Hematogenix offers a comprehensive array of services designed to navigate the complexities of human subject clinical trials. Our deep research and clinical laboratory experience enable us to resolve emerging challenges found in clinical trials. Hematogenix provides logistic management of tissue and sample procurement, distributes collection kits and contributes to standards and procedures required for initiating a clinical trial. Powered by a state-of-the-art laboratory information system, Hematogenix facilities and practices comply with rigorous chain of custody and specimen management practices. We are a CAP, CLIA and GCP compliant laboratory.
Hematogenix welcomes the opportunity to interact with your teams to customize and improve its quality processes and services. Contact our Director of Quality to schedule an audit.
The specimen gathering and testing requirements will be consolidated into a Scope of Work document. The Hematogenix Project Manager and System Administrator will translate these parameters into a project specific database and validate it.
Specimen Collection Kits
Hematogenix can receive collection kits from CROs or provide collection kits for fresh and archival material. Hematogenix can deliver collection kits to sites, monitor expiration dates and send replacement kits. Specimen collection kit inventory and its components are tracked remotely and automatically through Hematogenix LIMS.
Our project managers have direct experience with US and global clinical trials. The Project Manager will serve as your point of contact and is also responsible for handling the queries from clinical sites, CROs and third party laboratories.
Chain of Custody
Upon arrival at Hematogenix, all specimens will be tracked through our state of the art LIMs. The location of specimens, whether in storage or mid-process, is available in real time. Hematogenix technicians scan specimens utilizing barcoding stations at designated laboratory and storage areas.
Real Time Status Updates
Sponsor project managers can query Hematogenix LIMs for project specific information such as the number of specimens received and testing status through a password protected and encrypted secure site. Hematogenix System Administrator can assign access rights per the instruction of sponsor project manager.
Biomarker and testing data can be transferred through standardized electronic data protocols. Hematogenix System Administrator will configure data portals per sponsor specification and format.
Digital Image Capture & Retrieval
For security and convenience, Hematogenix captures and archives high-resolution images of specimens. These images are accessible via password protected and secure access and can be assembled for web conferences.
Specimen Storage & Management
The Hematogenix LIMs provides real time chain of custody for your specimens. Specimen storage areas are humidity and temperature-controlled with three tiers of security access and video surveillance.
The Hematogenix tissue bank and specimen storage areas meet ISBER standards.