Clinical Guest Contributors

  1. Improving Training In Biopharmaceutical Manufacturing
    10/19/2018

    Whether improvements in the delivery of training in biopharmaceutical manufacturing are needed is an open question, and the answers are not clear-cut. BioPlan recently conducted independent research to address this question.

  2. A Better Approach To Selecting And Overseeing GCP/GLP Vendors And Processes
    10/18/2018

    This is the third article in a series examining strategies that allow quality groups to collaborate with good clinical practice (GCP) and good manufacturing practice (GMP) divisions to improve compliance, increase clinical study robustness, and enhance data integrity.

  3. An Introduction To Financial Benchmarking In Biopharma Clinical Development
    10/16/2018

    The high cost and failure rate of new drug candidates going through clinical trials are well documented and a recurring subject of research both by industry and academia.1 Further, the cost of drug development is a debated topic, and there is no consensus on what the “true cost” is because of the different methods used for these calculations.2 The lack of adequate comparable cost data and value measures also makes it difficult for pharmaceutical sponsors and trial sites to implement financial benchmarking for planning, costing, and budget management.

  4. ClinicalTrials.gov: To Get Better Results, Talk To The Real Audience
    10/11/2018

    While controversy continues to simmer over who is accountable for posting results on ClinicalTrials.gov, perhaps the “results debate” masks the more challenging problem: ClinicalTrials.gov is not working for its intended audience.

  5. Why All The Hype Around Real-World Evidence? Here’s What You Need To Know
    10/9/2018

    This is part 2 of a two-part roundtable Q&A on real-world evidence (RWE) in the 21st century. In this installment, our experts discuss how RWE is utilized, why real-world data (RWD) analyses are getting more attention, and what the recent attention means for the future of medical practice and drug development. RWD analyses are utilized to generate insights about a medicine’s effectiveness, safety, and associated costs.

  6. R&D Data Sharing: Where We Are & Where We Need To Go
    10/4/2018

    The clinical research industry has been slow to efficiently use and repurpose data collected in clinical trials. The lack of ease, both from an ethos and technical perspective, with which pharmaceutical companies can access and share data can lead to lengthier product development, untapped study findings, and reduced collaboration between industry stakeholders. As trials become increasingly complex and costly, it is especially important to develop approaches that facilitate and encourage R&D data sharing. This not only helps clinical trial sponsors to create better informed clinical development plans and run smaller, more efficient trials, but allows patients to enroll in trials sooner and, therefore, bring innovative new therapies to the market faster.

  7. What Is Real-World Evidence, Anyway? Industry Experts Weigh In
    10/2/2018

    This is the first article in a two-part roundtable Q&A on real-world evidence (RWE) in the 21st century. In this first installment, we will explore common misconceptions surrounding real-world evidence (RWE), what should be considered to achieve good real-world data (RWD) analyses, and the impact this data can have on clinical treatment and regulatory development.

  8. 5 Major Challenges In CRO Outsourcing — And How To Overcome Them
    9/27/2018

    This is part 3 of a three-part article series on how best to procure, manage, and implement best practices in the complicated CRO market.

  9. Monitoring Adverse Event Reporting On Social Media — Should You Outsource?
    9/25/2018

    The ubiquitous nature of mobile devices means mining and monitoring social media channels and managing the challenges associated with them through technology, process management, and tactical outsourcing need to be considered standard operating procedure for clinical trials professionals and organizations.

  10. Beyond Informed Consent — How To Better Engage Millennials (And Others) In Clinical Trials
    9/20/2018

    Companies developing new healthcare products for Millennials have implemented a lot of the pieces of the puzzle of how to serve them better; unfortunately, disconnects in how those pieces link together to track the entire patient journey reduce the effectiveness of those efforts.