FEATURED CONTENT

• Deciphering The FDA's Diversity Plan Updated Guidance

  Updated FDA guidance from June outlines the format and content of Diversity Action Plans, the products and studies requiring a plan, and the submission process. Learn about the changes and what to expect.

• The Promise And Peril Of AI In Clinical Trials

  In clinical research, as with many industries, AI is met with both excitement and trepidation. The impact of AI and machine learning is starting to be felt across the pharmaceutical industry.

• Billion Dollar Blueprint: The Journey To Blockbuster Status

  The allure of a blockbuster drug lies not only in its ability to generate billions in revenue but also in its potential to spur additional R&D investment.

• 10 Ways To Set Up Your Sites For Recruitment Success

  Selecting the right trial sites is key to success. Choose sites with the right experience, patient population, diversity mix, and timelines. See these nine tips to boost recruitment and retention.

• Including Diversity At The Onset

  Designing a clinical protocol that is fit for purpose can incorporate diversity into clinical trial planning early on. Explore strategies for incorporating diversity into clinical planning and study protocols.

• Cell And Gene Therapy Field Gains Momentum

  Discover how the dynamic growth trajectory of this field underscores its potential to revolutionize medicine and deliver innovative treatments to patients worldwide.

• Completed Clinical Trials, Terminations Both Rose In 2023

  This white paper highlights how the widespread growth in completed trials is coupled with higher success rates across multiple therapeutic areas, signaling the end of pandemic-related disruptions and infectious disease-related activity after three years of fluctuations.

• Pharma R&D Review 2024: Pleasant Weather Ahead

  Gain insights from the 2024 pharma landscape, which reports a record-breaking 22,825 pipeline drugs, led by Pfizer's 32 new candidates and a strong focus on oncology and neurological treatments.

• Optimizing Recruitment For Urgently Needed Vaccine

  Uncover how Citeline Connect helped a late-stage biotech sponsor expedite enrollment of a diverse population of eligible patients impacted by monkeypox for a large Phase 1 and Phase 2 trial of a next-generation vaccine.

• Deal-Making Volume Slowed In 2023

  This report provides an overview of alliance, merger and acquisition, and financing deal activities across the global biopharma, medical device, and in vitro diagnostics industries in 2023, as reported by Biomedtracker.

• Backup Sites: The Closers Of Clinical Trials

  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.

• Pharma R&D Annual Review 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.

• Considerations For Plain Language Summaries

  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.

• Diversity In Clinical Trials: Walking The Walk

  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.

• SCOPE 2024: Key Takeaways From A First-Time Attendee

  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.

• FDA Continues Diversity Push

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

• Rare Disease Prioritization Model And Landscape Analysis

  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.

• A New Era For Patient Recruitment And Retention In Rare Disease

  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.

• Best Practices For Harmonizing Global Data Disclosure

  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.

• Harnessing The Power of Real-World Data In Clinical Trial Planning

  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.