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.