Do you offer QC, peer review and formatting services only? +
Yes. Irrespective of whether we authored the document, we can support it through expert peer review, quality control against dedicated QC checklists, and professional formatting. These services can be commissioned on their own, without any authoring scope attached.
How do you ensure clinical trial report consistency with the SAP and TFLs? +
The report is authored against the SAP and the TFL shells the programmers code from, with biostatistical review running in parallel rather than as a hand-off at the end. Our medical writers work in close collaboration with the biostatisticians and programmers who own those outputs, so the narrative and the numbers stay in step as both develop.
Do you write protocols from scratch or only edit? +
Both — though we strongly prefer to be involved from the synopsis stage. Protocols co-authored with biostatistics from day one have meaningfully fewer amendments and cleaner deviations than protocols inherited late. Authoring follows ICH E6, ICH E8 and the ICH M11 protocol template where the sponsor works to it.
Can you write ISS / ISE narratives? +
Yes — both the integrated safety summary and integrated efficacy summary, with full traceability across pooled trials and CDISC-compliant supporting datasets. Routine ISS/ISE work is part of our submission portfolio.
Do you support EU CTR lay summaries? +
Yes. EU CTR has changed the lay-summary expectation significantly. We write to the 2024 best-practice guidance with participant-friendly language reviewed for accessibility.
Do you handle eCTD submissions? +
We prepare and quality-control the documents that go into an eCTD submission — CTD Module 2 content, integrated summaries and supporting reports — formatted and checked so they drop straight into your dossier. We do not run the technical publishing process itself: the eCTD compilation, validation and gateway upload stay with your publishing vendor or in-house team, and we work alongside them.
