Clinical Guest Contributors

  1. R&D Data Sharing: Where We Are & Where We Need To Go

    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.

  2. What Is Real-World Evidence, Anyway? Industry Experts Weigh In

    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.

  3. 5 Major Challenges In CRO Outsourcing — And How To Overcome Them

    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.

  4. Monitoring Adverse Event Reporting On Social Media — Should You Outsource?

    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.

  5. Beyond Informed Consent — How To Better Engage Millennials (And Others) In Clinical Trials

    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.

  6. How Novartis Developed An Agile Approach To Rapid Study Startup

    Over the last four years, the U.S. Medical Operations group of Novartis Oncology — in collaboration with internal clinical partners — has been transforming the study startup process for Novartis-sponsored studies.

  7. Clinical Trial Networks: Overcoming The Complexities Of Regenerative Medicine Studies

    The FDA’s RMAT and breakthrough designations have created a streamlined environment for product sponsors. To effectively leverage this regulatory policy environment, sponsors must conduct high-quality clinical trials that are often operationally complex. Clinical trial networks, capable of managing the array of regenerative medicine technologies, are well suited to manage this complexity.

  8. 5 GCP Compliance Mistakes To Avoid With Job Descriptions, CVs, & Org Charts

    When it comes to GCP audits and inspections, low-hanging fruit says a lot about the tree.

  9. How To Spot Fake CRA Candidates — Before Scheduling An Interview

    An overview of current trends and a few pointers that will considerably improve your ability to identify candidate fraudulence early in the recruitment process.

  10. The Benefits Of Real-World Evidence (RWE) For Biosimilars And Special Populations

    While RWE can serve as a key complement to clinical studies in the development of a wide range of therapies, there are specific instances for which RWE is particularly beneficial and indeed the only available evidence to support regulatory approval. RWE has the potential to spur the uptake of biosimilars in the U.S. market and to provide information on a drug’s efficacy and safety in special populations that may otherwise be excluded from clinical trial studies.