10 years of providing first-class biostatistical support to optimise your product-to-market success
Statistica Medica – World class biostatistics and clinical research organisation
We work on all key therapeutic areas in the pharmaceutical, medical device and diagnostic industry
We specialize in respiratory diseases, cardiology, urogenital disorders, GI disorders, neurology and nutrition
Leading experts in Regulatory Statistics for Europe and North America. We maximise the use of regulatory-grade biostatistics for effective FDA, EMA, MDR and IVDR submissions
Leading experts in pediatric clinical research
Your data
Our Passion
The data you have
The data you plan to collect
The data you need to submit
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Your Data, Our Passion

StatisticaMedica Ltd. is a leading European clinical research organization that specialises in the design, analysis and reporting of clinical trials in the  pharmaceutical, medical device, diagnostics, food and healthcare industries. 

We work with the full spectrum of industry players, startups, SMEs, large pharma/biotech – and also with academic institutions and research organizations worldwide.

Our team of biostatisticians, , survey methodologists, health economists,bioinformaticians, clinical data managers, medical writers, regulatory experts and IT developers have a unique blend of experience and expertise which helps our clients to improve the “licensability” and “approvability” of their products by shaping and collating data in the format required by major industry players and regulatory bodies.

The company is a young and thriving environment where statistics, mathematics, medicine, data science, pharmaceutical science, bioengineering and computing co-exist and merge at all levels of applied research.

What we do

Design

Study Design, Adaptive Design, Protocol Writing, SAP, 
DMP, Sample Size Calculation, Sampling Methods, 
Questionnaire/CRF Design, Database Design

Analysis

Statistical Analysis, Bioinformatics, ‘Omic’ analysis,
Data interpretation, Statistical Programming, in SAS and R, Tables, Figures and Listings, compliant with ICH guidelines

Output

Proof of Concept, Regulatory Submissions support throughout the whole study process,
ICH compliant Clinical Study Reports, Commercialization strategy developement,
Publications, Policy Documents, Methodological Research

Testimonials

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