Medical & scientific writing.
Study reports, manuscripts, abstracts, lay summaries and dossiers, written to the standard reviewers, editors and readers expect. Results are not evidence until someone can act on them.
The work, made concrete.
Not a service brochure, the actual scope, the actual deliverables, and how it plugs into ECS®.
- Clinical study reports (CSR)ICH E3-aligned CSRs that hold up in review, with the narrative built straight from the data.
- Manuscripts & abstractsPeer-review-grade manuscripts, congress abstracts, posters and presentations, publication-planned from the start.
- Lay summaries & plain-languageEU CTR-compliant lay summaries and participant-facing communication in the languages that matter.
- Regulatory dossier sectionsCTD Modules 2.5 / 2.7, MDR clinical evaluation reports, EFSA/FDA claim dossiers, written by writers who read the guidance.
Every deliverable has a name on it.
What you receive.
Every engagement lands with named artefacts you can use.
- CSR (ICH E3 standard)
- Manuscripts, abstracts, posters, congress materials
- Lay summaries (EU CTR-compliant)
- Dossier sections for the regulatory route in scope
The manuscript uses the same numbers as the CSR, which uses the same numbers as the database lock. One ecosystem, one source of truth, no version drift between the report and the paper.
Three moments this service earns its place.
If any of these describe where you are, this is the right entry point.
- Moment 01
You have data and need to turn it into a CSR + publication package.
- Moment 02
A prior manuscript was declined and needs a strategic rewrite.
- Moment 03
You're preparing a submission and the narrative needs to be watertight.
Often engaged together.
Biostatistics & data management
Sample size, SAP, statistical programming and clean, analysis-ready CDISC data.
Learn moreRegulatory strategy, submission and market access
Route to approval and route to reimbursement: feasibility, EMA/FDA and MDR/IVDR pathways, submissions, HEOR and payer dossiers.
Learn moreEvidence strategy & study design
Map the evidence path, position the product scientifically, and design protocols and endpoints across every domain and product class.
Learn moreTalk to the team about this service.
Tell us the study or the question, we'll come back with a scoped answer.