Clinical Research

Protocol writing
Case Report Form (CRF) design
Investigations centres visits (Pre-study, Site selection, Initiation, Monitoring and Close-out)
Centralised laboratory tests*
Preparation, storage and shipment of investigational drugs*
Statistical plan preparation*
Data Management*
Statistical data analysis*
Statistical reports writing*
Integrated reports writing
Project Management
* Through a partnership


Single Opinion submissions and approvals
Local Ethic Committee submissions and approvals
Competent Authority submissions and approvals
Contracts Management
e-submission to AIFA website(CTA - preparation, submission and follow-up)
CSI, CDS and SPC writing and updating
Clinical Overview (Module 2.5)
Expert Opinions (Risk analysis)


Management of spontaneous and arising from clinical trials ICSRs (Triage, Classification, Data Entry, QC, Medical Review, Distribution/Reporting, Follow-up Requests, Final Review, Archiving)
Management of SAEs/SUSARs, Line Listing and Drug Safety Update Reports (DSUR) reporting (Mailing to ECs, CA and centers)
QPPV back-up
EV/EVCTM reporting on behalf of the Client
Pharmacovigilance back-up during Client Company closure


Clinical Data review (Investigator's Brochure)
SOPs writing and review for the Clients
Final Report writing and review