The outcomes and accuracy of your research rely on the consistency of your clinical specimens – and the precision with which they are acquired, processed, stored, and handled.
At ProMedDx, we have biospecimen precision down to a science. Our experience in biospecimen collection, biostorage, and cold chain distribution has led us to develop and engage best practices and rigorous processes that preserve the viability and integrity of our biologics – and ensure that our clinical specimens comply with strict industry and government regulations. The outcome… high-quality, IRB-approved, and clinically annotated serum, plasma, whole blood, urine, and tissue materials that you can count on for all phases of your research.
Engage best practices and rigorous processes that preserve the viability and integrity of our biologics.
A Precise Approach
As an FDA-registered and inspected cGMP compliant blood establishment, we have established the reputation of a valued partner of life science researchers worldwide. To ensure that we meet the specific quality objectives of each of our clients, we have developed a clear and precise Quality System across all of our services and infrastructure.
Governed by stringent processes and managed by expert staff
- 75+ Standard Operating Procedures (SOPs)
- Quality Management Program (QSR, 21 CFR 820)
- Good Manufacturing Practice (cGMP)
- Biologics (21 CFR 606)
- Human cells, tissues, and cellular – tissue-based products (HCG/Ps; 21 CFR 1271 Subpart D)
- Good Laboratory Practices (GLP)
- 21 CFR 11-compliant Rockhopper™ data management system
- 21 CFR 11-compliant temperature monitoring system
- Certified Clinical Research Associates (CCRAs)
- Full-time quality assurance team, responsible for the monitoring and oversight of all clinical operations.
Security and Data Protection
Facility and Labs
- Individually coded and keyed access
- State-of-the-art security software
- Heat, smoke, and motion detectors
- 24/7/365 temperature monitoring
- Video surveillance and private 24-hour security patrol
Information and Data
- Active Windows domain policies
- Secure Web-based client portal
- Layered network firewalls
- Anti-virus gateways and clients
- Domain-integrated secure VPN access
- Data — Daily back-up, mirrored servers on-site with redundancy at off-site secure data center
Commercial and academic institutions across North America include ProMedDx as part of their business continuity plan. Our systems and infrastructure provide these clients with the assurance that their biologics are secured appropriately and safely in the event of an incident at their facilities.
As part of our commitment to these clients, we have undergone a risk assessment and have our own disaster recovery/business continuity (DR/BC) plan in place. To ensure the stability of the biospecimens and data at our facility, we have a trained emergency response team that is prepared to act immediately – and also have the following technologies and systems in place:
- Backup generators, UPS systems, and redundant HVAC systems
- Redundant freezers – at temperature
- Off-site mirrored servers and data replication
- Redundant ISDN connections: Internet and network
- Critical supplier resources – 24-hour response
- Temperature-controlled lab relocation services
Licensure and Best Practices
ProMedDx maintains certifications and follows best practices to ensure your biomaterials are received, stored, and shipped within full regulatory compliance:
- An FDA-registered blood establishment
- FEI #: 3002319730
- Rockhopper™ data management system and Amegaview temperature monitoring system
- US FDA Title 21 CFR Part 11-compliant
- International Society of Biological and Environmental Repositories (ISBER)
- Best practices for repositories
- National Cancer Institute
- Best practices of biospecimen resources
- International Air Transport Association (IATA)
- Certified shipper of infectious substances
- United States Department of Transportation
- Compliant shipper of infectious substances
Since 1998, ProMedDx has delivered the consistency and precision required to preserve the integrity and viability of clinical specimens – from collection through shipment. You can rely on ProMedDx expertise and standards for the compliant and viable biologics you need to support your research from discovery to diagnosis.