Central Laboratories Featured Articles

  1. Shared Knowledge & Shared Data Is Crucial To Developing Innovative Therapies For SCIs 7/7/2023

    In this Q&A, Chief Science Officer Marco Baptista, Ph.D., discusses the Christopher & Dana Reeve Foundation's focus on and approach to data and knowledge sharing, as well as patient engagement, as it works to advocate for and fund the development of spinal cord injury (SCI) therapeutics.

  2. Using RWD For Rapid Signal Assessment: Current Gaps And Opportunities 6/23/2023

    One of the chief benefits of applying RWD for rapid signal assessment is that it can provide a more accurate view of outcomes that should be expected within a given clinical scenario. However, before RWD’s maximum potential for rapid signal assessment can be reached, the industry must overcome some sizable challenges. Amgen's Vaishali Patadia explains.

  3. Safety-centric Monitoring: Measuring Safety Data In A Consistent And Standardized Manner 6/19/2023

    Today, we have access to more data than ever before, and in an ever-advancing technological landscape, it is increasingly important to adopt a safety-centric monitoring approach that ensures we can measure safety data in real time and in a standardized manner across the industry. The challenge now is how to extract and leverage the quality data from the large volume that we have access to.

  4. BIO 2023 Takeaways: AI, Accelerated Approval, Patient Diversity 6/15/2023

    On the heels of what felt like the biggest BIO International Convention in years, we’ve compiled a handful of impressions from attendees representing small and mid-size biotech/pharmas, consultancies, and professional organizations.

  5. FDA Seeks Input On AI Adoption In Drug Development And Manufacture 6/13/2023

    The FDA released two discussion papers for consideration: Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products and Artificial Intelligence in Drug Manufacturing. The papers identify current and potential areas for AI adoption.

  6. A Practical Look At Data Governance In The Life Sciences 6/13/2023

    Without solid data governance, there is an increased risk of data discrepancies, misinterpretation, or even loss, which can hamper the development process. But what exactly is data governance? This expert shares a handy list of key considerations and strategies for moving forward.

  7. Tapping Into AI/ML Partnerships To Advance Drug Discovery With Recursion Pharma 6/8/2023

    "TechBio" company Recursion Pharma has entered agreements to acquire AI/ML company Cyclica for $40 million and Valence for $47.5 million. To learn about the acquisitions and the future of AI/ML in drug discovery and development, we caught up with Recursion’s CEO Chris Gibson.

  8. How Do You Determine If RWE Is A Good Fit For Your Org? Ask (And Answer) The Right Questions 6/5/2023

    Real world evidence (RWE) is being heralded as a way to enrich our clinical data and lower the barriers to reimbursement. It also carries the potential of reducing the patient burden and lowering the cost of clinical data acquisition. But before getting to the point where we can reap the promises of RWE, we face a number of challenges as an industry. 

  9. Considerations For Compliance With CTIS Submissions Under The EU-CTR 5/31/2023

    This article outlines the process for sponsors in transitioning from an EU-CTD to an EU-CTR CTIS submission process. It provides guidance on redacting both personal data and confidential commercial information (CCI) appropriately, with detailed advice on how to identify and assess CCI for redaction, as well as strategies for minimizing the risk.

  10. From Big Pharma To Nonprofit: 3 Learnings In Building Biostatistics++ Teams 5/19/2023

    Biostatistics++ teams involve data management, programming, bioinformatics, epidemiology, and medical writing, and they have a unique position in clinical research and clinical trials. This expert offers advice based on her experience of more than two decades building biostatistics++ teams for Big Pharma, small biotech, and nonprofit orgs.