An Integrated Approach to Support a 510(k) Submission

Versiti held multidisplinary meetings with the client to understand the project scope in order to design the bestsolution. Having a centralized partner providing project management and a comprehensive suite of specialtyservices allowed the client to complete their project sooner than outsourcing each element individually. Through these conversations, it was determined the client needed:

• Assay development and execution
• Central laboratory services
• Biomaterials for research

Versiti shared its suite of capabilities to meet the project’s scope and build a trustworthy partnership with theclient. We were able to learn and execute the client’s device process quickly.

The Versiti team built a customized testing solution for the client. The following services were provided:

• Project management, including leading study meetings
• Study and data management, including comprehensive and customized study report
• Development and execution of new tests, including procuring specific reagents and developing uniquemethodologies for hemoglobin and hematocrit testing
• Comprehensive testing services throughout the study, including hematology and coagulation testing
• Shipping and logistics

Versiti is the largest independent blood bank in the upper Midwest. The provision of products for this project did not impact Versiti’s ability to serve the transfusion medicine needs of the communities we serve. To support this client, we prepared and provided the following products to validate testing, which required a specialized process that involved testing products from specific collection time points:

• Fresh frozen plasma
• Packed red blood cells
• Platelets
• Whole blood

Versiti’s ability to provide assay development, customized testing, and blood products for research, in thecorrect regulatory environment, led to significant time savings for the client. The client did not have to contractwith multiple providers because of the integrated service efficiencies Versiti could provide, which was criticalgiven the deadline for FDA submission. The entire project from testing to completion was done in six weeks.This case example demonstrates how Versiti consults with partners to identify custom solutions tailored toeach unique project’s demands.

Versiti provides expert support for a diverse range of clinical trial needs. Our comprehensive approach includeslogistics, assay and biomarker development, IRB services, central laboratory services, blood products forresearch, and more. Our depth of expertise across the spectrum of blood health and clinical trials ensuresnimble, high-quality, efficient and reliable results. We are your partner throughout every stage of your clinical oracademic research.

To learn more about Versiti’s clinical trial services and biomaterials for research, visit versiticlinicaltrials.org, or contact us at clinicaltrials@versiti.org.