Clinical Research
Your Clinical Trial Samples:
Visible. Compliant. Ready for Whatโs Next.
GCP compliance gets you inspection ready. Lifecycle intelligence gets you optimized for the decades that follow. GXP-Storageยฎ delivers both โ purpose-built clinical storage with the visibility to manage your biospecimen portfolio across its full retention lifecycle (not just during active trials). We serve multinational sponsors across the Americas and EMEA from strategic locations in RTP and the UKโs Golden Triangle.
Problems That Compound Over Time
Left unaddressed, small gaps in how clinical materials are stored, tracked, and governed donโt stay smallโthey compound over time. What begins as minor inefficiencies can evolve into significant compliance risk, operational drag, and escalating cost.ย
Blind spots in custody. Siloed storage and disconnected record-keeping make a holistic view of your clinical materials โ and a defensible chain of custody across sites โ nearly impossible.
Post-study sample abandonment. Clinical samples are frequently left at CRO sites after study completion โ not by design, but by default. With no post-study lifecycle plan, samples accumulate in facilities designed for trial execution, not long-term regulated archiving.
CRO data silos. Your sample data lives in systems you donโt own. When a study ends or a CRO relationship changes, access to metadata, QC records, and chain-of-custody documentation becomes a negotiation.
The expertise gap. Building and managing a compliant multi-decade clinical research library requires specialized knowledge in GCP archiving, retention schedule management, and lifecycle governance.
Retention accumulation. Clinical materials don’t retire when trials end โ they stay for decades. Without lifecycle intelligence tied to regulations or business policies, costs compound indefinitely.
Your Trial Is Complete. The Lifecycle of Your Samples Has Just Begun.
Without a post-study lifecycle plan, most organizations end up in the same place: samples scattered across three or more CRO or lab sites, metadata trapped in systems they donโt own, QC issues they donโt know about, and storage fees they cannot easily interrogate. The โgood enough for nowโ solution becomes a compounding liability.
Leading bioanalysis frameworks and biorepository best practices are aligned: clinical samples should be consolidated into a purpose-built, GCP-compliant biorepository with end-to-end lifecycle management as soon as practicable after study completion. GXP-Storage does exactly that โ and we do the work.
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 Inventory Consolidation: Whether samples are distributed across two CRO sites or twelve, we manage transfer logistics, chain-of-custody documentation, and condition verification from every source location.
โข Metadata standardization and centralization: Ingest CRO LIMS exports, sample manifests, and QC records into GXP-Guardianยฎ and create a consolidated, accessible, searchable research library.
โข Regulatory-aligned retention management: Manage your retention schedule against regulatory event (not calendar year) โ alerting you when materials approach their obligation horizon and presenting disposition options.
โข Research-ready library creation: Create a library indexed for rapid retrieval and structured to support the retrospective analyses and AI-powered insights your research teams want to unlock.
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 GCP Research Library
GXP-Guardianยฎ aggregates your physical sample inventory and harmonizes the related data โ CRO LIMS exports, lab manifests, QC records, retention schedules, chain-of-custody documentation โ from every source into a single regulatory-compliant platform. Whether materials are held at our American or UK sites, you see one harmonized, audit-ready research library in a single interface.
Complete Clinical Material Management
- Investigational Medicinal Products โ Received, logged, and stored under validated conditions from IND-enabling studies through post-marketing commitments โ with chain-of-custody that never resets at a phase boundary.
- Biological Samples โ Blood, plasma, serum, and tissue managed with compliant preservation, QC at receipt, and aliquot tracking โ sample integrity documented from collection through final disposition.
- Clinical Documentation โ Regulatory files, trial master files, and site documentation archived in a validated and 21 CFR Part 11-compliant system โ retrievable in minutes for inspection, submission, or business development.
- Legacy Sample Consolidation โ Receipt and integration of samples currently fragmented across CRO sites, central labs, and third-party facilities โ with independent QC, re-indexing, and lifecycle management from day one.ย
Value Across the Full Clinical Lifecycle
- Trial execution continuity. Real-time inventory management prevents trial delays due to stockouts. Phase transitions without vendor changes eliminate transfer risk and chain-of-custody resets.ย
- Post-study library management. Study completion is not the end of your sample lifecycle obligation. GXP-Storage manages retention schedules based on your requirements, triggers disposition when obligations are met, and prevents the silent cost accumulation of abandoned CRO samples.ย
- Audit-ready at any moment. Complete chain-of-custody documentation, temperature logs, and QC records retrievable in minutes โ not assembled in the days before an inspection.
- Research library as strategic asset. A consolidated research library accelerates your next study. Reusable samples reduce future collection costs. Standardized metadata enables retrospective biomarker analysis. Your history becomes your competitive advantage.
- Partner ecosystem proximity. Strategic positioning near leading CRO and analytical laboratory partners reduces transit time, transfer risk, and inter-provider coordination overhead.
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.
Your Clinical Research Library Is An Asset. Manage It Like One.
Every sample your organization has ever collected represents a scientific decision, a regulatory commitment, and a potential future insight. When fragmented across CRO sites, trapped in systems you donโt control, or accumulating in facilities not designed for regulated life science materials, your assets become liabilities.
From Operational Burden to Strategic Advantage
It doesnโt have to stay that way. Transform your clinical research library into strategic advantage by consolidating your materials, data, and chain of custody into one continuous, controlled lifecycle that enables your archive to work for you โ not against you.
To learn about how we can help you manage your Clinical Research Library, download our information sheet.