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 Clinical 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
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
I offer linguistic validation services
for Patient-Reported Outcomes and Quality of Life measures based on the steps recommended by ISPOR:
Back translation review
Review and finalization
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.
Think I might be a good partner for your next project?