ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Biosample Tracking: A Consenting Dilemma

  Biosample collection is an inevitable part of most clinical trials. Learn how sponsors should be tracking every sample back to the source so as to not violate compliance issues.

• 24/7 Cell & Gene Control Tower Provides Agile Solution For Critical Shipments

  Get an overview of a successful re-route of six critical shipments to the UK and Spain from Amsterdam used to deliver CAR-T drug products to treat non-Hodgkin’s lymphoma cancer patients.

• A Guide To RTSM For Clinical Trials

  Looking ahead, the evolution of RTSM in clinical trials points towards cloud-based solutions, heightened emphasis on patient safety, and greater collaboration among stakeholders. Learn how you can prepare.

• Understanding Post-BREXIT Regulatory Changes Impacting the Clinical Trial Supply Chain

  With many BREXIT provisions now in effect and more to come, supply chains serving clinical trials in the UK and/or EU member states must navigate a complex web of new regulations.

• Ensuring On-Time Release Of CAR-T Cell Treatment In Spain

  Due to the COVID-19 pandemic, and the start of Brexit, a CAR-T cell treatment therapy shipment was offloaded multiple times by the airline, requiring an alternative transport solution.

• Case Management Accelerates Shipment For SCN1A+ Dravet Syndrome Gene Therapy

  Consider this streamlined, end-to-end solution that helped safeguard study timelines and ensured that patients with urgent medical needs could receive treatment without delay.

• A Supply Chain Management Solution Designed for Clinical Research

  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.

• Building A Global Cell And Gene Supply Chain Serving Personalized Medicine

  Clinical distribution paths can be fragile for a multitude of reasons, making it critical that pharmaceutical sponsors and their partners orchestrate supply chain logistics even before site initiation.

• Development And Manufacture Of A Highly Potent OSD Product

  Highly potent drug compounds require advanced containment and robust technical transfer protocols. CDMOs overcome challenges through meticulous testing, specialized tooling, and strong supplier relationships.

• Managing Complex Global Drug Distribution And Expiry

  A global top-ten pharma company sponsored a complex, 8-year Phase III trial across 43 countries. As costs mounted and supplies waned, it realized the trial could be better managed if outsourced.