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

The advice is invaluable, providing clear thought provoking guidance in the design of studies as well as in the interpretation of results
Professor of Respiratory Medicine, Beaumont Hospital, Dublin Ireland
StatisticaMedica has provided our research group with invaluable guidance and assistance with our varied projects, from randomised controlled trials through to biomedical research. We have benefited fundamentally by seeking their input at the conceptual stages of our research, because they offer far more than basic statistical support – our research design, methodology and, indeed, the strategic development of our group has been augmented by our association with StatisticaMedica.
Prof. of Paediatric Emergency Medicine, Cork University Hospital, Ireland
StatisticaMedica have provided extensive expertise in clinical investigation planning including selection of study variables, inclusion/exclusion criteria and SOP development. They have provided tailored in house training on clinical investigation plan design and execution in accordance with OECD GLP and ISO 14155 guidelines. StatisticaMedica continues to be a vital resource for our company. StatisticaMedica are a responsive, well-informed statistical consultancy solution
Clinical Research Manager, Medical Device Company, UK
StatisticaMedica provides added value with their in-depth knowledge of the European clinical market, clinical study design and statistics and their network of Irish and European experts
Centre Director from a leading Research Institute, USA
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Recent News

MDR: It’s Not the End of the World for Medtech Companies
StatisticaMedica A Catalyst For Medical Breakthorughs
StatisticaMedica starts their 100th project! From a small start-up to an international player.
We speak the same language - "StatisticaMedica is now a Member of CDISC"
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