Get to know us better

A few things about our company

StatisticaMedica was established in 2011 and has experienced rapid growth ever since, building its team of statisticians, bioinformaticians, clinical data managers, medical writers and regulatory experts as well as establishing an extensive network of clinicians, collaborations with research institutes and specialist partner organizations across Europe and the US.

Headquartered in Ireland and led by our CEO, Dr. Gloria Crispino, StatisticaMedica has extensive knowledge, experience and exposure to the complexities and nuances of the various health environments across Europe and North America. We focus on enhancing the quality of the data to support the effective delivery of results through each step of the development process, from bench work to clinical trials and observational studies.

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

How we do it?

We provide a comprehensive suite of value–added services to the pharmaceutical, medical device, diagnostics, healthcare, food sectors in industry and academia which enable us to:


  • Interpret existing data and extract valuable insights.

  • Design studies that offer measurable answers to concrete research questions.

  • Improve the “licensability” and approvability” of products by shaping and collating data in the format required by major industry players and regulatory bodies.

  • Manage the interaction with the regulatory bodies effectively and provide innovative solutions which address their concerns.

  • Complement other ‘partner activities’ of the studies, including project management and regulatory.

  • Provide access to our broad network of medical consultants who can add intellectual value and facilitate the scale-up of early studies.

Biostatistics

Dr. Gloria Crispino – CEO and Director of Biostatistics
Biostatistics

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Eoghan O’Brien, MSc - Biostatistician
Biostatistics

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Dr. Tim Grant, PhD - Consultant Biostatistician
Biostatistics

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Anna Pozzebon, MSc - Biostatistician
Biostatistics

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Stefano Renzetti, MSc - Biostatistician
Biostatistics

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Scientific Advisors

Prof. Carlos Blanco – Scientific Advisor
Scientific Advisors

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Data Management and Data Quality

Olga Sazenova, MSc - Clinical Data Manager
Data Management and Data Quality

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Yen Phan, MSc – Data Scientist
Data Management and Data Quality

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John O’Brien, PhD – Bioinformatics
Data Management and Data Quality

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Cesare Faini – IT Developer
Data Management and Data Quality

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Hermes Collini – IT Developer
Data Management and Data Quality

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Medical Writing

Laura Williams, BSc - Medical Writer consultant
Medical Writing

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Brigitte Scott, BSc - Medical Writer consultant
Medical Writing

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Regulatory and Clinical Operations

Marie Mellody, MSc – Regulatory and Clinical Operations consultant
Regulatory and Clinical Operations

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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