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 and urology
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
Clinical Trial Design Services
Innovative and effective approaches to clinical trial design
Biostatistical Advisory and Consultancy Services
High-level advisory and consulting services
Medical Writing Services
Specialist services and expertise in Medical Writing to support your regulatory submission
Data Management Services
Complementary data management services in addition to our core biostatistics
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…
Read moreMDR: 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...
Read moreMeet 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…
Read more
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