LabConnect Upgrades Clinical Trial Logistics with SampleGISTICS 2.0

RALEIGH, N.C. – March 31, 2026 – LabConnect, a global provider of central laboratory services, today announced a significant modernization of its clinical trial sample management with the launch of SampleGISTICS® 2.0. The new smartphone-based application is designed to digitize sample capture at the collection point, replacing the company's long-standing digital pen technology and addressing persistent logistical hurdles that can delay critical medical research.

For years, the clinical trial industry has grappled with the challenges of sample management, including paper-based requisitions, error-prone manual data entry, and fragmented courier processes. These issues often lead to lost or misidentified samples, costly shipping delays, and a lack of real-time oversight, creating bottlenecks in the drug development pipeline. LabConnect's new solution aims to resolve these problems by leveraging ubiquitous mobile technology to create a seamless, integrated, and transparent workflow from the clinic to the laboratory.

Beyond the Digital Pen: A Leap in Clinical Trial Logistics

The launch of SampleGISTICS® 2.0 marks a pivotal technological shift for LabConnect and its clients. The company is moving away from its previous digital pen system, a technology that, while innovative for its time, represented a semi-digital bridge between paper forms and electronic data. The digital pen captured handwriting on special paper forms and required docking to a USB port to transmit the encrypted data. While it improved upon purely manual methods by providing near real-time data submission, it was still dependent on physical media and subject to potential technical issues like software compatibility and character recognition errors.

SampleGISTICS® 2.0 replaces this system with a fully mobile application available on standard smartphones and tablets. This evolution empowers clinical research site staff with a more intuitive and powerful tool. Key features include:

• Barcode Scanning: Enables precise sample identification directly at the point of collection, minimizing the risk of human error associated with manual labeling.
• Guided Workflows: The application guides users through study-specific protocols, ensuring proper procedures are followed and the correct collection kits are used, thereby enhancing protocol compliance.
• Offline Functionality: Recognizing that clinical sites operate in diverse environments with varying levels of internet connectivity, the app can function offline, capturing data that syncs automatically once a connection is re-established.
• Multilingual Support: To accommodate the global nature of modern clinical trials, the application supports multiple languages, providing a localized and user-friendly experience for site staff around the world.

"SampleGISTICS 2.0 is the result of our more than two decades of experience managing decentralized clinical trials across our global network of laboratories, couriers and operations," said Wes Wheeler, chief executive officer of LabConnect. "That level of expertise and integration made it possible to develop a new application designed specifically for clinical trials by digitizing sample capture at the collection point."

Real-Time Data: Accelerating the Path from Collection to Cure

A core advancement of SampleGISTICS® 2.0 is its ability to provide true real-time visibility into the entire sample lifecycle. Unlike previous workflows that relied on periodic status updates after data was uploaded, the new application transmits information instantly. This creates a continuous data stream, allowing sponsors and contract research organizations (CROs) to monitor a sample's location, status, and stability from the moment it is collected until it is received by the laboratory.

This immediate traceability has profound strategic implications. Real-time data allows for proactive management rather than reactive problem-solving. For instance, logistics teams can identify and address potential shipping delays before they become critical, and labs can get advance notice of incoming samples.

"By leveraging technology to streamline data capture at the site, we can significantly reduce queries and gain visibility into samples arriving close to expiration windows that require priority processing," explained Charles Castano, chief technology officer at LabConnect. This capability is crucial for time-sensitive or temperature-sensitive biologics, where even a short delay can render a sample unusable.

By reducing data entry errors, ensuring proper kit usage, and providing immediate sample traceability, the system is designed to support faster and more reliable laboratory results. This acceleration at the operational level can have a cascading effect, potentially shortening overall clinical trial timelines and helping to bring new therapies to patients more quickly.

Navigating a Competitive Digital Landscape

The introduction of SampleGISTICS® 2.0 arrives as the entire clinical research industry undergoes a rapid digital transformation. The COVID-19 pandemic accelerated the adoption of technologies that support remote and decentralized clinical trials (DCTs), and the market for eClinical solutions is increasingly competitive. Major CROs and specialized technology vendors are all vying to offer platforms that promise greater efficiency and data quality.

In this environment, LabConnect's launch is a strategic move to solidify its position as a key infrastructure provider. By developing a purpose-built mobile solution that integrates tightly with its core central laboratory services, the company enhances its value proposition. The platform's design, informed by extensive experience in DCTs, makes it particularly well-suited to the complex logistics of collecting samples from patients in various settings, including their own homes.

Ensuring Integrity in a Validated Environment

Perhaps the most critical aspect of the new system is its secure integration with LabConnect's "validated LIMS environment." In the highly regulated world of pharmaceutical development, this is not a trivial detail. A Laboratory Information Management System (LIMS) used for clinical trials must be "validated" to prove it operates reliably and in compliance with strict regulatory standards, such as Good Clinical Practice (GCP) and the FDA's 21 CFR Part 11.

This regulation governs the use of electronic records and signatures, ensuring they are as trustworthy and legally binding as their paper counterparts. Compliance requires features like secure, time-stamped audit trails that track all data changes, robust security protocols to prevent unauthorized access, and documented proof that the system performs as intended. By securely transferring data directly from the point of collection into this validated environment, SampleGISTICS® 2.0 bypasses manual data re-entry at the lab, a major source of potential errors.

As described by the company's CTO, Charles Castano, the application "simplifies how sites handle study visit and participant data at the point of collection, securely transferring it into LabConnect's validated LIMS environment." This focus on regulatory compliance and data integrity is essential for ensuring that the data collected can be trusted for pivotal regulatory submissions, underpinning the safety and efficacy of new medical treatments.