Clinical trials · Real-world evidence · Epidemiology
Dry-lab science for pharma, biotech and research: we design and analyse clinical trials and Danish register studies across the product lifecycle.
Capabilities
Three areas of work. The data source changes between them; the standard for designing a study does not.
The statistician's half of a trial: design, analysis plan, analysis and reporting.
Trial work →Run by us, inside the approved Danish data environment.
How register access works →Survival, competing risks, causal inference and prediction, underneath both.
Selected work →The size and shape of the patient population.
What actually happens after diagnosis.
Trial-level design discipline on real-world data. Explore →
A comparator for a single-arm study, drawn from patients who would have qualified.
After launch, in the patients who were never enrolled; to GVP Module VIII where it is a regulatory commitment.
Whether the question can be answered at all, before anyone commits to a full study.
Track record
Our client work includes randomised trials published in NEJM Evidence, the International Wound Journal and Wound Repair and Regeneration, as well as register and health-economic studies. The team's own record spans human genetics, register epidemiology and clinical trials.
Why Frameshift
No sample size fixes a cohort defined wrong, a time zero that leaks information from the future, or an endpoint chosen after someone has seen the curves.
The analysis plan is signed off before outcome data are examined.
Primary results are checked by a second team member.
Whoever designs the study runs the analysis and writes the methods.
Tables, figures and methods text, ready for submission.
Get in touch
Tell us what you are trying to establish. We usually reply the same or next working day.
> plan(study) #> 1 15–20 min scoping call #> 2 Feasibility read, in writing #> 3 Proposal > reply_time(study) #> [1] "same or next working day" > contact() #> [1] "info@frameshift.dk" > scope()
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