Clinical Guest Contributors

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. The Time Is Now To Professionalize The Clinical Trial Workforce

    Donna was the office manager for a trucking company. Terri worked at the reception desk of a contract research organization (CRO) straight out of high school. Tom lost his job teaching history at a community college after a round of layoffs. Jessica earned her living at a local hair salon.

  9. Precise Patient Recruitment Planning – It’s All About The Patient Pathway

    At this stage in my career, I confess that I’ve lost track of the number of publications and presentations I’ve developed and delivered on the topic of patient recruitment. Many of these have focused on lessons learned from troubleshooting hundreds of trials in “rescue mode.” As I reflect on why so many recruitment campaigns or efforts fail to deliver the expected results, a common root cause issue points to the lack of understanding of the importance of, and how to create, a meaningful patient pathway. This terminology may mean different things to different individuals and organizations and may be used interchangeably with patient journeys.

  10. Initiating Multinational Clinical Trials: Major Differences Between The U.S. And EU

    There are significant differences between the U.S. and the EU with respect to the process of gaining regulatory approvals for initiating clinical trials of a new (unapproved) medication. Those differences relate to the initial regulatory submission, review, and approval process and the process for obtaining institutional review board / central ethics committee approval to initiate the clinical trial.