Featured Articles

41. Backup Sites: The Closers Of Clinical Trials 4/22/2024

    Backup or coverage sites are usually brought in at the same time as others but are not activated. These sites become add-on or rescue sites, or the clinical equivalent of baseball’s ninth inning.

42. Pharma R&D Annual Review 2024 4/22/2024

    As we reflect on the past year's accomplishments and challenges, our insights serve as a beacon for driving innovation, fostering collaboration, and advancing global healthcare outcomes.

43. Considerations For Plain Language Summaries 4/22/2024

    Recent FDA emphasis on plain language underscores a shift towards greater transparency and patient understanding, highlighted in the joint FDA and Office for Human Research Protections (OHRP) draft guidance.

44. Diversity In Clinical Trials: Walking The Walk 4/22/2024

    Discover why achieving true diversity demands more than rhetoric—requiring genuine engagement, cultural humility, and a commitment to understanding and addressing the unique needs of marginalized communities.

45. SCOPE 2024: Key Takeaways From A First-Time Attendee 3/15/2024

    Sessions at SCOPE ran the industry gamut: patient-centric trial design; diversity, equity, and inclusion; AI; RWE; and much more. The common thread woven through many of these sessions? Quality data.

46. FDA Continues Diversity Push 3/15/2024

    Review the FDA's revised 2016 diversity guidance, which establishes clear expectations and standardizes recommendations for gathering and reporting race and ethnicity data.

47. Rare Disease Prioritization Model And Landscape Analysis 3/15/2024

    Uncover how a global pharmaceutical company seeking to identify promising indications among rare diseases to develop preclinical candidate molecules received an in-depth disease analysis to guide its strategic decision-making.

48. A New Era For Patient Recruitment And Retention In Rare Disease 3/15/2024

    Pharma and biotech companies prioritize innovation in areas of high and rare unmet need. Though the R&D landscape for these rare diseases can be difficult to navigate, changes are on the horizon.

49. Best Practices For Harmonizing Global Data Disclosure 2/20/2024

    Learn how sponsors can address the challenge of submitting clinical trial data in a consistent and compliant manner by examining internal processes to identify and close gaps.

50. Harnessing The Power of Real-World Data In Clinical Trial Planning 2/20/2024

    As the availability of RWD grows, it creates opportunities for sponsors to use true patient insights to support their clinical strategy and bring treatments to patients in need.