FEATURED CONTENT

• Backup Sites: The Closers Of Clinical Trials

  With the rising complexity of trials and dwindling site availability, the adoption of backup sites has become increasingly commonplace, reflecting the industry's commitment to maximizing recruitment potential.

• 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 ultimately, advancing the collective goal of improving 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transparency and patient understanding, highlighted in the joint FDA and Office for Human Research Protections (OHRP) draft guidance.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.

• The Pharmaceutical Industry: 2024 (And Beyond) Predictions

  DCTs, RWD, IRA … our industry predictions for 2024 are filled with acronyms. As we delve into 2024, explore what trends are hot ― and not ― for the coming year, and their impact on the industry.

• Diversity In Clinical Trials: How Companies Are Tackling The Issue

  Experts from Genentech, Moderna, and Patientory share how collaborative approaches involving technology and multiple resources can improve health outcomes and increase diversity in clinical trials.

• Top 5 Insights From FDA Workshop On Enhancing Trial Diversity

  Read about how this workshop served as a reminder of the need for diversity in patient recruitment and the shared commitment across the spectrum of clinical trial stakeholders.

• Beyond KOLs: Involving All Stakeholders In The Recruitment Process

  Consider this proactive approach to patient recruitment that has the potential to ensure a more dynamic and responsive strategy, and is suited for the rapidly changing landscape of clinical trials.

• In Vivo Outlook 2024: A Health Care Metamorphosis

  Predicting the future in the biopharma realm is inherently challenging. Read this report for insights into the evolving dynamics of the healthcare and biopharma sectors in the coming year.

• Operationalizing Disclosure Intelligence For Compliance At Scale

  Learn how sponsors can transform compliance functions into unique strengths, not only meeting regulatory requirements but also uncovering strategic opportunities in this challenging landscape.

• Overcoming Burden In Patient Engagement And Recruitment

  Learn how to gauge success by addressing the challenges that patient engagement and recruitment places on sites, as well as patients.

• Drug Review Profiles: A Deep Dive Into New Drug Approvals

  Explore the dynamics behind interesting and sometimes precedent-setting new drug approvals and uncover how the regulatory process works in practice.

• Regional Comparisons Of Pharmaceutical Regulations

  Uncover how performance and regulatory expectations differ for regulatory agencies in various markets, influenced by regional drug review trends, approval decisions, and regulatory guidance.

• Phase 1-3: Clinical Trials Overview

  Various macroeconomic pressures faced by the biopharma industry led to a crunch in funding. In addition, economic and political factors contributed to a decline in clinical trials.