High-Quality Specimen Management

Medpace recognizes that translational medicine is driving an evolution in sample management and that samples are highly strategic assets. Biorepositories are a critical component of any clinical study, given the need for the highest quality specimen management. Therefore, the focus should be on comprehensive sample management solutions and not only the storage of samples. Key biorepository capabilities must include robust, quality processes for sample handling, storage, and tracking. Scientific expertise is a critical aspect of these project teams.

Comprehensive Sample Management Solutions – Not Just Storage

Medpace Biorepository is a regulated facility that follows essential guidance and industry standards from agencies around the world. The agencies include the College of American Pathologists (CAP), the World Health Organization Good Clinical Laboratory Practices (WHO GCLP), International Society for Biological and Environmental Repositories (ISBER),  and the National Cancer Institute (NCI) best practices. Our biorepository functions with the level of compliance for services spanning the clinical trial continuum (e.g., proof of concept/early phase through late stage). Medpace Biorepository Services offers solutions for comprehensive specimen life cycle management, which can begin with providing sample collection kits to sites through to receipt, processing, storage, retrieval, and destruction.

In cooperation with the Medpace Phase I Unit, we provide opportunities to establish prospective studies for acquiring specific specimens to answer early program decisions or gain insight into clinical trial subject stratification. Medpace Central Laboratories is an industry leader in terms of customized, high-quality service for the pharmaceutical and biotech clinical development industries.

More Than Just a Biobank

A biobank is a type of biorepository, which typically stores only human biological samples. A biorepository, such as Medpace, is more inclusive and refers to the storage and management of specimens from animals, humans, and many other living organisms. Medpace not only has biobanking capabilities but also handles a variety of biospecimens for every stage of clinical development or academic needs.

Biorepository Highlights:

  • CAP-accredited
  • Procedures follow ISBER and NCI Best Practices
  • 24,000+ SF global Sample Management space
  • Real-time global tracking and tracing of specimens
  • Continuous 24/7 temperature monitoring with alarms and text/email alerts

Sample Processing

Medpace Biorepository also processes samples in a variety of ways including purifying whole blood and bone marrow for mononuclear cells, aliquoting, card spotting, buffering, acidifications, deidentifying/relabeling, etc. Other processing methods can be added customized per request.

Our peripheral blood mononuclear cell (PBMC) processing procedures are certified annually through an external Biospecimen Proficiency Testing Program in cooperation with the Integrated Biobank of Luxembourg (IBBL). This program compares our performance to other laboratories using these criteria: viability, cell yields, and functional performance in IFN‐gamma ELISpot assay.

Additionally, our Sample Processing technicians are qualified by a top 5 Pharma company for processing PBMC for use in their critical, clinical programs. This qualification was based on meeting their criteria for viability, cell yields, and functional performance in IFN‐gamma ELISpot assay.

This article is excerpted from Medpace

Leave a Reply

您的电子邮箱地址不会被公开。 必填项已用 * 标注

Related Post