Legal

How we engage

Frameshift takes on work directly for pharmaceutical, biotech and research organisations, and as a subcontractor to CROs and consultancies where Danish register access or Nordic methodological expertise is the missing part of a larger programme. In a subcontracted engagement the sponsor relationship, and any regulatory commitment attached to the study, stay with the prime contractor.

Registry data access

Frameshift ApS holds its own authorisation to work with Danish register data. Individual studies additionally require project-level approval, which is obtained per study and which we account for in the project timeline at scoping. Documentation of our authorisation is available to prospective clients on request.

Register data are analysed within the approved environment for the project. The underlying data remain the property of the relevant Danish authorities. No personal data are transferred to clients, and clients do not send us personal data for registry work. What is delivered is the analysis, its outputs and its documentation, including the cohort, exposure, covariate and outcome definitions the results rest on.

Data protection

Registry work runs under our own authorisation, and no personal data are transferred to or from clients. Controller and processor roles follow from who determines the purposes and means of the processing, not from whether personal data physically move. We confirm and record the roles for each engagement before work begins. Where an engagement involves a client providing personal data, for example clinical-trial data, a data processing agreement is put in place before any processing begins. A standard agreement is available on request.

How studies are run

The following apply to every study we deliver.

The statistical analysis plan is signed off before outcome data are examined.
Primary results are independently checked by a second member of the team.
Any deviation from the prespecified plan is logged and reported alongside the findings.

Where a study rests on assumptions that cannot be verified in the available data, those assumptions are stated in the reporting rather than left implicit.

Disclaimer

The content on this website, including blog posts and analyses, is provided for informational and educational purposes only. We check what we publish, but nothing on this site constitutes medical advice, regulatory guidance, or a professional recommendation. Any data analyses, simulations, or interpretations presented are illustrative and should not be used as a basis for clinical or business decisions without independent verification.

Intellectual property

All original content on this website, including text, figures, code, and design, is the property of Frameshift ApS unless otherwise stated. Content may be shared or referenced with appropriate attribution. Where third-party data sources are used (e.g. NORDCAN, national registries), the underlying data remain the property of their respective owners.

Liability

Frameshift ApS accepts no liability for any loss or damage arising from the use of information on this website. External links are provided for convenience and do not imply endorsement of the linked content.