Clinical Biostatistics Consulting
Years of clinical biostatistics in oncology and cardiology, now dedicated to closing the evidence gap in women's health: study design, data analysis and digital health validation, project by project.
Why VIMASTAT exists
For decades, clinical research was designed, tested and dosed primarily around men's bodies. Conditions that affect women exclusively or disproportionately, from endometriosis to pregnancy complications, and from autoimmune disease to how a heart attack actually presents in a woman, were often left with thinner evidence, smaller studies and looser statistical rigour, across Europe and beyond. That gap does not close on its own; closing it takes the same discipline used in the highest-stakes areas of medicine, applied deliberately to women's health.
The EU's Clinical Trials Regulation requires studies to represent the population that will use the treatment. Even so, one analysis found women made up just 38% of participants in European cardiovascular trials between 2010–2017, despite cardiovascular disease being their leading cause of death.
Conditions such as endometriosis, PCOS, menopause-related disease and pregnancy complications remain among the least funded, least statistically powered areas of clinical research in Europe, despite affecting millions of women.
Good intentions don't generate valid evidence. Only careful study design, adequate statistical power and sound analysis can tell whether a treatment truly works for women, not just whether it worked in a trial built around someone else.
The same statistical discipline built over years in oncology and cardiology, brought deliberately to women's health research, so evidence in this field is never treated as a lower priority.
What we offer
End-to-end statistical support for clinical research: from the first protocol draft to the final publication, channelling years of experience in oncology and cardiology into women's health.
Statistical planning of clinical trials and observational studies in women's health. Sample size calculation and selection of the most appropriate design for each research question.
Data analysis using advanced methods: mixed models, survival analysis and longitudinal data, choosing a frequentist or Bayesian approach depending on what each research question actually needs.
Consolidated experience across oncology (including breast, ovarian and cervical cancer), as well as cardiology, ophthalmology, respiratory and urology, each with its own endpoints, regulatory expectations and statistical challenges.
Statistical design and analysis for Clinical Evaluation Reports (CER) and Post-Market Clinical Follow-up (PMCF) studies, applying the same clinical-trial-grade rigour and regulatory reporting experience (SAPs, CSRs) to the evidence medical device and digital health companies need under the EU MDR.
Real-world evidence (RWE) analysis and registry-based studies, from disease surveillance and cancer registries to multi-country cardiovascular RWE cohorts, generating robust evidence to support clinical, regulatory or product decisions.
Writing of statistical sections for scientific papers and final study reports, in clear language ready for high-impact journals.
How we work
We listen to the project's scientific or business objective to define its scope, timeline and deliverables, always with a clear focus on results.
We propose the most appropriate design for each study (including complex designs in oncology and cardiology), calculate sample size, and define primary and secondary hypotheses.
Analyses are run in R, the reference language for modern statistical computing, and every result is validated with methodological rigour and efficient turnaround.
Results are presented clearly, with visualisations and reports tailored to their intended clinical, scientific or regulatory use.
Resources
Clinical work is confidential project by project, so instead of client case studies, here's how VIMASTAT actually thinks: in articles and two small tools that work.
Why the sample size calculation is the one decision that determines whether a study can answer its own question.
Read the article → GuideA short guide to the reporting checklists journals expect, and where a biostatistician fits in, earlier than most people think.
Read the article → ResearchWhat the data shows about sex representation in EU cardiovascular research, and why it's a design problem as much as a recruitment one.
Read the article → GuideWhy Post-Market Clinical Follow-up under the EU MDR is a continuous statistical obligation, not paperwork to file once and forget.
Read the article →An interactive calculator for study planning: two proportions, two means, or precision for a single proportion, built in R Shiny, the same stack behind the statistical work itself.
Try the calculator ↗A demo femtech calculator: from a last period date and average cycle length, it estimates upcoming periods and fertile windows, the kind of logic VIMASTAT helps validate with real clinical evidence before it ships.
Try the estimator ↗About VIMASTAT
VIMASTAT brings clinical-trial-grade statistical rigour to women's health. Led by Marta Vilaró, PhD in Statistics and Operational Research from the Universitat Politècnica de Catalunya (BarcelonaTech), the practice draws on more than 13 years of clinical biostatistics experience across oncology, cardiology, ophthalmology, respiratory and urology, where rigorous data analysis is often the difference between the right clinical decision and the wrong one. We bring that same discipline to women's health, a field that still needs more robust evidence and stronger statistical design. LinkedIn ↗
VIMASTAT works on both stand-alone projects and ongoing retainer collaborations: study design, data analysis, digital product validation and robust scientific evidence generation for research teams, hospitals and digital health companies.
The mission is to be the statistical partner every project needs, exactly when it needs it: with a clear focus on results, methodological rigour and efficiency in every delivery.
“Be my stat.” Not just wordplay: it's the promise behind VIMASTAT, a statistical partner close enough to trust with the numbers that matter to your project.
Every project is planned around a clear, measurable objective, and stays focused on it.
Strict application of good statistical practice and international standards, especially in high-complexity areas.
Well-scoped work with clear timelines, whether a single project or an ongoing retainer, without unnecessary structures.
Secure handling of sensitive data with the highest protection standards.
FAQ
A biostatistician turns the research question into a design that can answer it: the right endpoints, the right sample size and a statistical analysis plan agreed before data collection. Once the data arrive, they run and validate the analysis and report the results so they stand up to peer review and regulators. In women's health this also means handling cycle-related variability, hormonal factors and under-represented groups on purpose, not as an afterthought.
As early as possible, ideally before data collection. Endpoints, sample size and the analysis plan are far cheaper to fix on paper than after recruitment, and a poorly sized study cannot be rescued by a clever analysis. More in our guide to sample size. Help is also valuable later, for example when a reviewer questions the statistics in a manuscript.
Yes. VIMASTAT supports the statistical validation of digital health products, such as cycle and fertility estimators, from study design to the evidence behind clinical claims. For products under the EU MDR, we also help plan the statistical side of clinical evaluation and post-market clinical follow-up (PMCF).
Yes. VIMASTAT is based in Catalonia and works remotely with research teams, hospitals and companies across Europe and North America. Projects are run in English, Catalan or Spanish.
Both. Some teams need a well-scoped, stand-alone project, such as a protocol, a sample size calculation or a full analysis; others prefer an ongoing retainer for continuous statistical support across studies. In either case, scope, timeline and deliverables are agreed up front.
Get in touch
Tell us about your project. We offer a free initial consultation to assess how VIMASTAT can help you.