Pre-study activities
Pre-study activites
Trial Planning
Sites & Investigators Selection
Feasibility Study
Synopsis and Protocol Development
CRF Design
Start-up activities
Start-up activities
Submission in CTIS
Contract Finalization
Project Management
Project Management
Sites Coordination
Monitors Coordination
Proposal of corrective actions
Check of study progress
Periodic updates to Sponsor
Study plans development
Monitoring
Monitoring
On-site Pre-study visits
On-site Study Initiation Visits
On-site Monitoring Visits
On-site Close-out visits
Off-sites visits (all types)
Centralized monitoring
Data Management & Statistics
Data Management & Statistics
Data Base Development
_____LB eCRF “Evidence” GAMP 5 validated
_____ePROs
_____Paper CRF
Data-entry
Data Cleaning & Query resolution
Coding
Sample size calculation and methods
Statistical Analysis Plan (SAP)
Statistical Analysis and reports
Other Services
Other Services
Medical Writing
Medical Monitoring
Telemedicine
Patients engagement
Virtual Clinical Trials
Narrative Medicine
Pharmacoeconomic Analysis
Central LAB management
Drug Supply and Packaging Management