Clinical Guest Contributors

  1. Does The First-Patient-In Milestone Really Matter?

    Sorry, pharma executives. We have all been duped for years that the FPI milestone yields an increase in stock price and company value.

  2. Consolidation In The Core Lab Market — What Pharma Companies Need To Know

    Clinical laboratory services are the most outsourced services by pharmaceutical, biopharmaceutical, and medical device companies. Trending in the central or core laboratory services market is consolidation and integration of services through acquisitions and collaborations inorganically to expand beyond core services. Through horizontal integration suppliers increase their market share.

  3. Why Staff-Centricity Needs To Be Front And Center On Your Radar In 2018

    As 2017 comes to an end, I have been reflecting on the topics I’ve covered this year, focused mainly on patient- and site-centricity.  It occurred to me that as an industry, we’ve been missing the topic of staff-centricity for quite some time.  Patient engagement officers and related roles are becoming more commonplace, and many service providers have a variety of personnel focused on customer engagement.  But it’s rarer to hear about employee engagement officers. 

  4. Best Practices For Managing Clinical Supply Inventory

    It is critical to maintain patients on drug supplies during clinical trials, both for the success of the study and for the health of the patient. In this second part of this series on ensuring adequate drug supply, we will look at some specific strategies for successfully managing the clinical supply inventory.

  5. A Critical Juncture For Clinical Trial Data Management

    Data management functions are managing a much higher volume and diversity of data in response to the increasing scope and demands of global drug development programs. Real-world data and evidence, electronic clinical outcome assessments, data from smartphones and mobile devices, social media community data, and electronic health/medical records are examples of the variety of new data sources now captured during a clinical trial.  The volume and diversity of data presents integration, compatibility, and interoperability challenges that must be optimized to improve drug development performance and efficiency.

  6. Rare Diseases Require Unique Approaches In Clinical Trial Design

    The vast majority of rare diseases have no approved treatments available, despite the fact that research related to these diseases has expanded significantly in the past 20 years. A key reason may be the many unique challenges researchers face when developing drugs to treat rare diseases, including difficulties designing and executing effective and appropriate clinical trials.

  7. FDA Draft Guidance On Electronic Records And Signatures: The Next Chapter

    The FDA has released a Draft Guidance titled Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers. Certainly, the development of this draft guidance was driven by the repetitious questions the FDA has received from industry stakeholders as well as the extensive technology advancements.

  8. How Amazon Could Disrupt The CRO Model

    Based on Amazon's approach to building its business, it is logical to conclude that the online retailer would be an amazing CRO. Amazon’s competitive strategy is to aggressively discount prices to win market share. Plus, its customer obsession and disruptive innovation are second to none. Let’s imagine what an Amazon-run CRO would look like.

  9. Plan Ahead To Mitigate Post-Study Conflicts

    Recently, a pharmaceutical executive raised an interesting question in the media. To paraphrase, he asked, “What should a corporate entity do when it has new information that is material to its financial situation and that new information is ‘under embargo’ until it is either published in a journal or presented at a scientific meeting?”

  10. How To Conduct More Efficient Clinical Trials Using Registries

    Integrating clinical trials within registries offers several opportunities: avoiding duplicative data collection, identifying and recruiting patients more efficiently, and accelerating decision making, to name a few. These efficiencies have the potential to reduce clinical trial costs — especially when a registry is used to conduct multiple clinical trials.