• Clinical Trials

  • Case report forms (CRFs)

  • Clinical study agreements

  • Clinical trial protocols

  • Informed consent forms (ICFs)

  • Investigator’s brochures (IBs)

  • Lay summaries

  • Patient Information Sheets (PIS)

  • Patient recruitment materials

  • Pharmacological studies

  • Scientific publications (papers, posters, abstracts)

  • Standard operating procedures (SOPs)

  • Study reports​

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• Regulatory Documentation​

  • Annex I – Summary of Product Characteristics

  • Annex II

  • Annex III – Labelling and Package Leaflet

  • Annex A

  • Annex IV

  • Annex 127a

• Medical Devices​

  • Instructions for use (IFUs)

  • Accompanying information

  • Labeling particulars

  • Summary of safety and performance

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• Education & Promotional Materials​

  • Marketing and advertising pieces

  • Patient education resources

  • Plain language materials

  • Press releases

  • Product brochures and catalogs

  • Training materials​​

  • Websites and apps

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• ​Consent forms and patient information

• Drug information like package inserts or user guides for medical devices

• Patient information materials

• Plain language summaries

• Study summaries

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• Congress and meeting reports

• Conference abstracts and posters

• Manuscripts and book chapters

• News and press releases

• Online content like websites and blogs

• Slide decks and training materials

• Systematic literature reviews​

• Clinical Outcome Assessment (COA) measures

  • Clinician-reported outcomes (ClinRO)

  • Patient-Reported Outcomes (PRO)

  • Performance Outcomes (PerfO)

  • Observer-Reported Outcomes (ObsRO)​

• Patient diaries

• Quality of Life (QoL) assessment tools

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