Clinical Research

Hiring New Clinical Researchers

9/17/2019

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In life, the purchase of a new car, or house, invokes feelings of excitement, potential value and sustainability.  Being new is positive thing, with infinite possibility.     

Whereas, in the clinical research industry, a new/inexperienced employee may invoke feelings of unease, and the investment of critical time and resources without prospective return. Wonderful possibility is not anticipated, rather, ability is questioned. This doubt forces the choice of experience over potential, on what is comfortable/predictable (such as the requisite two years of CRA experience for an entry level CRA position) over the unknown.

FDA Releases Draft Guidance on Inclusion of Males in Breast Cancer Trials

9/03/2019

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Male breast cancer is rare, but nonetheless as deadly as for women when at the same stage of progression. Men have been traditionally excluded from breast cancer clinical trials, so any treatment for them has been developed with data from women subjects. This results in fewer FDA approved treatment options for men with breast cancer.

Sandra “SAM” Sather at WCG/MCC Summit Sept. 4-5

8/23/2019

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What: WCG Metrics Champion Consortium (MCC) Summit

Topic: Clinical Trials Risk and Performance Management Summit Agenda

When: September 4 and 5, 2019

Where: The Loews Philadelphia Hotel; Philadelphia, PA

Book the hotel here and ask for the FDAnews rate

Registration is available here.

Live Webinar Identifying Workforce Gaps in RBM: August 13

7/30/2019

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Topic: Identifying Workforce Gaps Post Risk-Based Monitoring (RBM): It’s Time to “DIG” in!

Date: August 13, 2019

Time: 1:00 p.m. – 2:00 p.m. EDT

Duration: 60 minutes

Sponsored by: Life Science Training Institute

Webinar: Live interactive session. Recording will be available for 30 days.

Sign up here.

Introducing the DIGR-ACT® Solution! Part 6

7/09/2019

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What does ‘C’ stand for?

Do you care whether the actions you took to try to stop an issue from recurring were completed? Does it matter if they actually worked? Of course! Deciding on actions is only part way to fixing a problem. We need to complete the actions and make sure they were effective. That's why there is the ‘C’ step in the DIGR-ACT® solution, where C stands for ‘Check’.