Biostatistics & Clinical Trial Methodology · Copenhagen
Frameshift is a biostatistics consultancy supporting biotech sponsors, CROs, and academic research groups. We deliver statistical analysis plans, clinical study reports, and publication-ready outputs, from protocol to manuscript.
Who we are
We are methodologists. Study design, analysis plans, and interpretation follow from the statistics, not the other way around.
Statistical design and registry epidemiology. Leads methodological work on clinical trials and observational studies, with a focus on translating complex analyses into decisions that hold up under scrutiny.
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Translational science and clinical biomedical reasoning. Bridges academic rigour and industry practicality, from study conception through interpretation and reporting.
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Machine learning and computational analysis applied to clinical and health research. Brings model development and validation expertise to projects where standard methods are insufficient.
LinkedIn →We work with teams that have data and broad objectives, and want to shape clear analytical paths. That often means clarifying what can credibly be supported and which analyses are worth pursuing.
Clear, decision-ready SAPs, trial analyses, and reporting that defines estimands, endpoints, population, and strategy from the outset. Costs tend to surface from ambiguity.
Design and execution of observational studies using health registers and other real-world data. Credible results rely on attention to bias, timing, and comparability.
Frameshift Insights
Methodological essays on epidemiology, biostatistics, and study design.
A new Danish nationwide register study followed 1.5 million children and found no association between prenatal acetaminophen exposure and autism, even in a sibling-matched analysis. A look at what the study shows, what the registers made possible, and why the evidence has only converged further.
The Guardian reported that CRC is now the #1 cancer killer in Americans under 50. We pooled 44 years of NORDCAN data across five countries. The trend is real, but the ranking is not: CRC is #3 in the Nordics for both sexes, and the rise is hitting young men hardest.
A 2013 Danish register study found that skin cancer patients had half the all-cause mortality of the general population, an effect that survives even a lottery prize with no biological mechanism whatsoever. Here is why.
Research
Peer-reviewed papers in clinical trials, epidemiology, and biostatistical methods.
Randomised trial across 255 patients testing fish skin grafts against standard care for deep diabetic foot ulcers. Fish skin achieved wound closure in 44% versus 26% at 16 weeks.
View Article →Danish registry study of 30,000 patients showing infection burden is elevated up to 15 years before diagnosis of B-cell malignancies, with implications for early immune dysfunction and prognosis.
View Article →Nationwide Danish cohort and genetic risk score study finding shared aetiological pathways between migraine and pre-eclampsia, with implications for cardiovascular risk stratification.
View Article →What we deliver
Deliverables for biotech teams and research groups, across the full analytical lifecycle.
Pre-specified SAPs for clinical trials and observational studies, including endpoint definitions, multiplicity strategies, and regulatory-ready documentation.
Primary, secondary, and exploratory analyses for Phase I–IV trials. Clinical study reports and tables, listings, figures (TLFs).
Study design, cohort definition, and analysis using Danish national registers and Nordic administrative data at population scale.
Comparative effectiveness, treatment utilisation, and health outcomes studies using claims, registry, or EHR data.
Publication-quality figures, statistical methods sections, results interpretation, and manuscript support for peer-reviewed journals.
Ongoing senior biostatistical support integrated into your team, from early-phase scoping through final deliverables.
Get in touch
We work best with teams that have a defined research question and need statistical methodology, analysis, or reporting support. Tell us about your project and we will typically respond within one business day.
