Pre-Clinical Research
Build a Pre-Clinical Research Library That Works for You
Problems That Compound Every Year You Wait
Storage challenges compound over time, increasing cost and risk the longer they go unaddressed. What starts as fragmentation quickly leads to compliance exposure, slow retrieval, and unnecessary spend.
Blind spots in custody. Siloed storage and disconnected record-keeping make a complete view of your GLP study materials โ and a defensible chain of custody โ nearly impossible.
The compliance tax. Managing materials across multiple providers is expensive and audit vulnerable. Every additional vendor multiplies your exposure.
Retrieval paralysis. When a partner or inspector requests a study package, your team is left hunting across fragmented systems โ costing you time.
Manual retention schedules in spreadsheets. Automated lifecycle intelligence tied to regulatory event โ disposition when the obligation is met, never before, never years after.
GLP Archiving Handled So Your Team Can Focus on the Science
Pre-clinical teams consistently face two compounding challenges: fragmented supplier coordination that makes tracking materials across providers difficult, and a quiet buildup of obligation as samples and records disperse across CROs, labs, and storage systemsโoften without consistent oversight or auditable controls. GXP-Storageโs integrated lifecycle approach eliminates these friction points, replacing fragmentation with a single, accountable framework.
GXP-Storage takes full responsibility across the lifecycle. At your direction, and in full compliance with 21 CFR Part 58, OECD and GLP regulations, we provide:
โข Centralized physical and electronic records archiving: Ingest, structure, and register your complete study archive โ spanning both physical specimens and electronic records โ into a single, audit-ready platform.
โข End-to-end material integrity control: Maintain material integrity across all required temperature conditions โย controlled ambient to cryogenic โย with continuous environmental monitoring and validated chain-of-custody at every stage.
โข Regulatory-aligned retention management: Manage your retention schedule against regulatory event (not calendar year) โย alerting you when materials approach their obligation horizon and presenting disposition options.
โข Rapid, on-demand study retrieval: Retrieve and deliver complete study packages on demand โ in hours, not weeks โ for audits, regulatory submissions, out-licensing, or business development.
โข Archive rationalization and risk reduction: Consult on how to rationalize inherited archives from acquisitions, program transfers, or legacy CRO relationships โ turning unknown liabilities into known, manageable assets.
PURPOSE-BUILT FACILITIES
Our purpose-built, commissioned facilities with secure access-controlled environments provide millions of cubic feet of storage capacity across controlled ambient to cryogenic conditions that grow with you from discovery through development.
FULL VISIBILITY
Research materials and documentation can be visible through our proprietary GXP-Guardianยฎ, the only system explicitly built for regulated material lifecycle management supported by a complete digital architecture.
CERTIFIED SOLUTIONS
From your first research sample to the day your commercial product ships globally, you maintain full visibility and control through a single, GAMP 5 and 21 CFR Part 11 validated system. Generate compliance documentation quickly. This is what industry leadership looks like.
One Federated View of Your GLP Research Archive
GXP-Guardianยฎ aggregates your complete pre-clinical research library โ physical specimens and electronic documentation โ from every CRO, analytical lab, and storage site into a single regulatory-compliant system. Whether materials are held at our American or UK sites, you see one harmonized, audit-ready research library in a single interface.
Complete GLP Material Custody
- Pre-Clinical Test Articles โ Stored across all required temperature conditions โ with retention schedules tied to regulatory events.
- Temperature-Critical Specimens โ Tissues, organs, and diagnostic samples with validated environmental monitoring and automated excursion alerts.
- Study Documentation โ Protocols, final reports, and amendments archived in 21 CFR Part 11-compliant systems โ indexed for expedient retrieval, audit-ready by design.
- Wet Tissue, Blocks & Slides โ Optimized environmental controls with lifecycle intelligence that identifies when retention obligation is met โ preventing indefinite accumulation.
- Reference Standards โ Complete characterization documentation with chain-of-custody tracking from receipt through expiry or disposition.
A Growing Global Network. Positioned Where You Operate.
GXP-Storage operates a growing network of international regulated material management sites in key geographies โ strategically located near major life sciences clusters, manufacturing facilities, and multimodal logistics infrastructure.
AMERICAS (US โ Research Triangle Park Region)
- Primary consolidation hub for the Americas region
- Foreign Trade Zone 214 โ duty deferral and customs efficiency for imported APIs and materials
- Port of Wilmington & Morehead City โ deepwater East Coast seaport access
- Raleigh-Durham International Airport โ air cargo with nonstop routes to London and Paris
- Carolina Connector rail intermodal terminal โ road/rail/port connectivity
- I-95 & I-40 โ full Eastern Seaboard and U.S. interior access
EMEA (UK โ Golden Triangle Region)
- Heart of the UKโs Golden Triangle โ direct access to Oxford, Cambridge, and London life sciences corridors
- Port of Felixstowe โ UK’s largest container port handling 40%+ of containerized trade
- London Heathrow & Stansted โ air cargo with nonstop routes to global pharma hubs
- Heathrow & Stansted airport proximity โ direct air freight to global hubs
- East West Rail corridor โ emerging Oxford-Cambridge connectivity
- M1, M11 & A1(M) motorway access โ full connectivity across England and to major ports
Built for Regulated Materials From the Ground Up
GXP-Guardianยฎ is not a warehouse management system with a reporting module. It is not a LIMS with a storage add-on. It is the first digital-native platform purpose-built to consolidate regulated physical material and harmonize all related data into a single regulatory-compliant platform.
The Results:
Visibility & Control: A single, searchable view of every item across your research library. Know exactly what you have, where it is, and its condition โ One Federated View.
Regulatory Confidence: One immutable chain-of-custody from receipt through final disposition โ 21 CFR Part 11 and Annex 11 compliant. Inspection-ready at any moment.
Unified, AI-ready system of Record: One AI-ready system of record, standardized across every source โ the data foundation your analytics strategy requires.
Data Centralization: Sample metadata, storage conditions, and disposition history unified in GXP-Guardian. No more reconciling spreadsheets, LIMS exports, and CRO manifests.
ISO 9001:2015-Certified: Quality management system independently verified โ governing every storage and retrieval process your materials experience.
ISO 20387:2018-Certified: Biobanking management system independently verified โ governing specimen integrity, traceability, and chain of custody from receipt to retrieval.
Enterprise-Grade Platform: ISO 27001/27017/27018-certified for data security, SOC 1/2/3-certified for operational and financial controls, and FedRAMP-ready for government and highly regulated enterprises.
Not All Storage is Equal
The Risk Is Real. The Remedy Is Straightforward.
If your pre-clinical research library or GLP study documentation is housed in a facility not purpose-built for regulated materials, itโs time to consolidate and eliminate hidden costs.
To learn about how we can help you manage your Pre-Clinical Research Library, download our information sheet.