Trilogy can take the responsibility for your entire clinical documentation. We have extensive experience in preparing all types of clinical documents and CTD submissions. We have written hundreds of CSRs for all phases of clinical development and most indications. We have also planned and prepared dozens of CTDs, from straightforward local variations to complex global submission dossiers. In short: we have the capacity and experience to meet the needs of your development programme – however complex. We aim to anticipate your documentation needs and to ensure the best possible linkage between the various documents that are written in the different stages of the development cycle, thereby ensuring efficient and timely preparation.
As part of a “functional outsourcing” clinical development team, and based on your annual programme of work, Trilogy can manage your entire documentation needs – acting as an invaluable “glue”, to bring diverse organisations and locations together via the documentation. Working as a “catalyst”, we constructively challenge the clinical team throughout the development and documentation process – to keep messages clear, while we simultaneously project manage – to keep documents on time.
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