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CLINICAL RESEARCH ORGANIZATION (CRO)

CORESEARCH is registered with the Italian Drug Agency (AIFA) as a Contract Research Organization (CRO) to carry out monitoring of the studies in compliance with GCP, including relations with the ethics committees for the study approval process, for statistical analysis and data management (DM 15/11/2011).

  • Planning and organization
  • Center selection
  • Investigators selection
  • Feasibility studies
  • Synopsis and protocol development
  • CRF / eCRF / Web-CRF design
  • Submission to Ethics Committees
  • Contracts
  • Submission to autorithies
  • Pre-study visits
  • Study initation visits
  • Routine monitoring visits
  • Remote electronic monitoring
  • Close-out visits
  • Centers coordination
  • Monitors coordination
  • Corrective actions
  • Studies advancement control
  • Communication to sponsors
  • Database development
  • Data entry/cleaning
  • Queries management
  • Adverse events management
  • Statistical Analysis Plan
  • Programming (SAS, R, SPSS) and datasets creation (raw & analysis)
  • Data analysis and customized reports production
  • Clinical Study Report
  • Production of scientific articles
CONTROLLED CLINICAL TRIALS
OBSERVATIONAL STUDIES / REAL WORLD DATA
SYSTEMATIC REVIEWS AND META-ANALYSES
ADVANCED STATISTICAL TECHNIQUES FOR BIOMEDICAL RESEARCH
ASSESSMENT OF QUALITY OF CARE
ASSESSMENT OF QUALITY OF LIFE
STUDIES OF NEW TECHNOLOGIES AND TELEMEDICINE FOR CHRONIC DISEASE MANAGEMENT
PHARMACOECONOMICS AND PHARMACOEPIDEMIOLOGY EVALUATIONS
ANALYSIS OF ADMINISTRATIVE DATABASES AND DISEASE REGISTRIES
SAMPLE SURVEYS