We both know that your content needs to be translated by someone who offers you specialized knowledge, linguistic and translation skills, and full understanding of the relevant regulations and procedures.

Here are some of the materials I translate for Life Sciences companies and Contract Research Organizations that choose me as their partner:

• Adverse events documentation

• Case report forms (CRFs)

• Clinical trial protocols

• Healthcare informational brochures

• Informed consent forms (ICFs)

• Investigator’s brochures (IBs)

• Instructions for use (IFUs)

• Market research and surveys

• Packaging and labeling

• Patient questionnaires

• Press releases

• Product information: SmPCs, PILs, packaging/labeling materials
  (in compliance with EMA QRD templates)

• Promotional and informational leaflets for medical professionals

• Regulatory approval dossiers

• Standard operating procedures (SOPs)

• Technical manuals and user’s guides

• Training material​

I offer linguistic validation services
for Patient-Reported Outcomes
and Quality of Life measures  according to a well-published methodology and industry guidance:

1. Preparation

2. Forward translation

3. Reconciliation

4. Back translation

5. Back translation review

6. Harmonization

7. Cognitive debriefing

8. Review and finalization

9. Proofreading

10. Final report

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In addition to these steps, I facilitate the clinician review in collaboration with a clinician specialized in the field.

I can also assist you with eCOA integration if you’re interested in migrating the paper version to an electronic format.

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