Ms. Shalaby has over 30 years of experience in the clinical research and drug development industry. Throughout that time,, she held several writing roles including lead author and contributing writer for investigator’s brochures (IBs), phase 2 and phase 3 clinical study reports (CSRs), investigational new drug applications (INDs), new drug applications (NDAs), study protocols, informed consent forms (ICFs), and plain language summaries (PLS). She has experience in the therapeutic areas of pediatrics, neonatology, pediatric and adult oncology, hematology, gastroenterology, pulmonary and respiratory diseases, genetic diseases, cardiology, multiple sclerosis, and rare diseases. She is the functional lead for PLS at Certara Synchrogenix.
Theresa Shalaby, MSN, RN Senior Manager, Regulatory Services