RWS speeds up your go-to-trial strategy: How bulk-ordering paper COA translations in advance benefits your studies
2 minutes read
The need for speed
How it works
Most clinical trials, no matter the therapeutic area, include some common, public-domain COAs in their protocols. These are ideal candidates for early paper translation, since no license agreements or developer reviews are required. Licensed scales can also be translated in advance, provided the copyright holder agrees to a license agreement that covers the full period from translation request to FPFV date.
To try to get as many translations ordered in advance as possible, pharmaceutical sponsors can assess their COA translation needs for their upcoming pipeline, be it for a therapeutic area, a specific drug or a series of trials. Sponsors often have several trials coming up in the next year that all use similar COAs, and/or a large country footprint where they’re looking to launch clinical studies in the coming years.
We’ve seen clients order dozens of linguistically validated COAs in 50-70 languages that they know they’ll use for upcoming trials. RWS can offer bulk discounts, maximizing efficiencies in the translation process while still adhering to ISPOR/FDA/EMA guidelines. Having paper COA translations completed well in advance of submission deadlines creates huge time savings, and creates less stress for busy study teams.
The cognitive debriefing process is the part of creating linguistically validated translations that takes the most time and has the highest cost, since patients with the trial’s disease state must be recruited in each country to test the translation’s content. By bundling patient recruitment and interviewer costs and debriefing several COAs at once, RWS is able to save pharmaceutical clients time and money without sacrificing quality.
Benefits
- 12-14 weeks of time saved on future projects (a time savings of ~40-60% depending on the project scope!).
- No rush fees – translations can be completed on Standard timelines since they’re ordered well in advance.
- The ability to complete future eCOA work in ~6 weeks rather than 10 weeks, depending on the eCOA vendor’s processes.
- Maximum reuse of paper COA translations for future studies.
- A sponsor-owned COA translation library that grows over time.
Advance planning for paper = benefits for the electronic administration of COAs too
Contact RWS about this proactive approach