Almac

The setup of the biomarker component of a clinical trial is an important consideration and must be planned carefully.
The services we offer include;

• Requirements gathering and SOP development
• Operational manual development
• Site training
• Site audits

Requirements must be gathered regarding shipping logistics, regulatory requirements and international challenges. Supporting documentation must be developed including trial specific standard operating procedures, test request forms and operational manuals.  While sample handling may be fairly routine in most sites, dependant on the test to be delivered, there may be assay specific requirements. We will develop the operational manual and train the sites on the sample collection specific for the assay. We can then carry out audits of the clinical sites.

For further information click here to contact us.