futurpositif

Clinical Operations | Digital Frontiers | Patient Focus

Category: Uncategorized

  • Project Governance – where to look for Root Causes

    Scenario: Your pivotal clinical trial is far behind schedule.  Although CTA (Clinical Trial Application) approvals are beginning to come in, site activations are proving difficult to schedule at sites, you’ve discovered that one of your key vendors will have difficulties delivering devices to sites on time and your study managers inform you that the CRO…

  • Let’s make clinical trial technical vendors part of the (training) solution.

    One of the factors driving the burden of clinical trials is the number and complexity of instruments (including equipment, software or other devices) needed to measure study endpoints.  Each of these instruments requires proper set-up and calibration at the study site, staff training and sometimes user certification to make sure the assessments are valid and…

  • What’s so hard about patient centricity in clinical trials?

    There’s a lot of talk about customer centricity and patient centricity in the pharma industry these days.  The discussion extends to drug development and clinical trials. This started a few years ago, as we realized that our clinical trials were getting more and more difficult for patients due to the number of assessments and the…

  • How to think about Training – three levels to Mastery

    A few years ago, I led a team trying to organize a massive training challenge.  We were changing the way we employed some of our key project personnel around the globe.  It was a change that would impact nearly 1,100 professionals working on more than 300 projects.  There was a significant risk that people would…

  • Leadership is a Responsibility

    For a company video interview a few years ago, I was asked if I have a “leadership philosophy.”  The question caught me a little off guard and my first answer was a quick “no.”  About a minute later I realized that I do have a couple of consistent expectations that I try to live by. …

  • The Journey Begins

    Good company in a journey makes the way seem shorter. — Izaak Walton Thanks for joining me! So the text above (and the photo) are courtesy of WordPress.  But they both seem appropriate.