Clinical Trials

as required by the EU Clinical Trial Regulation (CTR) to ensure the safety for participants and increased transparency of trial information among CROs, sponsors and regulatory authorities.

• Adverse events documentation

• Case Report Forms (CRFs)

• Clinical study agreements

• Clinical trial protocols

• Informed consent forms (ICFs)

• Investigator’s brochures (IBs)

• Patient instructions and information

• Patient recruitment materials

• Pharmacological studies

• Plain language summaries *

• Scientific publications (papers, posters, abstracts)

• Standard operating procedures (SOPs)

• Study reports

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* Lay summaries must be published in the language of each country where the trial took place no later than 1 year after trial completion.

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Medical devices

as required by the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

• Instructions for use (IFUs)

• Information supplied (for self-testing or near-patient testing devices)

• Labeling particulars

• Summary of safety and performance (for class III and implantable devices)​​

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Education/Promotional Materials

• Marketing and advertising pieces

• Patient education materials

• Press releases

• Product brochures and catalogs

• Training materials​​

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Regulatory documentation

as required for the European Medicines Agency (EMA)  for any centrally authorized product.

• Annex I – Summary of Product Characteristics

• Annex II

• Annex III – Labelling and Package Leaflet

• Annex A

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When applicable:

• Annex IV

• Annex 127a​

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Linguistic Validation

• Patient diaries

• Patient-Reported Outcomes (PROs) measures

• Quality of Life (QoL) measures

• Clinician-reported outcome (ClinRO) measures

• Observer-reported outcome (ObsRO) measures

According to well-published methodology and industry guidance (ISPOR and ISOQOL):

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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

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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