SERVICES

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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

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Regulatory

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)

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Pharmacovigilance

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

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Other

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