Paspartu offers Pharma Translation Services (clinical, regulatory), catering for the complex translation requirements of key life sciences organizations: pharmaceutical producers, academia, CROs (Contract Research Organizations), biotechnology companies in over 40 languages.
With +16 years of experience in the life sciences & pharma industry, our native medical translators and Subject Matter Experts can help translate documentation in all stages of the product life cycle.
We cover translations for:
1-clinical research and pharmacovigilance
1. Translations for clinical research/ trials
Clinical trials involve patients and healthy volunteers around the world. Consequntly, they pose safety, ethical and policy considerations, requiring tight regulation along with accurate documentation.
At Paspartu we translate both Patient-facing documentation, as well as Physician-facing documentation.
Patient-facing documents- involves translation where language is clear and easily-understood by the lay patients.
Physician-facing documents- involves translation where more specialised language appropriate to the physician or researcher is needed.
Translation of clinical documents
- Lay Summaries
- Protocol synopses
- Clinical study protocols
- Informed Consent Forms (ICFs)
- Patient/Doctor information sheets
- Investigator’s Brochures (IBs)
- Investigators’ CVs
- Case Report Forms
- Adverse Event Report (AER) forms
- Insert and label text/labelling
- Electronic Patient Reported Outcomes (ePROs)
- Quality of Life (QoL) instruments
- Patient diaries and questionnaires
Paspartu applies strict quality control and confidentiality standards as defined by our ISO 17100 certification in order to ensure accurate and precise translation, vital for patient safety.
2. Translations for Regulatory Affairs
Paspartu is a certified translation vendor of the European Medicines Agency, of the European Chemicals Agency, and a trusted partner of private pharma producers and CROs around the globe.
We translate European Medicines Agency (EMA) Marketing Authorisation Applications (MAAs) using QRD (Quality Review of Documents) templates for human or veterinary medicinal products.
Our medical translation team has vast expertise in the translation of Product Information of vital drugs, as required by the EMA for MAAs and Variations procedures, as well as documents for Mutual Recognition Procedure and the Decentralised Procedure, required for new Member States.
We typically translate and harmonize versions of:
- product information for the Common Technical Document (CTD)
Check this useful article on LinkedIn, about Pharma Translation Services- clinical, regulatory https://www.linkedin.com/feed/update/urn:li:activity:7026843715037970433
Here you can read more about our expertise in medical translation https://www.paspartutranslations.com/blog/a-history-of-medical-translation/
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