ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Inside A Gene Therapy Facility, Commercialization & Industrialization Project

  An inside look at a clinical-stage company focused on bringing its gene therapy from the lab into a clinical setting for patients and families devastated by rare neurological genetic diseases. 

• 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.

• Cryobag Container Development For Cell & Gene Therapies

  ISR Reports addresses the logistical challenges faced by developers of cell and gene therapies regarding cold chain and cryopreservation.

• 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.

• Outsourcers Are Feeling Uneasy About Continuity Of Supply

  Find out how COVID-19 complications have picked up from the first year, with more outsourcers experiencing bigger obstacles when it comes to manufacturing, specifically with drug product.

• What To Look For In Your IRT/RTSM Solution For A Simpler Trial Execution

  Which factors should you consider when selecting an IRT/RTSM vendor to ensure your trial's randomization and supply management processes are successfully executed?

• Optimizing Clinical Trials In China With Strategic Solutions For Supply Chain

  Plan proactively for clinical trials in China by aligning with National Medical Products Administration requirements and leveraging Free Trade Zones to streamline regulatory approvals and clinical supply importation.

• The Critical Role Of Clinical Trial Packaging Services In Trial Success

  Compliant, accurate packaging protects product integrity, supports dosing consistency, and keeps studies running smoothly. Smart components and controlled processes lower risk across complex trials.

• IRT? RTSM? What's The Difference?

  What are the components of Randomization and Trial Supply Management (RTSM) and the critical role of RTSM and Interactive Response Technology (IRT) in clinical trials?

• Navigating Audit Trail Data Regulations And Accessibility Changes

  Data is the single most important thing in a clinical trial. Leverage the power of clinical trial data with effective utilization and access in a changing regulatory landscape.