Clinical Trials

Translation companies and Contract Research Organisations (CROs) manage sensitive, specialised documentation, and follow strict workflows and delivery times.

Project kick-off

When a client sends me a project, I check the source files in terms of content, technical aspects and deadline viability. My client will usually hear back from me within 30 minutes. In the case of a first project, I sign a non-disclosure agreement.

Translation process

The translation workflow often starts with a scanned PDF, which I convert to an editable format. To control the document version and any updates, I use footer inserts and tracked changes in Word. I’m an advanced certified user of SDL Trados Studio and keep glossaries and run customised QA checks to ensure consistency. At the end of the translation process, I issue a digitally-signed certificate of translation, if required.

Standard documents

  • Protocols, IBs, ICFs, and their back translations
  • EudraCT forms and AEMPS annexes
  • EC letters, clinical trial agreements and lab certificates
  • SmPCs, PLs and labelling

Regulatory compliance

I keep abreast of legislative changes and give workshops on terminology and regulatory affairs.
The articles I publish in this field serve as a reference for the close on a thousand translators who subscribe to my blog.

Fees

I usually charge a per word rate. However, clinical trial templates and annexes are repetitive, so it’s sometimes better for both parties to apply an hourly rate. My hourly charge is €75.00.

Samples

For confidentiality reasons, I’m unable to share samples of my translations of clinical trial documents. However, my samples’ page includes other types of medical texts, and I’m also happy to translate a free short sample of up to 200 words.

Testimonials

Like the reviews on the back of a novel, testimonials on translators’ websites are always glowing. But in this case it’s true: my clients are satisfied or actually delighted with my work 99.9% of the time. Read some of their comments in my testimonials’ section.
Spoiler: All testimonials are highly flattering.



A clinical trial


is a delicate matter


involving experimentation


in humans