Complete Clinical Documentation Portfolio

Trilogy offers the scientific expertise and industry experience required to provide the full range of writing and coordination services for the documentation demanded by your clinical programme.

Our services include:

• Cohesive and consistent communication of key messages throughout your product lifecycle
• Application of industry best-practices and standards in document preparation
• Efficient processes to meet tight deadlines
• Continuous and thorough quality control
• Management of your entire documentation cycle

Trilogy specialises in writing all clinical documentation including:

• Pre-submission documents: Clinical Study Protocols (CSPs), Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), Informed Consent Forms (ICFs), Investigational Medicinal Product Dossiers (IMPDs), Investigational New Drug documents (INDs), Paediatric Investigation Plans (PIPs) and Risk Management Plans (RMPs)
• Submission documents: Clinical dossiers in the Common Technical Document (CTD) format for any region
• Post-submission documents: EU explanations and FDA advisory committee meetings
• Safety documents: Annual safety reports (ASRs) and Periodic Safety Update Reports (PSURs)
• Marketing documents: Abstracts, publications for scientific journals and posters for conferences

Irrespective of whether you wish us to act as your outsourced medical writing department or to produce single documents at times when your own internal medical writing team is over-stretched, our portfolio and expertise can be tailored to your needs.

Contact Trilogy with an enquiry for any documentation needs.