PhD
Clinical / Scientific Research & Medical Writing
Dr. Eeke Romo was born and raised in the Netherlands where she received her medical doctorate degree. In pursuit of required research activities, Dr. Romo worked as a research associate for California State Developmental Research Institute in Costa Mesa and for the Department of Psychiatry and Human Behavior at the University of California, Irvine (UCI).
While applying for a doctoral program at UCI, Dr. Romo was offered a postdoctoral position in Psychobiology. She spent the next 2 1/2 years laying her foundations of basic research, research methodologies and scientific writing including manuscript preparation. Concurrent coordination of drug trials at the Alzheimer’s Disease Diagnostic and Research Center peaked her interest of applied science in the medical device industry.
During the following four years, Dr. Romo was employed at the Clinical Affairs Department of Baxter Healthcare Corporation, Edwards CVS Division where she held several positions with increasing responsibilities.
The cumulating experience led to the position of Director of Clinical Affairs at TheraCardia Inc., a start-up company focused on a novel class III device used in Emergency Medicine. Here for the next 2 years, Dr. Romo established the Clinical Affairs department; developed clinical strategies, protocols and CRFs for all study phases; managed local and international CRAs and CROs was responsible for training and training materials; recruited investigators and performed pre-study, study initiation, and monitoring visits.
In August 2000, Dr. Romo became a full-time clinical/scientific research consultant and medical writer. Dr. Romo’s proficiencies include, but are not limited to, preparation of clinical, pre-clinical, annual, and clinical reports for numerous successful PMA submissions, IDE and IND submissions; preparation of briefing materials for advisory panels; protocol and CRF development for (novel) devices, pharmaceuticals, biologics and drug studies; development of training materials; preparation of Clinical Investigator Brochures; extensive literature reviews for regulatory submissions; preparation and submission of IRB/IBC/EC applications; preparation of manuscripts for submission to peer-reviewed journals. In her role as Medical Director with MedTech, Dr. Romo has overseen the conduct of three gene therapy studies, a cerebral vasospasm study, and an EUA study involving COVID-19 patients.
For more information, please contact Dr. Romo at eekeromo@cox.net or eeke@biomdg.com