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Ms.
Earabino will provide consulting services within the areas of
scientific and regulatory aspects of clinical trials, and medical
writing. She has an extensive clinical background across
multiple therapeutic areas and has significant clinical trials
experience, including complete site management of clinical trials at
a major medical center and project management at industry leading
CROs.
This
experience includes managing several phase one, two and three
clinical trials. Her experience extends across both
clinical and scientific areas, including working on preclinical and
clinical research projects, monitoring trials, conducting site
reviews, data collection and safety reporting to sponsors and the
FDA.
Other experience includes communicating and working
with institutional Internal Review boards on all aspects of trial
oversight, and new protocol development. She is also able to
assist with protocol review/development, editing of source
documentation and assisting in safely reporting and data collection.
Ms.
Earabino has worked with several major CRO's including PPD and
Quintiles and for various academic research institutions including
Johns Hopkins, Duke University Medical Center and the US Government
Public Health Service.
She
has a BA in Biology and Environmental Science from New England
College, and a BS in Nursing from Johns Hopkins University.
Ms.
Earabino skills would be particularly useful to any company involved
in or needing help in designing clinical trials involving humans,
especially trials involving new drugs or new diagnostics. In
addition she can assist companies in compiling existing data and
document auditing prior to a FDA submission.
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