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When you’re starting a biotech or device program, everything is urgent. The pace is demanding, the challenges intimidating, and decisions have far-reaching implications.

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Functioning in an organization spanning international borders and regulatory environments means overcoming obstacles, and doing so inside the boundaries of the big picture.

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A Change is Gonna Come: Predicting the Inevitable

Featured Post from Our Thinking

Sitting in the audience of a recent conference, I could feel the anticipation building.  After listening to hours of lecture and conversation about various topics, THIS was, it seemed, the speaker that everyone was waiting for.  When the keynote stepped up to the podium, I wasn’t surprised at the anticipation that had been brewing in the room, as it was a topic that affects vendor and sponsor relationships and derails the trust that is so important in solidifying strong partnerships (see my last blog).  It was a surprise, however, to learn that all wasn’t going to be as it seemed. The topic at hand was the dreaded Change Order and how best to avoid one.  The speaker presented an unexpected twist because his primary message was that you can’t avoid it!   You could hear a pin drop in the room and feel the intake of breath as the attendees heard this expert explain that change is inevitable.  What were we all expecting?  There was no magical solution to implement, no perfect toolkit we could use that would make Change Orders fade off into the sunset, never to be heard from again.  But we already knew this didn’t we?  Was the message such a shock?  Those of us with years of experience in research (and in life) know that it is impossible to predict the future and ever-changing needs of each study team and project.  Shifts in enrollment, protocol amendments, staffing changes, task ownership are never set at the beginning of a project and stay 100% constant...

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Upcoming Events

  • Jan062015
    Webinar – Identifying And Closing The Training Gap In Clinical Research

    Halloran President and CEO, Laurie Halloran, presents a webinar, Identifying and Closing the Training Gap in Clinical Research,  in partnership with the Life Science Training Institute on January…

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  • Feb042015
    Webinar – One Size Fits All? Not for Small Sponsors and CROs

    Halloran President and CEO, Laurie Halloran, and Managing Director, Katie McCarthy, present a webinar, One Size Fits All? Not for Small Sponsors…

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  • Feb062015
    Tufts CSDD Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation

    For the third consecutive year, Halloran President and CEO, Laurie Halloran, will teach the course "How to Select and Work with…

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