Clinical trials · Real-world evidence · Epidemiology

Biostatistics and evidence generation, from trials to national registers.

Dry-lab science for pharma, biotech and research: we design and analyse clinical trials and Danish register studies across the product lifecycle.

Capabilities

What we generate.

Three areas of work. The data source changes between them; the standard for designing a study does not.

Clinical trials

The statistician's half of a trial: design, analysis plan, analysis and reporting.

Trial work →

Biostatistics & epidemiology

Survival, competing risks, causal inference and prediction, underneath both.

Selected work →

Six register study types

  1. 01

    Disease Epidemiology & Burden

    The size and shape of the patient population.

  2. 02

    Treatment Patterns & Patient Journeys

    What actually happens after diagnosis.

  3. 04

    External Control Arms

    A comparator for a single-arm study, drawn from patients who would have qualified.

  4. 05

    Post-Authorisation Safety & Effectiveness (PASS)

    After launch, in the patients who were never enrolled; to GVP Module VIII where it is a regulatory commitment.

  5. 06

    Feasibility & Data Strategy

    Whether the question can be answered at all, before anyone commits to a full study.

Track record

Selected work.

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.

See all →
Clinical Epidemiology2025
Registry data resource

The Danish Lymphoid Cancer Research (DALY-CARE) Data Resource: The Basis for Developing Data-Driven Hematology

View Article →
npj Aging2026
National cancer burden

Disentangling shifting demographic and treatment effects on years of life lost to cancer in Denmark

View Article →
+54 more studies →

Why Frameshift

Design before data.

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.

Ólafur B. Davíðsson

Ólafur B. Davíðsson

Co-Founder & Lead Biostatistician
Ragnar P. Kristjánsson

Ragnar P. Kristjánsson

Co-Founder & Managing Director
Mikkel Werling

Mikkel Werling

Computational Methods Lead

Get in touch

Planning a trial
or a register study?

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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