Clinical Trial Sponsors Editing and Proofreading Services

A coordinator at site 14 is looking at a patient who is nearly eligible. The protocol says stable dose for three months; this patient has been stable for eleven weeks. It says no significant renal impairment; her eGFR is 47. She is keen, she fits the spirit of the study, and recruitment is behind. What the coordinator does next is determined by how the criteria were written, and it will be discovered eighteen months later during database lock.

We edit what trial sponsors and study teams produce — protocols and their eligibility criteria, protocol amendments and their rationales, investigator brochures and site-facing summaries, site training and start-up material, informed consent templates for sites to adapt, monitoring plans and data management plans, statistical analysis plan narratives, protocol deviation and waiver documentation, recruitment material and patient-facing study information, ethics and regulatory submissions, and communications to sites during a study. Our editors work on the criteria sites have to apply at the desk.

Eligibility criteria are where protocol design meets a real coordinator with a real patient, and their failure is being written to describe a population rather than to be applied to an individual. Every criterion requiring interpretation will be interpreted, differently, at forty sites. We work through these so each criterion is a testable statement with its measurement, its threshold and its window — not "adequate renal function" but the specific value, from which test, within how many days of randomisation; so words like significant, clinically relevant, stable and adequate are removed or defined, since these are the ones that generate deviations and waivers; so each criterion states what to do at the boundary, because a value exactly at the threshold is a question somebody will telephone about at every site; so the criteria are ordered as a site would apply them, with the cheap exclusions before the expensive assessments, given that this is a real cost in screening; so any criterion that requires judgement is accompanied by who makes it and whether the medical monitor must be contacted; and so the reason for each criterion is available to sites, as a coordinator who understands why a washout exists applies it more faithfully than one following a rule. Protocols written this way produce fewer deviations, which is the cheapest quality improvement available to a sponsor.

Everything you send is treated in confidence, including protocols, unpublished data and study documentation. We are editors rather than clinicians, statisticians or regulatory advisers, and we offer no view on study design, eligibility or conduct. What we can do is make each criterion produce the same answer at every site.