The research objective
A major pharmaceutical company approached Java with the goal of developing a new antiplatelet agent.
As part of Phase II studies, platelet function assessments were needed at sites worldwide to supply vital pharmacodynamic data.
Java installed specialised equipment and trained operators (many of whom had no laboratory experience) in a customised platelet function assay (platelet aggregation) in sites throughout Europe, Russia, India, North and South America, Africa and Australia. In addition, Java developed a programme to ensure the effective analysis of high quality data in the study. This included:
- Ongoing training
- Operator validation
- Data quality review
Java also provided additional support to this study, including assay troubleshooting, data management and consultancy.
Based on our experience in this area, we were able to:
- Successfully deliver vital pharmacodynamic data in a major phase II clinical trial (published in Wiviott et al.)
- Effectively analyse and interpret the platelet function data
- Advise the client on its implications for the future of the drug development programme