Geir Bjørklund

Medical Writer & Scientific Advisor

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Case Studies

Projects are anonymised and outcome-oriented. Each example sets the question, the method, the deliverables, and the result so decision-makers can judge fit. Client identities and data are protected under mutual non-disclosure; materials are anonymised before any external use.

A late-stage nutrition company sought clarity on whether specific product claims could be supported across multiple jurisdictions. The engagement began with a targeted literature sweep and a short protocol defining inclusion criteria, endpoints, and bias assessment. Human data were mapped to claims pathways and graded by evidence hierarchy. The deliverables were a decision brief for leadership, a technical appendix with search strings and selection flow, and calibrated claims language for regulatory and marketing review. The leadership team adopted the recommended claims and sequencing on an expedited timeline; a follow-on manuscript was submitted and accepted with minor revisions.

A biotechnology team preparing a Phase II programme needed protocol language, statistical analysis plan wording, and a literature section consistent with internal governance and health authority expectations. A single authoring stream harmonised terminology across modules, linked narrative to tables and figures, and documented assumptions for reviewers. The first draft landed on the agreed date with tracked changes and a comment log. One focused revision round closed open questions from clinical, biostatistics, and regulatory. The package met the internal deadline for governance and was filed on schedule.

An environmental health unit faced external scrutiny about an ingredient’s margin of safety. The assignment defined exposure scenarios, collated hazard data from authoritative sources, and calculated margins with explicit assumptions and uncertainty statements. Outputs included concise technical memoranda and an executive summary designed for legal and corporate affairs. The materials addressed key questions in a single review cycle and were used in external communications without further edits.

An investor conducting diligence on a platform technology requested a rapid assessment of efficacy and safety signals, study quality, and translational plausibility. The review used predefined search strings, quality scoring, and effect-direction plots to show where claims were robust and where they were fragile. The deliverable was a decision note with options, risks, and trigger points for confirmatory work. The investment committee received a clear rationale for proceeding with contingencies, and follow-up workstreams were scoped on an expedited timeline.

Across assignments, the constant elements are transparent method, auditable sources, careful wording, and disciplined turnaround. Draft one arrives with tracked changes and a comment log; a focused revision round is included; source files and reference libraries are transferred at completion. Materials integrate with document control and information-security requirements and align with good-practice standards used by clinical, regulatory, medical affairs, and R&D teams.

To discuss a project, share the objective, the audience, the due date, the applicable standards, and any confidentiality requirements. A written proposal will define the method, deliverables, schedule, and price as fixed or capped, with milestones that match internal governance.

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