• Planning for a Successful EMA Policy 0070 Submission

    Clinical Research News | European Medicines Agency (EMA) Policy 0070 requires the proactive publishing of clinical data submitted by pharmaceutical companies to support their marketing applications for human medicines under the centralized procedure. In other words, the EMA will publish anonymized documentation (with sensitive participant and company data protected) supporting the use of a drug on its public Clinical Data website so that anyone can read about medicines being authorized.

    Dec 15, 2023

  • Pharma’s Tech Partner Wish List

    Clinical Research News | What is pharma looking for in technology partners? That was the question posed to a panel representing Pfizer, Johnson & Johnson, GlaxoSmithKline, and AstraZeneca last month at the HLTH Conference. The answers revealed some of the trends these pharma companies expect to see in drug development and clinical trials, and the pain points they are actively addressing now.

    Dec 14, 2023

  • Participant Engagement Award Finalists Named for 2024

    Clinical Research News | The judges have announced the finalists for the annual Participant Engagement Award that is awarded each year at SCOPE, the Summit for Clinical Ops Executives. In 2024, entries from Acclinate, CISCRP, IMA Clinical Research, Oliver Patch Project, PatientWing, and SGM Alliance have progressed to the final round of consideration. The winner will be named after a live judging session with audience participation in Orlando, February 11-14.

    Dec 12, 2023

  • Navigating Cell Therapy Clinical Trial Budgets: Proactive Strategies for Success

    Clinical Research News | Clinical trial sponsors must strike a balance between budget, speed, and data quality when planning for cell therapy clinical trial costs. These costs can be difficult to predict and budget overruns often happen. However, cell therapy sponsors can better plan for clinical trial costs and lower their risk of exceeding their budgets by taking specific steps early on.

    Dec 8, 2023

  • Colleen Tenan on Respect and Mindfulness During Patient Treatment

    Clinical Research News | Clinical trials can lead to breakthroughs in research, but they can also be a viable and beneficial care option for patients. According to Colleen Purcell Tenan, M.D., medical director at Javara, clinical trials can offer resources that many patients do not have access to, such as medications not covered by insurance, counseling, and close medical follow-up.

    Dec 7, 2023

  • Prevention Strategy For Alzheimer’s Disease Now On The Horizon

    Clinical Research News | It may be possible one day soon to prevent Alzheimer’s disease, a devastating illness currently suffered by more than 30 million people worldwide. The good news comes straight from the mouth of Randall J. Bateman, M.D., professor of neurology at Washington University School of Medicine and director of the Dominantly Inherited Alzheimer Network (DIAN) and DIAN Trials Unit (DIAN-TU).

    Dec 6, 2023