Research Services

Biomedical specimens storage deserves better! And so it was, in 2000, that Kate Grayson realized her vision to create the first-of-its-kind business dedicated exclusively to the storage of biomedical specimens, offering its expert services to pharmaceutical companies, laboratories, biotechnology companies, contract research organizations (CROs), research-dedicated sites, academic institutions, and US government agencies.

To Steelgate, providing these specimens with the highest level of care was paramount and a bold departure from what was typically seen as an ancillary - and often neglected - service subordinate to specimen analytics. Recognizing that these specimens held significant unrealized potential, Kate built Steelgate to help clients harness this potential by creating a state-of-the-art facility designed to provide short- and long-term storage of frozen and ambient specimens in an environmentally-controlled, secure facility.

Adhering to a core set of standard (and, as required, client-specific) operating procedures (SOPs) that rely on Good Laboratory and Good Manufacturing Practices (GLP/GMP) guidelines and are compliant with FDA’s Code of Federal Regulations CFR 21 Part 11 and Health Insurance Portability Accountability Act (HIPAA), Steelgate provides IATA-certified logistics management of in/out-bound specimen shipments. Steelgate’s proprietary database, STEELGATEdb is compatible with all Laboratory Information Management Systems (LIMS) software and highly flexible to meet diverse client demands for customized data collection, mapping of field headings and reporting. Steelgate’s Quality Assurance/Quality Control (QA/QC) protocols require two-tiered double data entry for 100% of client specimens inventory.

As a client-focused business, Steelgate offers both standard and customized solutions that include:

  • Project management

  • Liaison between/among clients, laboratories, investigational sites, CROs or third-party biorepositories

  • On-site specimen inventory management, packing and relocation

  • dedicated freezers restricted to single-client use only

  • Transport logistics (in/outbound) working with client preferred vendor(s)

  • Consulting in support of all areas of specimen retrieval, storage and inventory management

IMPORTANT HIGHLIGHTS OF STEELGATE’S OPERATION

  • All freezers NIST-certified/calibrated and subject to semi-annual preventive maintenance

  • Multi-unit generators providing primary and redundant back-up power supply to entire facility (tested weekly)

  • All HVAC and Generator units subject to regularly-scheduled preventive maintenance

  • Standby/back-up active freezers run in parallel with primary storage freezers

  • Freezer-dedicated temperature and power alarms monitored 24/7/365

  • Twice-daily physical inspection of all freezer temperatures

  • Facility ambient temperature sensors

  • Fire, smoke and water sensors

  • Rubber flooring throughout specimen handling areas

  • Perimeter lightning diffusers

  • CCTV surveillance - interior and exterior

  • Motion-activated intruder alerts and audio sensors

  • 24-hour central station monitoring for all alerts/alarms

  • Real-time daily data back-up to offsite/cloud storage

  • Annual disaster preparedness test including on-site participation of all critical vendors (Generator, H.V.A.C., IT and Freezer Maintenance)