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Ms. Porter provides consulting
services in scientific and regulatory aspects of clinical
research with an emphasis on pharmaceutical sponsored clinical
trials, and an expertise in the area of Title 21- Code of Federal
Regulations (CFR) Parts 50, 54, 56 & 312 and the ICH Guidelines
for Good Clinical Practice (GCPs), as adopted by the FDA.
Ms. Porter has over 10 years
industry experience, either in an employee or consultant capacity,
with major pharmaceutical companies (including Pfizer,
Astra Zeneca, & Eli
Lilly & Co.) Ms. Porter also carries the credentials of Certified Clinical
Research Associate by the Association
of Clinical Research Professionals (ACRP).
Ms. Porter’s extensive
professional experience includes writing Investigational Protocols
and study documents (i.e. Informed Consent Forms, Case Report Forms,
Source Documents & Training Materials).
Additionally, she has experience with Investigator, Vendor
& Clinical Research Associate (CRA) selection & training;
and her major area of expertise lies in clinical trials project
management and clinical trials education.
Ms.
Porter has BA Degrees (Financial Economics & Counseling
Psychology) from Moravian College,
a MA Degree (Counseling Psychology) from Immaculata
University (formerly Immaculata College) and a MS Degree
in Biomedical Writing from the University
of Sciences in Philadelphia (formerly the Philadelphia College
of Pharmacy and Science).
Ms.
Porter’s background is particularly useful to clients
seeking clinical trials development
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