Protocol Design White Papers & Case Studies

  1. Combining Automation And Human Expertise For Custom Kitting 5/2/2025

    While automated inventory management systems play a crucial role in tracking samples, kit availability, and supply levels human involvement is still important to the adaptability of a clinical trial.

  2. EHR-To-EDC Success In A Complex, Adaptive Platform Trial 4/17/2025

    I-SPY 2, one of the longest-running adaptive platform trials in oncology, is revolutionizing breast cancer research through a dynamic, data-driven approach to evaluating novel therapies.

  3. Delivering Specialist Neurology Support 4/17/2025

    Explore a strategic approach to a Parkinson’s disease trial that leveraged a global infrastructure and multilingual workforce to provide seamless operational and clinical support.

  4. Accelerating Early Phase Oncology Study Development 4/17/2025

    Explore a close collaboration to co-develop a comprehensive, adaptive protocol designed to support key decisions across multiple trial phases for an innovative cancer therapy.

  5. Accelerate Your Oncology Breakthroughs 4/16/2025

    Finding the right partnership can help your oncology clinical trials overcome trial complexities through strategic planning, a deep scientific understanding, and operational excellence.

  6. How Digitized Protocols Are Accelerating Clinical Research 4/15/2025

    Digitized protocols, enhanced by artificial intelligence (AI), are transforming clinical trial operations by accelerating document generation, system integration, and trial optimization.

  7. Streamlining Phase I/II Oncology Trials: A Global CRO Partnership 3/17/2025

    Through strategic planning, adaptive trial execution, and proactive collaboration, TFS successfully navigated the complexities of this early-phase oncology study.

  8. Tailored Solutions For A Global Phase III Neovascular AMD Study 3/17/2025

    How did a Phase III combination study for neovascular age-related macular degeneration (AMD) overcome study complexities while expanding across 16 countries?

  9. Pioneering Gene Therapy In Rare Diseases 3/17/2025

    Overcoming barriers to gene therapy development requires continued innovation in manufacturing processes, harmonized regulatory approaches, and outcome-based pricing models.

  10. Unpacking FDA's Final Rule To Regulate LDTs 3/14/2025

    Discover how the FDA's rule redefines diagnostic testing by classifying laboratory-developed tests (LDTs) as medical devices to ensure stricter oversight and consistent standards for safety and efficacy.