Ronni Spanola has over 15 years of experience in clinical research, particularly in supporting single and multiple ascending dose, food effect, drug interaction, and bioequivalence trials. She has expertise in the management of phase 1 kinetic-dynamic studies that assess the pharmacodynamic effects o CNS drugs using biomarkers.
Ronni is experienced with multiple dosing formulations, including oral, inhalation, intraocular, intramuscular injection, intravenous injection, and transdermal drug delivery. She effectively communicates with principal investigators, sponsors, managers, scientific advisors, and study coordinators to ensure that all aspects of the protocol and study requirements are clearly understood before the start of clinical research activity. 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.
