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Medical Writing, Methodology & Data Valorization

Turn your clinical data into clear, compliant and impactful evidence.

Our cross-functional team of PhDs and MDs brings strong expertise in epidemiology, biostatistics and medical writing. This integrated model ensures scientific rigor, consistency and efficiency across the full lifecycle of your clinical projects—from early design to publication and market access.
All our writers are members of EMWA, and our Department Director is also a member of AMWA.
You can rely on us for the full cycle—from study conception to data analysis and writing—or we can step in for a single activity. Our structure offers agility, consistency and tailor-made support for every project.
Discover how we support your projects: click on each section below to learn more.

Methodology & Study Design

We design fit-for-purpose studies aligned with your clinical, regulatory and strategic objectives.

Our support includes:
  • Study design tailored to your development plan – ensuring studies fit your clinical and strategic objectives
  • Definition of endpoints and methodology – selecting relevant outcomes and robust study approaches
  • Sample size estimation – calculating numbers that meet scientific and operational goals
  • Anticipation of methodological risks – identifying and mitigating potential challenges early
  • Guidance from early phases to post-launch evidence – supporting your strategy from early access programs through real-world application

We produce and review all scientific and regulatory documents with clarity, precision and full compliance with GCP, ICH, ISO and MDR/IVDR.

Our team covers:
  • Protocols & Clinical Investigation Plans – ensuring all study documentation is clear, accurate, and regulatory-compliant
  • Study Reports (CSR/CIR) – providing structured, comprehensive, and audit-ready reports
  • Investigator Brochures – summarizing clinical data to support investigator understanding and regulatory requirements
  • Regulatory submission documentation – preparing dossiers that meet global submission standards
  • Literature reviews (systematic, meta-analysis, narrative, SOTA) – providing evidence-based analyses to inform study design and strategy
  • Informed consent materials – ensuring patient-friendly, compliant, and clear information
  • Translation & multilingual adaptation – delivering high-quality versions for global studies while maintaining accuracy

Our biostatisticians manage the entire analytical workflow, from SAP development to SAS programming and production of TFLs, ensuring traceability and robustness.

We help you transform results into value:
  • Manuscripts, abstracts, posters – communicating study results effectively for publication and presentation
  • Expert committee and conference materials – supporting clear and impactful presentations to scientific and regulatory audiences
  • Market access and reimbursement dossiers – preparing evidence packages to facilitate regulatory approval and reimbursement
  • Strategic scientific communication – translating complex data into actionable insights for stakeholders

You can rely on us for the full cycle — from study conception to data analysis and writing — or we can step in for a single activity.
Our structure offers agility, consistency and tailor-made support for every project.

Ready to take your clinical projects to the next level?
Contact our team today to discuss how we can support your study design, data analysis, and medical writing needs. Get in touch with us.

Key deliverables

Study Protocols / Clinical Investigation Plans / PUT-RD
Investigator’s Brochures (IB)
CSR, CIR & periodic reports
Patient-facing documents (ICFs, information sheets)
Statistical Analysis Plans (SAP)
Tables, Figures & Listings (TFLs)
Manuscripts, abstracts, posters, presentations
Literature reviews
Regulatory submission dossiers
Market access / reimbursement files
Methodological consulting & risk analysis reports

Activities

Medical Writing
SAS Programming
Methodological / Scientific Monitoring

Standards

ICH E9
ICH E3
ISO 14155