ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

• Tech Transfer Strategies For mAb Drug Products In Late-Phase Launch

  Tech transfer is not just a process of replicating manufacturing steps; it is a complex, multidisciplinary effort that ensures process robustness, scalability, regulatory compliance, and supply chain readiness.

• The Crucial Role Of IRT/RTSM In Optimizing Drug Supply Budgets

  Expand your knowledge of IRT/RTSM systems and their capabilities to tailor supplies to site-specific recruitment, significantly decrease drug waste and costs, ensure efficient IMP management, and more.

• 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.

• Precision and Compliance in Pharmaceutical Packaging

  Reliable, compliant packaging preserves product integrity, supports regulatory readiness, and lowers risk. Careful components and controlled processes keep complex therapies protected.

• 3 IRT Tactics Being Used To Streamline Supply Logistics

  Shipping and storing leading-edge therapeutics require complex logistics, but enhanced automation and process simplification ensure that sites and patients have the drugs they need when they need them.

• 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.

• RTSM: Randomization And Cohort Management, IP Inventory Management

  Signant’s SmartSignals® RTSM solution helped an innovative biopharmaceutical company secure an FDA Orphan Drug designation for its cardiomyopathy drug.

• Considerations When Selecting An Interactive Response Technology Provider

  Interactive response technology (IRT) systems ensure clinical trial participants receive the correct treatment, facilitate enhanced logistics tracking, and empower users to obtain real-time data.

• Sample Sizes For Performance Testing Of Combination Products, Packaging

  When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.