Preclarus lab data ecosystem: Delivering complete visibility and confidence across every lab partner

A connected foundation for global clinical laboratory operations

In the complex world of clinical trials, seamless data exchange and traceability across multiple laboratory partners are essential. Yet, once samples leave a site, visibility often isn’t a given. Tracking samples from the point of collection through the entire life cycle has historically been difficult, and it is important for study teams to access details and information within a study in real time. Data disperses across systems, chain of custody becomes harder to demonstrate, and study teams spend valuable time reconciling information instead of making decisions. This is not simply a reporting challenge — it is an operating model challenge.

Rather than cross-checking multiple databases, a single source of truth saves study teams time and improves efficiency. Our central lab delivers that visibility and control. Study teams need real-time access to comprehensive study data in one place — a single, accountable source of truth — rather than stitching together fragmented systems. Preclarus™ Laboratory solutions provides this full visibility.

The Preclarus technology ecosystem is the digital backbone that ensures every sample, workflow, and data point moves through a controlled, compliant, and fully transparent life cycle. Purpose-built to support complex global clinical trials, this platform integrates laboratory operations from end to end — empowering investigator sites, sponsors, and third-party laboratories with the real-time visibility, governance, and quality controls required for modern studies.

A dedicated third-party lab interface within Preclarus enables direct sample accessioning, facilitates query resolution via Site Support Services, and supports the upload and ongoing update of results — ensuring external data is captured within a unified, controlled framework.

A single source of truth built for scale, control and compliance

At the core of this ecosystem is our custom Laboratory Information Management System (LIMS) Preclarus central lab database. Rather than relying on disconnected databases and point solutions, our LIMS establishes a unified operational infrastructure. This single, validated environment standardizes how samples are received, routed, tested, stored, and reported. Engineered in-house, it drives all operational processes:

• Scanning and accessioning samples at receipt
• Managing routing across analytical labs
• Coordinating outbound transfers to external labs
• Tracking storage
• Generating results
• Feeding downstream workflows such as finance and kitting

The result is more than connectivity. The Preclarus infrastructure provides a standardized, validated operational model that ensures accuracy and compliance across our global network. This reduces reconciliation effort, accelerates insight and restores confidence across the entire laboratory data life cycle.

Specialized components driving visibility

Several specialized components further extend this visibility:

Sponsor portal

• Virtual biorepository (VBR): A real-time global view of every sample’s location and detailed chain-of-custody history, including storage metadata and event-level traceability.
• Custom reporting engine: A flexible, sponsor-driven analytics environment where users choose their own fields, formats, and outputs — enabling tailored reporting and rapid data extraction for any operational or scientific need.

Investigator site portal

• The first external extension of the Preclarus suite, this portal enables sites to maintain high-quality, compliant sample collection and shipment processes through electronic requisitioning, shipping tools, query management, kit ordering, results access, critical alerts, and daily operational reports. Built-in protocol validations help prevent errors before samples ever leave the site.
• Mobile companion application: Designed to reduce barriers to adoption, the mobile app delivers the full functionality of the site portal on phones and tablets — allowing sites to manage workflows anywhere in the clinic.

Together, these components create the unified digital foundation that enables operational excellence, transparency, and accountability across central labs, investigator sites, and global study partners. It is on this foundation that the Preclarus third-party lab portal extends the ecosystem to external labs — ensuring that samples processed outside the central lab network receive the same level of visibility, quality and chain-of-custody rigor.

Empowering sponsors with complete visibility across every lab partner

When sponsors collaborate across multiple labs — central labs, regional labs, and third-party labs — every additional partner increases the challenges of maintaining visibility, compliance, and data integrity. Without a unified ecosystem, visibility breaks down, compliance becomes harder to demonstrate, and manual reconciliation slows decision-making. The Preclarus Lab Data Portal is designed to address this head-on, providing end-to-end transparency and control across the entire sample life cycle, even when data originates from laboratories outside our direct network. Sponsors gain a single, connected view of their study’s laboratory ecosystem, regardless of how many external labs are engaged or where they operate globally.

Unmatched flexibility for every third-party lab relationship

What sets the Preclarus Lab Data Portal apart is its third-party lab portal and ability to integrate laboratories without requiring pre-existing contractual relationships or lengthy IT onboarding. The platform supports:

• Direct third-party portal access for shipment check-in and results upload
• Flexible file uploads, accommodating virtually any Excel format with minimal mapping
• System-to-system APIs for fully automated data exchange with labs that have their own LIMS

This allows sponsors to bring any third-party lab into their workflows from day one without operational disruption.Regardless of integration method, all data flows through the same validated, controlled framework, ensuring consistent quality, traceability, and compliance.

Built-in chain of custody and quality controls to ensure confidence and reliability

At every stage, Preclarus safeguards sample integrity and regulatory compliance. When sites create electronic requisitions and shipments, Preclarus validates temperature requirements, destinations, and protocol rules, reducing errors before samples ever leave the site. Once in transit, sponsors have real-time visibility into chain-of-custody milestones, shipping conditions, and quality-control checkpoints.

Third-party labs can document temperature deviations, labeling issues, leaks or other discrepancies directly in the portal. These issues route automatically to Global Site Services for standardized, transparent resolution across all partners.

These standardized workflows provide real-time visibility, eliminating side emails, manual trackers and inconsistent follow-up — strengthening both operational control and audit defensibility.

End-to-end transparency for sponsors

Preclarus delivers actionable insights by structuring and visualizing raw data through configurable dashboards. Sponsors can monitor sample distribution, shipment status, and testing progress in real time, and view full sample history and chain-of-custody, associated test results, and shipping and condition logs. All grids and visualizations can be filtered, saved, or exported — supporting operational clarity and audit readiness at any moment. By replacing fragmented reporting structures with a unified source of truth, sponsors reduce reconciliation burden, minimize communication gaps and maintain continuous control across every laboratory partner.

Why sponsors using multiple labs choose Preclarus

Sponsors have several reasons for choosing Preclarus. These include:

• Universal connectivity – Integrate any third-party lab worldwide.
• End-to-end visibility – Track every sample from collection to final result.
• Regulatory confidence – Maintain documented, compliant chain of custody.
• Operational efficiency – Streamline onboarding, communication and reporting across study partners.

By unifying all laboratory data flows — central and external — Preclarus enables sponsors to move faster, with greater accuracy and complete confidence in every data point.

The future of connected laboratory data

As clinical trial networks grow more complex,fragmented systems can no longer properly support the demands of modern studies. Every partner, process, and sample must be connected, governed, and transparent by design.

Preclarus provides that foundation across lab partners — redefining the operating model for global lab data and delivering a single, validated ecosystem where visibility is continuous, compliance is embedded, and confidence is built in from the start.