Delivering Global Study


The Challenge

Aptus Clinical were asked by AstraZeneca (AZ) to provide a clinical operations team to deliver their global Phase IIb BEECH study in 11 countries

The Solution
Aptus Clinical efficiently supplied five highly experienced and skilled clinical operations professionals to undertake this work
The Outcome

Working with AZ affiliates and service partners the Aptus Clinical team has over the past 3.5 years successfully supported the BEECH study to set up 41 study sites in 11 countries, enrol 150 breast cancer patients, conduct 2 interim analyses, a PFS analysis and produce a Clinical Study Report

The Feedback

AZ was delighted with the calibre of the team Aptus Clinical provided and the continuity of the same team supporting this study for the past 3.5 years. Aptus Clinical is now supporting the final survival follow-up and study closure and archiving

Aptus Clinical provided three and a half years of highly professional clinical operations support for this complex phase 2 proof-of-concept study, delivering investigator site set-up, study recruitment, follow-up and multiple high-quality database locks. This was a global study, involving sponsor affiliates in 11 countries and utilised off-shore data management with on-shore third party providers for programming, analysis and reporting. The clinical operations team from Aptus Clinical quickly formed collaborative and productive relationships with the distributed global project team and other vendors. Here their experience and ability to proactively identify and resolve bottlenecks within the multiple “moving parts” of the study was a key success factor in the study being delivered to plan”. “The Aptus study team were outstanding in their commitment and ability to drive delivery and I would be happy to recommend them.

Andrew Foxley


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