• We work on all key therapeutic areas in the
    pharmaceutical, medical device and
    diagnostic industry
  • We specialise in respiratory diseases, cardiology,
    urogenital disorders, GI disorders, neurology and nutrition
  • Specialist in Regulatory Statistics
    for Europe and North America
  • Leading experts in paediatric clinical research
  • Your Data
    Our Passion
    The data you have
    The data you plan to collect
    The data you need to submit

Your Data, Our Passion

StatisticaMedica Ltd. is a leading European clinical research organization that specialises in the design and implementation, 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

  • Gloria, Let me thank you and StatisticaMedica for the work you did for Kitov Pharmaceuticals.  Your prompt and efficient analysis of our phase 3 clinical data were essential in the successful outcome of our study.

    J. Paul Waymack M.D., Sc.D. Chairman of the Board Kitov Pharmaceuticals

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