Contract Research Organizations Editing and Proofreading Services

A monitor spends two days at a site and leaves behind a list of findings. The site coordinator, who runs four studies with two days a week of protected time, reads it a fortnight later. Whether anything changes depends almost entirely on whether the findings tell her what to do — and most monitoring reports tell her what was wrong, which she generally knew.

We edit what contract research organisations produce — monitoring visit reports and findings, site communication and follow-up letters, monitoring plans and risk-based strategies, protocol deviation classifications and reporting, corrective and preventive action documentation, site initiation and training material, feasibility and site selection documentation, project proposals, budgets and change orders, sponsor status reporting, quality issue and audit response documentation, and standard operating procedures for clinical operations. Our editors work on the finding a site has to act on.

The monitoring finding is where a CRO either improves a site's conduct or generates paperwork, and its weakness is describing an observation without an action. "Source documentation was incomplete for three subjects" identifies a category and leaves the coordinator to work out which subjects, which fields, and what to do. We work through these so each finding names the specific instances with subject numbers, visits and fields, since a site cannot fix a generality; so the required action is stated with who does it and by when, and the difference between correcting the instances and preventing recurrence is separated, because a site that fixes the three and changes nothing will produce three more; so the finding says why it matters in terms of the study rather than the standard, given that "this affects the primary endpoint data for these subjects" moves a coordinator and "this is a GCP non-compliance" does not; so the classification is stated with what escalation it triggers, so that nothing arrives as a surprise; so anything the site cannot fix alone — a protocol ambiguity, a system limitation, a sponsor decision — is identified as such and routed to whoever owns it, as findings issued against sites for things outside their control destroy the relationship; and so what was found to be in good order is recorded, since a report containing only problems is read as an attack. Reports written this way get acted on before the next visit.

Everything you send is treated in confidence, including study documentation, site information and sponsor material. We are editors rather than clinical research or quality specialists, and we offer no view on findings, compliance or study conduct. What we can do is turn an observation into something a coordinator can do on Tuesday.