Investigator Brochures Editing and Proofreading Services

An investigator's brochure has one section that does real work at three in the morning. A patient in a trial has had a serious event, and somebody has to decide within hours whether it is expected — because if it is not, the clock starts on an expedited report to regulators worldwide. That decision is made by reading one list, and the list is often the least carefully drafted part of the document.

We edit what sponsors and medical writers produce — investigator brochures and their annual updates, reference safety information sections, summaries of nonclinical and clinical data for investigators, guidance to the investigator sections, risk and precaution descriptions, dosing and administration summaries, overdose and management information, pharmacology and pharmacokinetics summaries, brochure amendments and their notifications to sites, and the safety documentation that supports expectedness assessment. Our editors work on the list that decides whether a report is expedited.

The reference safety information is where an investigator's brochure earns its keep, and its failure is a list that cannot be applied. Expectedness turns on a specific term at a specific severity, and a brochure describing hepatotoxicity in prose across four paragraphs cannot answer whether grade 3 transaminase elevation in a particular patient is expected. We work through these so the reference safety information is a discrete, clearly identified section rather than something a reader has to assemble from the safety discussion, since assessors and sponsors both need to know exactly which text governs; so each expected event is stated as a term with the severity or grade at which it is expected, because an event expected as mild and occurring as life-threatening is not an expected event; so the frequency is given where known and the source stated, given that pooled trial data and single-study data support different claims; so events described elsewhere in the brochure but deliberately not in the reference safety information are visibly excluded, as this is where confusion arises and where inspectors look; so the version and effective date are unmistakable, since a site assessing expectedness against a superseded brochure is a finding waiting to happen; and so the guidance to the investigator translates the safety information into what to do, rather than restating it. Brochures written this way produce consistent expectedness decisions across forty sites.

Everything you send is treated in confidence, including brochures, safety data and regulatory documents. We are editors rather than clinicians, pharmacovigilance specialists or regulatory advisers, and we offer no view on expectedness, safety or reporting obligations. What we can do is make the governing list unmistakable and applicable.