Ronni Spanola
Ronni has over 15 years of experience in clinical research, particularly in supporting bioequivalence and Phase I-IV trials. Her clinical expertise spans a range of areas, including hypertension, Alzheimer’s disease, asthma, depression, diabetes, hepatitis C (HCV), schizophrenia, major depressive disorder, and allergic diseases.
Her expertise in study design encompasses various aspects, such as pharmacokinetics/pharmacodynamics (PK/PD) sampling, first-in-human studies, food effect assessments, drug-drug interaction studies, single and multiple ascending dose studies, renal impairment research, and medical device trials.
Ronni is proficient in multiple dosing routes, including oral, inhalation, intraocular, intramuscular injection, intravenous injection, and transdermal drug delivery. She effectively communicates with Principal Investigators, sponsors, managers, Scientific Directors, and study coordinators to ensure that all aspects of the protocol and study requirements are clearly understood before the start of any clinical research. Additionally, Ronni often assists in the design, implementation, and coordination of data collection, source documentation, and case report form (CRF) transcription, all in compliance with protocols, standard operating procedures (SOPs), and ICH/GCP guidelines.