Clinical Positioning
Clinical trials generate a range of biological samples with blood being the most common by far. Central labs are well equipped to manage blood samples. With increasing emphasis on tissue biomarkers (protein and RNA), frozen clinical tissue samples can become a component of a clinical trial protocol.
Frozen samples require a fundamentally different workflow. Clinical site personnel must be specially trained, and there must be active oversight of frozen tissue processing at clinical sites. Cold-chain logistics for frozen sample shipping must be tightly managed. This is where AGADA helps clients to excel.
Once the frozen samples arrive safely at AGADA, we follow extensive SOPs to generate both molecular and histological endpoints. We also handle aliquoting and outbound shipment to Sponsor designated molecular assay labs or other third-party vendors.
Our specialized experience provides assurance of critical data from frozen samples, whether for a primary surrogate outcome in support of accelerated approval, a pharmacodynamic biomarker, or an exploratory endpoint.
Frozen samples require a fundamentally different workflow. Clinical site personnel must be specially trained, and there must be active oversight of frozen tissue processing at clinical sites. Cold-chain logistics for frozen sample shipping must be tightly managed. This is where AGADA helps clients to excel.
Once the frozen samples arrive safely at AGADA, we follow extensive SOPs to generate both molecular and histological endpoints. We also handle aliquoting and outbound shipment to Sponsor designated molecular assay labs or other third-party vendors.
Our specialized experience provides assurance of critical data from frozen samples, whether for a primary surrogate outcome in support of accelerated approval, a pharmacodynamic biomarker, or an exploratory endpoint.