Clinical study protocols and synopses |
Informed Consent Forms (ICFs) |
Clinical Trial Agreements (CTAs) |
Patient Reported Outcomes (PROs) |
Adverse events-related documentation (SAEs, SARs and SUSARs) |
Clinical questionnaires and case report forms (CRFs) |
Linguistic validation of COAs and cognitive debriefing |
Regulatory approval dossiers |
PILs, SPCs, PSURs and DHPCs |
Labelling and packaging |
User manuals for medical devices |
For patents, I can refer you to a specialised trusted colleague |