Labs / Central Laboratories / Biorepository Services

Biorepository Services

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 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.

Medpace Biorepository is a regulated facility that follows guidance from CAP, WHO GCP, GCLP, ISBER and NCI best practices and functions with the level of compliance for services spanning the clinical trial continuum (e.g., proof of concept/early phase through later clinical phase). 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 Medpace’s Clinical Pharmacology Unit (CPU) our biorepository also provides opportunities to establish prospective studies for acquiring specific specimens to answer early program decisions or gain insight into clinical trial subject stratification. Medpace Laboratories is an industry leader in terms of customized, high quality service for the pharmaceutical and biotech clinical development industries.

Biorepository Highlights

  • A CAP accredited facility
  • Extensive capacity and global scalability in state-of-the-art facilities
  • Over 19,000 SF Sample Management space (US, EU, Singapore & China)
  • High quality processes with expertise supporting therapeutically-focused studies for oncology, cardiovascular, CNS, and metabolic clinical research
  • Ambient, 4°C, -20°C, Ultralow (i.e. -70°C/80°C), & Liquid Nitrogen storage capabilities
  • Storage includes but is not limited to serum, plasma, whole blood, urine, DNA, RNA, PBMC, PK, FFPE/slides-blocks, bone marrow, cells and pellets, CSF, teeth, stool and research biomaterials
  • Procedures follow CAP, ISBER Best Practices for Repositories and NCI Best Practices for Biospecimen Resources
  • Secured access
  • Continuous 24/7 temperature monitoring with alarms and text/email alerts
  • Backup generators and full business continuity plan
  • Powerful database for fast and efficient sample positioning and retrieval
  • Use of cryogenics for shipping and receiving temperature critical biomaterials (e.g., cells, research product, etc.)
  • Flexibility to manage study-specific processing including aliquoting, buffering, relabeling, and de-identifications
  • Medpace provides comprehensive solutions for relocating your clinical specimen collections
  • Real-time global tracking and tracing of specimens
  • Subject matter expert in biorepository field
  • High quality processes with expertise supporting therapeutically-focused studies for oncology, cardiovascular, CNS, and metabolic clinical research

Resources

Biorepository Services

Fact Sheet: Biorepository Services

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