Medical affairs consultancy
Our team plans and coordinates all operational activities required for the collection, delivery and assay of Biomarker Samples (Diagnostic and Pharmacodynamic) within your clinical study.
We work closely with scientists to execute exploratory and dosages strategies, serving as a single point of contact on investigational team , logistics and determination/execution teams on all aspects of Bio-sample operations.
We ensure consistency across studies within their clinical biology/biomarkers project(s) by providing oversight for end-to end bio-sample operations.
We develop project specific tools and documents to streamline activities and aligns processes surrounding vendor selection and management in all countries of coverage. We assess continuously the resourcing needs of the projects handed to us.
Our operational support for biomarker analysis includes providing input on Protocol/ICF development and IRB/HA/EC questions in alignment with study protocols as well as a facilitation of central lab set up, including sample collection and processing instructions, kit contents, shipping conditions and logistics
Furthermore ,our qualified team oversee outsourcing to third parties and vendor management of specialty lab vendors for biomarker assays and manage timelines for sample testing and data transfer with external vendors , as well as transfer/discrepancy resolution with central lab .
We are able to provide sample collection and assay status updates with high level metrics provided to Biomarker project managers within your companty at any stage/milestone.