Articles, App Notes, Case Studies, & White Papers

  1. Outlook 2025: Key Trends & Insights 2/19/2025

    Dive into the key trends and challenges shaping the year ahead, from geopolitical uncertainties to cutting-edge innovation in AI, oncology, and weight-loss therapies.

  2. Outsourcing Your Highly Potent Oncology Drug Product 4/6/2023

    Precision oncology treatments require specialized manufacturing and packaging, leading companies to outsource production. Assessing a CDMO’s highly potent processing capabilities is critical.

  3. Developmental Testing Of IV Solutions 2/10/2022

    As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.

  4. 5 Ways To Get Ready For IRT Regulatory Inspections 7/31/2025

    Preparing for a regulatory inspection during a clinical trial can be daunting. Learn about the importance of clear roles, audit trails, data integrity, and training, and get recommendations to help.

  5. Overcome Vaccine Development Complexities With The Right Supply Chain Partner 7/5/2022

    Explore the challenges impacting clinical supply chains and solutions to overcome these complexities, and understand why it is crucial to pick the right supply chain provider for vaccine storage and distribution.

  6. Top 5 Dos And Don'ts Of RTSM 7/16/2024

    Discover best practices and common pitfalls for sponsors and vendors in RTSM as well as how to optimize your study by leveraging vendor expertise, avoiding delays, and embracing innovation.

  7. Ensure Seamless, Efficient Delivery Of Clinical Trial Materials Worldwide 1/12/2023

    Drug discovery companies, CROs, and CDMOs are under pressure to find supply management solutions that ensure delivery of clinical trial materials while navigating complex study designs and the regulatory landscape.

  8. Enhancing Clinical IP Efficiency & Compliance 8/16/2024

    A U.S.-based clinical research sponsor optimized their supply chain visibility, reduced costs and risks, and improved efficiency by replacing their manual inventory management system.

  9. Consolidating Clinical Supply Chain Operations With GxP Inventory 4/18/2024

    A Japan-based biotechnology company leveraged Signant SmartSignals® GxP Inventory, which improved visibility, reduced risks and costs, and optimized operations in this case study.

  10. Solutions For Sponsors Utilizing Drafted Guidance For PROs In Oncology 11/20/2024

    Explore the challenges pharmaceutical companies face in implementing PROs in cancer clinical trials as outlined in the FDA’s draft guidance, as well as strategies to overcome these obstacles.