Expert Insights On Data Management & Analysis

  1. From Data Chaos To Clarity: How To Modernize Clinical Trial Site Selection 7/19/2024

    The Pistoia Alliance introduces the ClinOps Ontology Project, an effort to establish a common language agreed upon by stakeholders across the industry to improve and standardize data collection and streamline site selection.

  2. Unveiling The Importance Of Negative Results In Clinical Trials 7/11/2024

    BJEConsultants Chief Scientific Officer Bashar S. Shihabuddin, MD discusses negative clinical trial results and how they play a role in enhancing the generalizability of research findings.

  3. Takeda Chooses Wearable To Improve Patient Experience & Data In Sleep Study 6/27/2024

    Takeda Head of the Orexin Franchise Development and Neuroscience Portfolio Strategy Elena Koundourakis explains why her team decided to pursue the use of DHTs and the benefits of doing so, for both the patients and the data accuracy. 

  4. Cell Therapies For Solid Tumors: Optimizing Your Approach To Achieve Regulatory Approval 6/19/2024

    Developing and ultimately obtaining approval of cell therapies for solid tumors requires an organized and scientifically rigorous approach. This article is a helpful road map of considerations.

  5. Beware AI Hallucinations 6/7/2024

    As the use of AI increases and expands to new functional areas within biopharmaceutical companies, leaders must understand the risks and mitigate the impact of hallucinations in AI model outputs.

  6. Medical Affairs: Unlocking Insights To Drive Innovation, Access, And Value 6/3/2024

    Medical affairs (MA) professionals are playing an increasingly dynamic, strategic role across the innovation life cycle. Astellas Pharma Executive Vice President, Head Medical Affairs Shontelle Dodson explains.

  7. Unlocking Next Generation Clinical Trials Through Data Sharing & Tech-Driven Approaches 5/21/2024

    New findings from a survey conducted in the U.S. indicate a significant number of trial participants are eager to have their data used by researchers. How can biopharma companies harness this?

  8. New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies 5/16/2024

    The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.

  9. What Can Digital Patient Twins Do For Clinical Research? 4/29/2024

    Digital patient twins have the potential to vastly improve our current healthcare systems by offering personalized therapeutics, enhanced health monitoring, and streamlined pharmaceutical manufacturing, including clinical trials.

  10. Validating A Better ALS Biomarker With Coya's Fred Grossman 4/24/2024

    Coya Therapeutics President and CMO Fred Grossman, DO, FAPA discusses a potential new biomarker for ALS — 4-HNE, an oxidative stress biomarker — and how it could be more effective than the current standard, NfL.