Central Laboratories Featured Articles

  1. Future Funding, Trial Success Necessitates Use Of AI 10/12/2023

    Integrating AI enables sponsors to design better clinical trials, researchers to refine their subjects more effectively, and investors to allocate resources more productively. Here, Garri Zmudze discusses implications for AI in clinical research and how funding will follow its integration.

  2. Opportunities For AI To Assist Cell & Gene Therapy Companies 10/10/2023

    Although AI/ML is still in a nascent stage in the cell and gene therapy sector, it has an enormous amount of potential to transform overall business models, early R&D, clinical trials, manufacturing and operations, and regulatory compliance support in these key ways.

  3. Secondary Use Of Primary Health Data In A Clinical Trials Digital Revolution 10/6/2023

    LongeVC managing partner Sergey Jakimov discusses how primary health data, when synergized with cutting-edge digital solutions, is set to revolutionize clinical research.

  4. Patients Need Faster Access To Approved FDA Vaccines. What Can We Do? 8/17/2023

    There are times when a significant lag between the FDA approval of vaccines and the Centers for Disease Control and Prevention (CDC) recommendation of those vaccines throws any newly approved vaccines into patient access purgatory. What can vaccine developers do during the clinical trial phase, and what can other stakeholders do, to help influence a shorter lag?

  5. AI's Potential To Improve Clinical Operations, Trial Matching 8/11/2023

    Microsoft's Dr. Hoifung Poon explains how AI (specifically, large language models) can be used to improve patient care and clinical workflows by making it easier to match patients to trials.

  6. How Blockchain Can Empower Patients And Improve Clinical Trials 8/4/2023

    Blockchain is far bigger than cryptocurrency. It's a data encryption technology that can not only strengthen existing clinical systems, but also (and most importantly) empower patients by giving them more control and ownership of their clinical data.

  7. How Can Non-randomized RWE Studies Complement RCTs? 8/4/2023

    While RWE can provide deep insights into the drug development process, inform regulatory decisions, and supplement clinical research, it does have its limitations. Researchers with the RCT-DUPLICATE Initiative have emerged with key learnings to further inform the industry on the capabilities of RWE.

  8. Designing Quality Into Your TMF: ICH E6(R3) And Advancing Trial Efficiency 7/17/2023

    The May release of the International Council for Harmonization (ICH) draft guidance E6(R3) for public review and comment has inspired optimism that its implementation could lead to more efficient trials. Could implementation also improve trial master file (TMF) quality in support of greater efficiency?

  9. No More XPT? Piloting New Dataset-JSON For FDA Submissions 7/12/2023

    CDISC has developed Dataset-JSON, a new dataset exchange format, to replace XPT. Working with the FDA and industry participants, CDISC and PHUSE are leading a new pilot project to test Dataset-JSON for use in regulatory submissions as well as other dataset exchange scenarios.

  10. Key Takeaways From The EU MDR Expert Panels' First Published Scientific Opinions 7/10/2023

    The EU's Medical Device Regulation, which entered into force in 2021, introduced new requirements for clinical and post-market data for medical devices in Europe. As an additional level of scrutiny for specific devices, the Clinical Evaluation Consultation Procedure ensures that notified bodies correctly assess the clinical data. Let's look at what we can learn from the expert panels' first published scientific opinions.