ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

• Building Better Resilience Into Your Clinical Supply Strategy

  Reliable clinical supply requires proper vendor selection, cross-functional communication, and safety nets built to accommodate an ever-changing geopolitical and global pharmaceutical landscape. To avoid supply disruptions for clinical drugs, sponsors must give clinical supply its proper weight in initial protocol development and trial design.

• Improving Clinical Trial Label Translation Through Centralized Reuse And Control

  Eliminate workflow inefficiencies and regulatory risk in global trials with a centralized translation framework and validated phrase library for consistent, cost-effective execution.

• Rethinking RTSM Software: When Bigger Isn't Better

  Don’t let legacy vendor inertia jeopardize your trial. Discover why agility and deep RTSM expertise are the new benchmarks for reducing risk and ensuring precision in clinical operations.

• Lifecycle Planning For Containment And Delivery Of Biologics Drug Products

  Read more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development.

• Delivering Lifesaving Intravenous Therapy Across The USA Within 24 Hours

  The goal was to successfully deliver time-critical intravenous therapy, Legalon, from a GMP Philadelphia depot to sites across the USA to treat patients suffering from amatoxin poisoning.

• Modern Architecture's Impact On UX In Next-Gen Interactive Response Tech

  Explore how Interactive Response Technologies (IRTs) built around microservices models can provide faster initial builds, more rapid change management, and improved built-in test automation.

• How Long Is Your RTSM Risk Mitigation List?

  While RTSM systems help reduce many of the risks in clinical trials, each trial’s unique setup necessitates a risk analysis to identify trial-specific challenges.

• 3 Reasons Sponsors Should Own The RTSM Vendor Relationship

  Explore how direct management of study randomization and supply chains reduces communication delays, improves system design, and protects clinical data integrity from accidental unblinding.

• 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.