Clinical Study Reports Editing and Proofreading Services

Somewhere in appendix 16.2.7 of a two-thousand-page report there is a paragraph about a fifty-eight-year-old man who was admitted to hospital on day 41. A reviewer will read that paragraph closely, and possibly nothing else on that page. It has to tell them what happened, in what order, and whether the drug could plausibly have caused it — and it was written by somebody working through the eleventh narrative that afternoon.

We edit what sponsors and medical writers produce — clinical study reports and their synopses, individual patient narratives for deaths, serious adverse events and discontinuations, safety and efficacy result sections, statistical results converted into prose, protocol deviation summaries, integrated summaries of safety and efficacy, briefing documents and regulatory responses, publication manuscripts derived from study reports, and lay summaries of trial results. Our editors work on the narratives a reviewer reads word by word.

The individual patient narrative is where a clinical study report is either useful to an assessor or merely compliant, and it fails by listing events rather than sequencing them. A narrative that reports what happened without study days, without what was already true of the patient, and without the temporal relationship to dosing cannot support any causality judgement at all. We work through these so the narrative opens with who the patient was in the terms that matter — age, sex, the condition under study, the relevant medical history and concomitant medications, because a cardiac event in someone with three prior stents reads differently and the reader should not have to look it up; so events are given by study day and by time relative to the most recent dose, since a reaction four hours after infusion and one eleven days after are different findings; so the sequence is strictly chronological, with what was done, by whom and with what result, rather than grouped by category; so treatment interruption, dechallenge and any rechallenge are stated explicitly with what happened after each, as this is the strongest causality evidence available and it is often buried; so the investigator's causality assessment is reported as the investigator's, distinguished from the sponsor's, given that they sometimes differ and the difference is informative; and so the outcome and its date are stated rather than left as ongoing. Narratives written this way answer the reviewer's question in the paragraph rather than in a request for information.

Everything you send is treated in confidence, including study data, narratives and regulatory documents. We are editors rather than clinicians, pharmacovigilance specialists or statisticians, and we offer no view on causality, safety or study conclusions. What we can do is make each narrative tell the sequence.