Medical Writing

At DICE, we provide end to end medical writing support across the clinical development lifecycle, from early protocols to clinical study reports, manuscripts, and regulatory submission documents. Our writing is scientifically rigorous, consistent across documents, and aligned with EMA and FDA expectations.

Clinical protocols and amendments

Development of clear, robust and regulator ready protocols, including study rationale, objectives, endpoints and analysis principles, as well as protocol amendments reflecting evolving study needs.

Clinical Study Reports

Preparation of high quality CSRs in line with ICH E3 guidelines, including interim and final reports, with a strong focus on data interpretation, consistency, and clarity.

Regulatory documents

Authoring of key clinical documents to support regulatory submissions, including clinical overviews, clinical summaries, Investigator’s Brochures (IBs), briefing books, and responses to regulatory questions.

Manuscripts and publications

Development of scientific manuscripts, abstracts, and posters for peer reviewed journals and conferences, ensuring accurate representation of study results and alignment with publication standards.

Integrated summaries (ISS/ISE support)

Medical writing support for integrated safety and efficacy documents, ensuring consistency across studies and alignment with statistical outputs.

Common challenges we help prevent

• Inconsistencies between protocol, SAP, CSR, and regulatory documents
• Ambiguity in study objectives, endpoints, or interpretation of results
• Delays caused by late document revisions or unclear authoring responsibilities
• Misalignment with regulatory guidance or reviewer expectations
• Documents that are technically correct but difficult to read or interpret

The result

You receive clear, consistent, and submission ready documents that accurately reflect your data, support regulatory review, and facilitate confident decision making.

How we work

We work as an integrated extension of your team, collaborating closely with clinical, biostatistics, data management, and regulatory stakeholders to ensure seamless alignment across all study deliverables.
By uniting medical writing, biostatistics, and data management within a single CRO framework, we ensure consistent interpretation of data, clear scientific messaging, and end‑to‑end traceability across all study documents, from protocol through final reports and submissions.