Drug Safety and Pharmacovigilance Editing and Proofreading Services

Eleven reports of the same rare event have accumulated over fourteen months. They may be a signal. They may be reporting bias after a newspaper article, an artefact of the indication, or eleven coincidences in two hundred thousand patients. Somebody has to write the assessment that decides which, and that document will be read by a regulator who has seen a great many assessments written to reach a conclusion.

We edit what pharmacovigilance functions produce — signal evaluation and assessment reports, signal detection and validation documentation, periodic safety update reports and their benefit-risk sections, risk management plans and safety concern descriptions, aggregate safety review documentation, literature review and screening documentation, benefit-risk assessments and their narratives, responses to regulatory safety questions, safety communications to prescribers and patients, standard operating procedures for case processing, and audit and inspection response documentation. Our editors work on the assessment that has to persuade a sceptical reader.

The signal evaluation is where a pharmacovigilance function demonstrates its judgement, and its failure is presenting the analysis that supports the conclusion. An assessment closing a signal is only credible if it shows the reader what would have kept it open. We work through these so the case series is characterised before it is discounted, with the number of cases, their quality, the proportion with sufficient information for assessment, and how many were confounded, since discounting a series without describing it is the pattern reviewers are trained to notice; so alternative explanations are stated and tested individually rather than gathered as confounding; so the temporal relationship, dechallenge and rechallenge information across the series is summarised, because a series with three positive dechallenges is a different object from one with none; so disproportionality statistics are reported with their limitations rather than either relied on or dismissed, given that both are common and both are visible; so the biological plausibility argument is made in both directions, as an assessment that finds no mechanism should say whether one would be expected; and so the conclusion states what evidence would change it and how the topic will be kept under review. Assessments written this way close signals that stay closed.

Everything you send is treated in confidence, including safety data, assessments and regulatory correspondence. We are editors rather than pharmacovigilance physicians, epidemiologists or regulatory advisers, and we offer no view on signals, causality or benefit-risk. What we can do is make the reasoning visible enough to be believed.