For Robin’s pharmaceutical clients, her 10 years of industry experience is invaluable. She has served on the front line as an independent monitor and auditor and deep in the trenches as a project manager, program developer, consultant to marketing and discovery, and attendant at FDA meetings. She has consulted on study design issues, study site selection and international study management.

Robin prepares a wide variety of documents for her medical writing clients. She has written protocols and protocol amendments, regulatory submissions for FDA Annual Reports, NDAs and INDS, end of study reports, SAE narratives, investigator brochures, manuscripts, abstracts, and corporate SOPs. She has also created study specific documents (informed consent forms, study manuals, case report forms, study monitoring manuals, etc.)

Robin has a B.Ph. in BioPhysics and a B.A. in Physics from Miami University in Oxford, Ohio. She has completed a variety of client-specific training including ICH, GCP, OSHA, and HIPAA training.

View some of Robin's work on the Articles and Essays page.

   



 
 
 
 
 
designed by Goodfriend Solutions