Protocol Design White Papers & Case Studies

31. 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?

32. 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.

33. 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.

34. Antibody-Drug Conjugates: 'Magic Bullets' Become Reality 2/19/2025

    Cancer therapy has evolved from potent chemotherapy to targeted biological therapy, including antibody-drug conjugates (ADCs). Learn more about ADCs’ makeup, mechanisms, and the development landscape.

35. Triple-Negative Breast Cancer: Global Clinical Trial Landscape 1/30/2025

    With over 1,500 TNBC-focused clinical trials since 2019, research efforts into Triple-negative breast cancer (TNBC) treatments are accelerating despite challenges such as drug resistance.

36. Fit-For-Purpose Biomarker Development 1/17/2025

    Here, we highlight the essential framework of a “fit-for-purpose” biomarker development strategy, emphasizing strategic and transactional engagements with clinical research organizations.

37. Maximizing Efficiency: A Comprehensive Guide To Study Coordination Services 1/14/2025

    Explore the critical role of study coordinators, emphasizing their expertise, strategic contributions, and the value they add to clinical research.

38. Optimizing Early-Stage Oncology 1/14/2025

    A strategic partnership enables a U.S. biotech company to address the struggles with their Phase I first-in-human oncology trial.

39. Your Global CRO Partner In Oncology And Hematology 1/14/2025

    Learn about an organization dedicated to providing personalized and adaptive trial solutions and managing complex oncology and hematology clinical trials.

40. Taking Research In-House With CRIO: SciTech's Multi-Center Phase 1 Study 1/6/2025

    Explore the success story of an early-stage clinical pharmaceutical company that effectively navigated funding constraints when conducting its Phase 1 study without a third-party CRO.