How structured iteration and documented register decisions produced a French PLSS that cleared sponsor review without linguistic queries.
The client
A pharmaceutical sponsor running a Phase 2 randomized, double-blind, placebo-controlled trial evaluating an investigational monoclonal antibody in a rare chronic pulmonary condition. The plain language results summary was required for submission to the CTIS portal and for publication on both euclinicaltrials.eu and clinicaltrials.gov.
The challenge
Writing a French plain language results summary requires holding two standards in tension at once. Under EU CTR 536/2014, the content must be understandable to patients with no scientific background while remaining precise enough to withstand ANSM scrutiny, and it cannot read as promotional, however strong the trial data appears.
The endpoint data in this trial included complex information such as forced vital capacity measurements, treatment response rates, and adverse event incidence. Simplifying these concepts without compromising integrity required careful linguistic and regulatory judgment that would not distort the overall picture. Getting the French right was paramount as the text was simplified without losing what regulatory teams needed to see.
The document also referenced two registries at once: the EU CT number on euclinicaltrials.eu and the US NCT number on clinicaltrials.gov, each with its own navigational language and identifiers to be adapted correctly in French.
The solution
Rather than producing a single draft for comment, we approached the work as a collaborative, iterative process from the start. Each register decision was documented throughout the process – not as a formality, but so the sponsor could have full visibility into the reasoning behind each language choice.
The GLSP guidance (EC October 2021) served as our drafting reference throughout, not just as a compliance checkbox, to validate our plain language choices for key endpoint terms against the guidance’s own vocabulary criteria. This gave the documented rationale an external standard to anchor to rather than relying solely on our own or the sponsor’s judgment.
In parallel, registry-specific navigational language, identifiers, and reference links were verified and adapted for both platforms as part of the same delivery.
The results
- Final French PLSS delivered with full documentation of register decisions, after one single review round
- No linguistic queries were raised by the sponsor
- Endpoint result language – including forced vital capacity, treatment response rates, adverse event incidence – rendered through multiple drafting passes to achieve French that reads as originally composed rather than translated.
- Registry-specific identifiers, navigational language, and reference links verified and adapted for both euclinicaltrials.eu and clinicaltrials.gov within the same delivery.
