Our experience in a wide range of

• Solid tumors and hematological diseases
• Cancer therapies (cytotoxics, cytostatics, monoclonal antibodies, vaccines, hormonal therapies,targeted therapies, nanoparticules).

Unique protocol design

• Medical/scientific input ensures study feasibility
• Real-time data evaluation in Phase I studies optimizes dose/schedule, maximizing patient safety
• Realistic Phase II-III study design (eligibility criteria, endpoints, controls, etc.)

Pharmacovigilance

• SAE reporting, narratives writing, Expedited and Periodic Safety reports, Health Authority reporting, Oracle AERS database, following FDA, ICH, EMEA PV guidelines

Clinical operations expertise

• Medical oncology input at every step
• Rigorous study execution by experienced project managers
• Quality clinical monitoring with CRAs responsible for data quality from the medical chart to the Clinical Study Report
• Oncology-trained, GCP/ICH compliant, up-to-date in the field, eCRF experience
• Medically-driven statistical analyses using validated systems (SAS®/SPSS®/Oracle Clinical®, Clintrial™)

NUVISAN Oncology also offers

• On-site medical source review by oncologists
• Database cleaning for registration trials
• Medical writing of protocols, CSRs, manuscripts, abstracts/posters, IMPD, IB
• Drug supply and distribution
• Training in oncology
• Outsourcing of personnel trained in Oncology
• Safety/Data Monitoring Committee organization

NUVISAN Oncology’s experience and expertise converts into pertinent and well executed trials with expedited approval for marketing and rapid adoption of new cancer treatments.