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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10 years of providing first class biostatistical support to clinical research

We work on all key therapeutic areas in the pharmaceutical, medical device and diagnostic industry

We have experience in a variety of therapeutic areas, including cardiovascular, respiratory, neurology, oncology, dermatology, urology, and have processes in place to expand to any therapeutic area

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

Your Data, Our Passion

StatisticaMedica is a leading biostatistical and high-level strategic consulting clinical research organisation committed to guiding you throughout the drug development process. We specialise in the design, data analysis and reporting of clinical trials in the global pharmaceutical, medical device and healthcare industries, and academia. Founded in Dublin, Ireland in 2012, and with teams in Ireland, Italy and the UK, StatisticaMedica provides first-class biostatistical support, underpinned by our core values of integrity, consistency and exceptional quality.

Understanding the mindset of the regulatory statisticians

StatisticaMedica interacts directly with the FDA/regulatory body for regulatory submissions on our client’s behalf. Our insight into the regulatory biostatisticians’ requirements results in significantly reduced review times and minimises any FDA questions on the data.

Our mission

Our mission is to provide first-class biostatistical support, expertise, analysis and consultancy in partnership with our clients to ensure robustness of concept, quality of data, and validity of product claims, and to guide towards a successful clinical trial submission.

Featured Services

We provide first-class support, expertise, analysis and consultancy in the following key areas:

Biostatistics Services

Comprehensive, high-quality biostatistics services for the success of your clinical trial

Clinical Trial Design Services

Innovative and effective approaches to clinical trial design, providing clear, measurable answers to design and strategy questions

CDISC Services

Consistent delivery of high-quality, CDISC-submission-ready data

Biostatistical Advisory and Consultancy Services

High-level advisory and consulting services to optimise your clinical development strategy

Medical Writing Services

Specialist services and expertise in Medical Writing to support your regulatory submission

Data Management Services

To be added

Biostatistics Services

Comprehensive, high-quality biostatistics services for the success of your clinical trial

Read more

Clinical Trial Design Services

Innovative and effective approaches to clinical trial design

Read more

CDISC Services

Consistent delivery of high-quality, CDISC-submission-ready data

Read more

Biostatistical Advisory and Consultancy Services

High-level advisory and consulting services

Read more

Medical Writing Services

Specialist services and expertise in Medical Writing to support your regulatory submission

Read more

Data Management Services

Complementary data management services in addition to our core biostatistics

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Testimonials

Clinical Research Manager, Medical Device Company, UK

“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.”

Testimonials

The first-class biostatistical support we provide enables our clients to accelerate the product authorisation process and enhances product-to-market success.

Resources

Here we provide our latest articles, podcasts and industry communications: Insights and expertise you can trust

StatisticaMedica has the expertise to provide

One of StatisticaMedica’s core services is to provide Statistical Consulting to Optimise Clinical Development Strategies The value of this service is particularly evident…

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MDR: It’s Not the End of the World for Medtech Companies

One of StatisticaMedica’s core services is to provideStatistical Consulting to Optimise Clinical Development Strategies  The value of this service is...

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Meet the StatisticaMedica team

With over 100 cumulative years of experience in their chosen fields, and almost as many in the clinical research environment, the team at StatisticaMedica has the expertise to provide

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Contact Us

Our mission is to provide first-class biostatistical support, expertise, analysis and consultancy in partnership with our clients. To take the first step towards this first-class support and collaboration, get in touch [link] to start a discussion around your biostatistics requirements