Our area of unique expertise is in the support of platelet aggregation and other assays of platelet function in clinical trials. Our support maximises the quality and usefulness of this crucial data in the drug development process.
We offer three main services:
Provision of training, support and data review to assist the performance of platelet function assays at clinical trial sites. Most trial sites are not familiar with these assays, and data quality may suffer in multicentre trials. However, platelet function studies provide vital pharmacodynamic and population response data. As a CRO specialising in this area, our review and support services reduce errors and identify remaining artifactual results. This yields more reliable platelet function data, allowing better decision making as the drug progresses through the clinical development process.
Design, management and interpretation of intensive substudies of platelet function. Such studies may address particular areas of concern, or provide evidence to differentiate a compound from competitors. Aspects that may be studied include pharmacokinetics; pharmacodynamics and signalling; pharmacogenomics and other sources of variability. With our involvement these studies will address crucial uncertainties in areas such as safety, mechanism of action, metabolism or population variation.
Expert consultancy and advice on all aspects of platelet pharmacology, clinical trial design, data analysis and drug development.