• FDA Releases New Draft Guidance on Diversity Action Plans for Clinical Studies

    Clinical Research News | Last week, the U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies. Comments on the draft guidance should be submitted by September 26, 2024.

    Jul 2, 2024

  • Follow the Money: Cholesterol-Lowering Monoclonal Antibody, Alzheimer’s Therapy, More

    Clinical Research News | Marea Therapeutics progresses their MAR001 Phase 2 development plan and further advancement of additional pipeline programs; Alzheon plans to complete their pivotal Phase 3 program and prepare commercialization of their oral Alzheimer’s therapy with runway into 2026; more.

    Jun 27, 2024

  • New SAS Clinical Products, Payment Solution from IQVIA, Certara Platform Simplifies Medical Writing, More

    Clinical Research News | SAS has expanded its portfolio to include SAS Clinical Acceleration Repository and SAS Data Maker for synthetic data; Seqster and Thread partner to accelerate access to real-world data for patients, researchers, and life science enterprises; Certara unveiled its next-generation CoAuthor regulatory writing software for medical writers; more.

    Jun 26, 2024

  • ClinEco Launches "Ask a ClinEco Luminary" Program for Expert Insights

    Clinical Research News | ClinEco has launched the "Ask a ClinEco Luminary" program, offering its members direct access to leading experts in the clinical trials industry. The initiative aims to foster progressive dialogue and provide reliable expert advice to drive meaningful discourse within the ClinEco community.

    Jun 25, 2024

  • The Seemingly ‘Wicked Problems’ Keeping Pregnant and Lactating Women From Participating in Clinical Trials Might be Fixable

    Clinical Research News | For anyone who has ever given birth, it will come as little surprise that few drugs have been approved for use during pregnancy and the breastfeeding period—even for something as basic as managing the symptoms of the cold or flu. The bigger shock may be that the absence of medicines extends to health conditions affecting pregnancy and birth such as postpartum hemorrhage and pre-eclampsia, two of the leading causes of maternal death.

    Jun 20, 2024

  • Tax Rebates ‘Icing on the Cake’ for Biotechs Doing Phase 1 Trials Down Under

    Clinical Research News | A trailblazing federally qualified health center (FQHC) in Nevada is now in the business of conducting industry-sponsored clinical trials, which may foreshadow more widespread interest among the nation’s roughly 1,400 nonprofit FQHCs enabling access to care for low‐income, racially diverse, and medically underserved populations.

    Jun 19, 2024

  • Pioneering Health Center Brings Clinical Trials to People Who Need Them Most

    Clinical Research News | A trailblazing federally qualified health center (FQHC) in Nevada is now in the business of conducting industry-sponsored clinical trials, which may foreshadow more widespread interest among the nation’s roughly 1,400 nonprofit FQHCs enabling access to care for low‐income, racially diverse, and medically underserved populations.

    Jun 18, 2024