – A Packaging And Clinical Supply Perspective")
Perhaps more than any other industry, pharma and biotech have undergone radical change over the past year, as a result of the COVID-19 pandemic. From supply chain security and capacity to clinical trial operations and site auditing, almost every aspect has been affected. Experts explore how these trends are shaping the industry and offer an outlook.
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![GettyImages-1189150676-Medicinal_Marijuana_Cannabis_ControlledSubstance]( "Controlled Substances In Clinical Trials")
Handling controlled substances presents layers of complexity. Partnering with an experienced CDMO is essential for managing scheduled materials during clinical studies.
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![Ampoule Aseptic Filling GettyImages-1490244818]( "Advantages Of Robotic Aseptic Processing")
Examine the robotic technologies poised to increase manufacturing flexibility and efficiency while minimizing risk when bringing biologics to market.
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![GettyImages-1327568875-technology-clinical trials-computer-medicine-research]( "A Smart Solution To Clinical Supply Management")
Delve into a solution that ensures the efficient delivery of trial materials worldwide, while navigating the challenges of more complex study designs and the ever-evolving regulatory landscape.
