ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

• 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.

• Key Considerations For Packaging Solutions For Cell And Gene Therapies

  Thinking of packaging and delivery factors early and often will minimize risks to the safety and efficacy of your cell and gene therapy drug product from the bench to the patient.

• How Modern Software Architecture Is Revolutionizing IRT Solutions

  Explore the ways technology suppliers across the clinical trial space have begun investing in IRTs built around a microservices model capable of improving data access and visibility.

• Building Clinical Supply Agility In A Changing Trial Landscape

  Rising trial complexity demands agile supply built on integrated operations, solid planning, and fast issue resolution. Lean teams gain from partners providing flexibility, control, and global reach.

• Optimizing IRT For Clinical Supply Management

  Experts speak on supply capabilities within interactive response technology (IRT) – how flexibility is important to functionality and who to involve and which questions to ask in optimizing IRT for clinical supply.

• 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.

• Distributing Clinical Supply In The EU For Compassionate Use Programs

  Explore the logistical and distribution risk management factors that need to be considered when planning an EU Compassionate Use Program, especially when faced with COVID-19 closures and challenges.

• Developing Injectable Drug Placebo Formulations For Clinical Trials

  Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.

• Critical Requirements In Sourcing Comparator Drugs

  Sourcing comparator drugs has become complex in the clinical supply chain. As a result, clinical trial sponsors and pharma companies are eager to identify opportunities to overcome these challenges.