Common Technical Document (CTD)
- CTDs are the application dossiers required for the registration of new medicines in Europe, the USA and Japan, and are the end-product of the clinical development process; they are the ultimate challenge in writing clinical documentation.
- The format and content of CTDs is set out in ICH M4. In particular, the CTD Summary (Module 2, sections 2.5 and 2.7) presents a medical writer with the significant task of summarising all elements of a clinical development programme, sufficient for the reviewer to quickly establish the most critical conclusions of the cumulative dataset.
- Trilogy has extensive experience in preparing hundreds of CTD submissions, from straightforward local variations to complex global submission dossiers for multiple indications.
- Our clients appreciate Trilogy’s proactive involvement in ensuring that all aspects of the clinical development programme are appropriately synthesized in a reviewer-friendly manner.
- Trilogy meets deadlines – a vital factor in successful and timely drug approvals.
- Trilogy can provide eCTD-compliant dossiers in collaboration with a strategic partner.