Nuala Ronan Email & Phone Number

Databean is a clinical stage CRO delivering clinical affairs and data management services, including EDC/CTMS solutions to med-device, bio-tech, and bio-pharma companies with lead programs in end-stage disease management, transplantation, immunology, and novel therapeutics Areas of expertise include:Business development, stakeholder relations, Class III medical device, clinical trial design and sample size justification, protocol development, contract negotiations, team training, vendor selection, site selection, subject recruitment, trial rescue, risk mitigation, electronic data management, monitoring, safety reporting, safety committee selection and management, human factors, core lab integration, QoL measures, IND/NDA and IDE/PMA/510K submissions, regulatory compliance and auditing.

V.C. backed single product start-up medical device company evaluating the safety and efficacy of an implantable drug delivery system for the treatment of chronic pain and severe neurological disease.

Independent clinical affairs consultant to academic research centers and global medical device companies

Marlton, New Jersey, Us

V.C. backed single product start-up medical device company evaluating the safety and efficacy of a predicate Class III implantable cardiac device. Recruited, trained and managed the clinical affairs and data management departments and ran day-to-day operations of a multi-center (50+ sites) global clinical trial.

Academic research organization dedicated to the design, execution and analyses of global clinical trials for innovative technology companies. Therapeutic areas of study include lung, heart, liver, kidney, and pancreatic transplant, circulatory assist devices, and disorders associated with vascular, orthopedic, pulmonary, obesity, diabetes, hematology, infectious and neurovascular disease.

Post Bac Pre Med

Bachelor'S Degree, Registered General Nursing (Rgn)