ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Improving Site Efficiency With Automated Drug Resupply And Forecasting

  Interactive Response Technology (IRT) can transform site operations by replacing error-prone manual processes with real-time, automated systems that relieve some of the burden on trial sites.

• 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.

• 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.

• 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.

• Key Considerations For Emerging Companies When Selecting Packaging Components

  Recognizing the importance of packaging development and prioritizing its role in drug development early on can help proactively identify potential delays and overcome risks.

• 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?

• 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.

• FastChain®: A Solution For Made-To-Order Gene Replacement Therapy Study

  Adopt a demand-led clinical supply strategy to reduce waste, optimize limited product supply, and accelerate patient access across global clinical trials.

• Internal Validation Study: Ultra-Low Temperature Labels

  Clinical trial vials held at ultra-low temperatures need labels that stay put. Three label formats, applied under dry ice conditions, were compared for qualification.

• From Frustration To Organization: An SSO Platform For Trial Sites

  To reap the benefits of tech innovation, sponsors and sites need a single sign-on (SSO) solution that enables streamlined organization across different trials and clinical systems.