Danilo Uvalin

Management and oversight of clinical trials Control of scope, schedule, cost and quality including the change management Clinical operations ( from feasibility until close-out) Creation and review of key clinical documents (protocol, plans, ICFs....) Vendor selection and oversight (Co)Monitoring, sponsor oversight visits CRO selection and management, training of key personnel Risk identification and planning

Phase III General Anesthesia EU Procedural sedation: Phase III Study (Colonoscopy) USA Phase III ASA 3 & 4 patients Colonoscopy USA Phase III Study (Bronchoscopy) USA Leading the global cross functional project team of large Phase III pivotal registration studies to meet all project requirements and contribute to the company’s strategic goals.

Phase III General Anesthesia (Cardiac Surgery) trial EU Procedural sedation: 3x Phase III trials (Colonoscopy, Bronchoscopy) USA Some of responsibilities: Sponsor oversight visits. Vendor selection and oversight. Control of scope, schedule, cost and quality including the change management. Country and site selection, site performance management. Risk identification and planning of risk responses. Creation of trial specific guidelines and manuals

Phase III multinational multicenter trials: Pediatric acute pain trial (in cooperation with Janssen - Johnson & Johnson) Pediatric chronic pain trial Postoperative neuropathic pain trial

Phase IIIb Cancer pain trial - Inspection preparation initiative, review of TMF, Coordination and cooperation with different vendors (Local and central Depots, IxRS), IMP reconciliation on Study level , support during "Quality control" site visits.

Phase IIb Study in Neurology (RR-MS)

Phase III Study in Oncology (breast cancer) Phase III Study in Endocrinology(growth hormone)

Participation as a member of the Quality Assurance Unit in implementation of Good Clinical Practices (GCP). Understanding international and local requirements including: EU Directives, FDA standards, ICH - GCP requirements and national law. Development and maintenance of Standard Operating Procedures (SOPs) and Work Specific Instructions (WSIs).