Home     Consultants     Deborah J. Porter

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(formerly the Philadelphia College of Pharmacy and Science).

Ms. Porter's background is particularly useful to clients seeking clinical trials development.