The Sample Collection Manual provides biological sample collection, processing, storage and shipping procedures for assays mandated by the study protocol. Prior to preparing the manual, KCAS reviews the protocol and works closely with the Sponsor to establish the manual requirements. All manuals are reviewed by the Sponsor and where applicable, other partnering CRO(s) managing the clinical sites, prior to issuing the final document.
Sample kit (SK) team members have worked in clinical settings and thus have real-life knowledge of sample processing techniques. With this experience, they work with the Sponsor to provide easy to read instructions on how to collect and process the various matrices. SK team members are all IATA Certified, therefore shipping instructions located in the manual are updated to reflect current shipping guidelines for the shipment of biological samples. The manual includes a simple supply re-order form and a template of the assay requisition or sample manifest to accompany samples during shipping. SK works with the analytical lab within or outside KCAS to detail any specialized collection materials and/or processing procedures needed to stabilize labile analytes or otherwise ensure sample integrity upon receipt at the analytical lab.
Getting the steps right the first time helps to guarantee the proper handling of a critical component (biological samples) within the clinical trial. Our goal is to not only provide kits/supplies to the clinical sites, but also to provide guidance to the clinician to help define the collection process that is outlined within the collection manual. We can attend Investigator Meetings either in person or via webinar to provide training to site personnel on the collection and processing of PK, biomarker or other samples in addition to providing a Sample Collection Manual.