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Catalent Adds New Cryogenic Capabilities at Shiga, Japan, Facility to Support Clinical Supply Demand for Cell and Gene Therapy Development

The Pharma Data

The expansion forms part of Catalent’s ongoing global strategy to increase its ability to handle, store and manage advanced therapies for clinical supply, and follows investments at its facilities in Philadelphia, Singapore, and Shanghai, China, in specialized, ultra-low temperature storage capabilities. With sites in the U.S.,

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Optimizing Clinical Trial Management: The Role of Site Monitoring Metrics and KPIs

Cloudbyz

Regulatory Compliance: Metrics such as protocol deviation rates and audit outcomes can ensure the trial remains compliant with regulatory guidelines, reducing the risk of regulatory issues or penalties. In conclusion, clinical site monitoring metrics and KPIs are integral to the successful management and oversight of clinical trials.

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Importer of Record for Clinical Trials

Imperical Blog

Avoiding “Customs Chaos” in Clinical Trials Means Working Closely with Your Importer of Record Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinical trials.

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Importer of Record for Clinical Trials

Imperical Blog

Avoiding “Customs Chaos” in Clinical Trials Means Working Closely with Your Importer of Record Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinical trials.

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A supply chain to match the changing face of science 

Drug Discovery World

The cost of a process failure on these therapies is high, as is the resulting pressure on actors within the supply chain. TrakCel recently supported a client through a labeling change deployed through the COS for compliance and control reasons. References .