White Papers

1. The Untapped Power Of Real-World Data And AI In Pharma Commercialization 8/27/2025

   Harnessing RWD in commercialization bridges the gap between approval and patient access, equipping companies with actionable intelligence to deliver life-changing therapies to more patients.

2. Master Protocols: Implementing Effective Treatment Adaptations 8/25/2025

   From balancing treatment ratios and managing subgroup eligibility to accommodating site-specific readiness and protocol amendments, a flexible, well-designed IRT system enables seamless transitions with minimal disruption.

3. Unique IRT Implementation Considerations For Personalized Medicine Trials 8/22/2025

   The rise of personalized and precision medicine is reshaping the clinical trial landscape and, as the number of these specialized trials increases, so does the complexity of managing them effectively.

4. Project Orbis Drug Registration 2025 8/22/2025

   Project Orbis helps streamline the review and approval of oncology medicinal products through international regulatory collaboration. Learn how this framework can accelerate your regulatory strategy.

5. Unlock Oncology Success With A Comprehensive Commercialization Guide 8/22/2025

   Navigate the complex process of bringing an oncology therapy to market, from regulatory planning to patient access and supply chain logistics, with this comprehensive handbook for developers.

6. Patient-Focused Data Capture For Cancer Research 8/21/2025

   In a field where innovation is constant and patient experience is pivotal, oncology demands eCOA solutions designed to balance scientific rigor with human realities.

7. 2025 Global Report For In-Vivo CAR Cell Therapy 8/14/2025

   Explore global trends shaping in-vivo CAR therapies—delivery innovations, clinical trial momentum, and regulatory strategies across oncology and autoimmune diseases.

8. LBPs: Unique Quality, Manufacturing, And Nonclinical Considerations 8/14/2025

   Live biotherapeutic products (LBPs) are emerging as a dynamic area of drug development, and their development demands tailored strategies that address both manufacturing and nonclinical complexities.

9. Understanding Immunogenicity In AAV Gene Therapy 8/14/2025

   As adeno-associated virus-based gene therapies progress toward clinical use, effectively managing immunogenicity risk is critical to patient selection, therapeutic durability, and regulatory success.

10. Demanding More From AI Governance In Drug Safety 8/13/2025

    Embedding AI governance into your an AI-enabled safety system from the start empowers trust and streamlines the path toward success; it is merely the evolution of good data and risk governance.