Services – Armando Cimbi

I offer Clinical Programming and Statistical Support in Clinical Research and Development Phase as well as Post-Marketing Phase across Various Therapeutic Areas

Clinical Research

I have supported Clinical Studies since 2002 as a Statistical Programmer and have also been involved in Several Submissions for FDA, EMA and PMDA

Statistical Programming

I can provide Statistical Solutions and Expertise for Supporting Planning, Design and Analysis of Clinical Trials offering a Variety of Services

Biostatistics

I offer Statistical Support for Clinical Research / Development Phase and “Post-Marketing” Phase:

Phase I-IV Clinical Trials
NIS / PASS Studies
Thorough QT / QTc Trials
HTA Trials

Including a Broad Range of Clinical Statistical Services:

Statistical Input into Study Protocols
Sample Size / Power Calculation
Statistical Analysis Plan (SAP)
Preparation of TFL (Tables, Figures, Listings) Shell for Clinical Trial Reports according to ICH Guidelines
Statistical Analysis Interpretation
Pharmocokinetics (PK) / Pharmacodynamics (PD) Analysis
Interim Analysis
Meta Analysis
HTA Analysis (Subpopulations, Subgroups, Heterogeneity Tests)
Statistical Exploratory Analysis for Publications, Abstracts, and Manuscripts

As well as Statistical Programming:

Analysis Datasets
CDISC (SDTM and ADaM)
Tables, Figures, Listings
Production of SAS Macros
Statistical Program Validation
Confirming Statistical Tests and Ad-hoc Reports with SAS

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