Service Description

Trilogy was contracted to prepare 2 phase 4 CSRs. These were both post-approval studies (1 was a post-approval committment for EMA). They were provided with Tables, Figures and Listings, protocol and SAP and a previous example.

What Went Well

Trilogy were able to quickly adapt to changing requirements from the team. Trilogy produced a good quality first draft. Trilogy asked pertinent questions during the preparation phase to elicit the appropriate information from the scientific experts.

What Could Be Improved

Trilogy could have been a little more proactive in communicating progress and timelines. They could also have been a little more involved in the roundtable discussions to ensure all questions were addressed. They could have been more transparent regarding the QC process.

Lessons Learned from the Experience

Trilogy went to great lengths to ensure the report met expectations. They looked into the data and identified issues which required a rerun of the tables, figures and listings - essentially performing a review of the data which should have been done within Data Science. They came up with proposals for text which the team just had to edit.