ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Avoiding The Risk Of A Non-Transparent Clinical Supply Solution

  With the supply chain and transportation logistics disruption caused by the COVID-19 pandemic, full documentation and complete transparency becomes even more important to avoid delays and assert provenance.

• 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.

• Overcoming The Complex Logistics Of Autologous Cell Therapy Trials: A Deep Dive Into Challenges And Solutions

  Explore critical logistical requirements in autologous cell therapies logistics and learn how to overcome challenges and achieve successful and timely autologous cell therapy trials.

• How Modern RTSM Platforms Are Eliminating Delays

  Stop letting rigid legacy RTSM systems stall your clinical trials. Learn why manual change requests cause months of delays and how a modern, platform-based approach restores your study’s agility.

• Is Your Clinical Supply Strategy Ready For EU CTR?

  One of the most significant changes in the new EU regulation is Annex VI, which covers changes in the labelling requirements for investigational medical products (IMPs). So, what are the implications of these changes and how will they affect outer immediate packaging? 

• How Clinical Trial Complexity Impacts End Users

  This article examines clinical trial complexity through the lens of study investigators, site staff, CRAs, sponsor study and supply managers, and how the RTSM/ IRT provides the ability to be as creative as needed.

• Winning The Race To FPI With Early Randomization And Trial Supply Management

  Learn why the ability to get investigational products to sites, and appropriately store them, is not a given – and this oversight can have serious consequences. 

• Advancing Your API To First Human Dose Trials More Efficiently

  Learn how end-to-end support for development and manufacturing, clinical trial services, advanced drug delivery, and commercial packaging can accelerate drug development and time to market.

• Overcoming Cell Therapy Supply Chain Challenges

  For the industry to realize the potential of cell and gene therapies (CGTs), we must develop improved solutions that reliably support the control and transport of critical CGT raw materials and products.

• Clinical Supply Optimization: Process Improvement Accelerates Trials

  A biopharmaceutical sponsor required the study start-up phase to be reduced to 91 days, involving comparator sourcing and blinding, kitting, packaging, labeling, and distribution to the sites.