BioFortis
A Data-Driven Approach to Streamlining Clinical Trial Samples

Clinical trials can be envisioned as an ecosystem of laboratories, vendors, and biobanks knitted together by patient samples and data. Tracking patient samples and consent across this highly complex clinical trial network can be incredibly challenging. Studies, especially those pertaining to precision medicine, must manage specimens and associated data throughout their lifecycle, from initial patient consent to final delivery of formatted information. As such, consent tracking has become an indispensable functional layer that sits atop of sample management. In the past, it may have been relatively easy for study teams and data/specimen managers to keep track of ‘where’ samples are and ‘how many’ are in use. However, in today’s trial landscape, knowing what procedures can be executed against a sample across its clinical trial journey is beyond the scope of localized spreadsheets and homegrown tools. It is imperative that trials adopt a highly integrated approach toward Clinical Trial Sample and Consent Tracking (CTST) to support total sample lifecycle management.

This is where BioFortis, a Q² Solutions company, is moving the needle. The company offers Labmatrix^®, a web-based biobanking and CTST solution that provides a 360-degree view of biospecimen data across clinical trial phases and locations. Labmatrix^® is a configurable CTST system that provides comprehensive sample lifecycle support for in-study sample and consent management and tracking, including next-generation biobanking and data mining.

The next-generation clinical and translational research management solution seamlessly facilitates the management and integration of patient, clinical, specimen, genetic, and molecular assay data. This eliminates impediments associated with managing biospecimen data that has historically brought about plenty of confusion within trials, costing time, money and hampering the timely entry of life-saving drugs and treatments to the market.

End-to-End Clinical Trial Sample and Consent Tracking

“Today’s precision medicine clinical trials are a distributed ecosystem of a number of interactive members that depend on and support each other as the samples move from place to place. To this end, our solution aims to enable collaboration and facilitate the seamless and secure flow of information, which ultimately drives efficiency in trials,” says David Kaye, General Manager, BioFortis.

"We cater to several Top 10 and Fortune 500 companies engaged in the pharmaceutical industry"

Serving as a single platform for all sample-related data, Labmatrix^® accurately pairs patient consent data with the sample/ biospecimen information in near real-time and in a centralized manner to ensure regulatory compliance and maintain the integrity of the entire ecosystem. Labmatrix^® can integrate sample data from the laboratory information management systems (LIMS), electronic data capture systems, biorepositories, and even shipping carriers via flexible API and system integration & standardization options.

Labmatrix’s data exploration tool allows all types of users to ‘ask’ sophisticated trial and biospecimen questions without the need for IT or programming skills. To facilitate high-level decision-making on sample resourcing, Labmatrix’s dashboard provides comprehensive insights into different aspects—reconciliation, summaries, projection, and consent. Organizations can create rich, integrated, and fully accessible ‘information hubs’ that provide a holistic view of research data. “Multiple reconciliation reports can be configured to show high level information, at the study- or site-level, or in more detail at the subject-level. The solution enables study teams to determine whether samples were collected as planned, if they were properly consented, if there were any unexpected samples, and even what samples are missing,” mentions David. Further, trial stakeholders get to accurately summarize what samples are currently available, where they are, which samples have been processed, and where they have been shipped. From a consent tracking standpoint, Labmatrix^® gives a clear understanding of what can be done with the samples, which samples would be impacted by the subject’s consent withdrawal, and when the samples would expire.

Multiple reconciliation reports can be configured to show high level information, at the study- or site- level, or in more detail at the subject level

In addition, users can even get projections on what kind of samples would be needed in the future, depending on the study. Study monitors, sample managers, and data administrators can leverage Labmatrix^® to quickly discover issues with the sample and minimize compliance risk—by site, by location, or across the entire study. When it comes to security and privacy, Labmatrix^® houses powerful access and security controls capable of influencing all data points pertaining to the biospecimens. User-defined roles and permissions can be easily assigned, giving every study stakeholder the relevant controls over what data elements can be shared and with whom.

As such, the scope of Labmatrix^® applies to the full spectrum of clinical studies, including biomarker/precision medicine studies that may have varied goals, data models, collaborators, and workflows. Labmatrix^® harmonizes biospecimens with clinical and molecular information in a holistic, secure, and compliant manner to ultimately enable multi-site, multi-investigator, collaborative studies.

In addition to Labmatrix^®, BioFortis also offers Qiagram^®, a purpose-built data exploration tool to make data more useful by making it smarter. Qiagram^® empowers researchers by providing an environment for “deep collaboration.” A web-based tool, Qiagram^® is powered by a new type of business intelligence (BI) technology, which replaces programming and other form-based query builders with a visual query “language.” As it guides the user through an exploratory process to get to the answers, the solution eliminates the need to understand the underlying data model or database concepts. Qiagram^® comes with a simple, secure interface providing a holistic view of data, which enables stakeholders in the research ecosystem to determine what data will be shared and with whom. Moreover, all queries developed using Qiagram^® can be shared with any of the researchers and informaticians involved in a project. As an ad hoc query search engine, Qiagram^®, in tandem with Labmatrix^®, proves to be an invaluable solution for the current big data era of clinical trials.

From Humble Beginnings to a Promising Future

Labmatrix^® was initially developed at the oncology department, Johns Hopkins University, to address the need for an ‘in-house’ system that allowed collaboration among researchers. Efforts to commercialize Labmatrix^® culminated in the inception of BioFortis, which initially positioned itself as a private company that catered to government agencies, including the National Institute of Health, and National Cancer Institute—the largest oncology research lab in the world today. Recognizing Labmatrix’s potential, Q² Solutions—a leading global clinical trial laboratory services organization—acquired BioFortis, and the rest, as they say, is history. “From there, we expanded to serve research organizations affiliated with universities. And once we established a strong client base, we began serving private industry. Today, we cater to several Top 10 and Fortune 500 companies engaged in the pharmaceutical industry,” notes David.

The client success stories that BioFortis have scripted with the prowess of Labmatrix^® best exemplify their value proposition. “BioFortis once identified mislabeled samples during our own internal quality checks that we perform before a study goes live in the Labmatrix system,” recalls David. The samples could have caused data anomalies that would otherwise have remained a mystery as the study progressed. In another instance, the study team of a large sponsor noticed that too many aliquots were being received from participants of two specific sample types, which implied that a lot of blood was being collected from them for an extended period. Upon further investigation, it was found that the study sites were using outdated sample collection kits. “After Labmatrix^® pooled all the sample data together, the team was able to see all of the samples at the aliquot-level and then make adjustments with the site to receive those updated kits,” mentions David.

In addition to serving clients in the CTST business, BioFortis also has several clients that use Labmatrix® across their research organization on a ‘platform basis,’ as Kaye mentions. This is because of Labmatrix’s capability to view data beyond the scope of sample and consent tracking. Interestingly, one of Labmatrix’s prominent users is Q² Solutions, BioFortis’ parent company. Q² Solutions is an internationally-recognized clinical trial laboratory services organization providing comprehensive testing, project management, supply chain, and short- and long-term biorepository and specimen management.

Going Beyond CTST - Supporting Q² Solutions’ Quest for Digital Innovation

Labmatrix^® and Qiagram^® have enabled Q² Solutions to create agile and impactful solutions across the organization with the underpinnings of traceability, productivity, quality, and efficiency. For instance, electronic sample processing instructions (ePROC) and electronic pathology report forms (ePRF) within Labmatrix^® have revolutionized the way Q² Solutions’ anatomic pathology (AP) team functions.

Q² Solutions’ AP services—entailing 130 tests, across five clinical labs, with over 100 global employees—could benefit from: a paperless workflow to manage studies in a 21 CFR Part 11-compliant system; direct electronic data capture with built-in validation checks to eliminate the most common data mistakes, avoiding manual data entry both onto and from paper reports, and simplifying the quality control (QC) process; and more efficient and transparent processes, allowing for real-time data entry and workflow management, as well as streamlined study monitoring.

“No off-the-shelf product can provide such a completely digitized solution with total flexibility and fully integrated workflows to capture vast amount of information on sample handling and processing, with the additional benefit of going completely paperless with pathologist reviews,” says David Mahshigian, Global Head of Marketing, Q² Solutions. This automation has eliminated manual data entry effort, reduced colored paper printing, paper archival resources, and storage cost of physical data.

Similarly, Flow cytometry represents one of the fastest-growing disciplines at Q² Solutions with 171 active assays, across seven clinical labs and over 130 global employees involved in the process. Flow cytometry data analysis requires extensive use of more than 100 validated MS Excel spreadsheets to calculate thousands of individual results for each patient sample. To this end, Labmatrix^® was configured to complete these calculations faster, eliminate manual calculation errors, create an electronic audit trail throughout the data review process, provide a real time QC monitoring solution, and replace all paper-based manual steps with electronic records. This automation project coincided with the company’s global implementation of the next generation flow cytometry Cytek^™ Aurora platform, which generates considerably more data than traditional flow cytometers. Apart from faster turnaround time, increased productivity with high-quality process automation has helped save paper equivalent to 44 trees annually.

Having carved a unique niche in the space, BioFortis aims to broaden the scope of Labmatrix^® to meet the evolving needs of trials. The company’s product management team, in this regard, constantly reaches out to clients and works closely with their sales team to keep the finger on the pulse of the market. “As our portfolio of clients grew, we got really rich inputs from many clients. This coupled with our market research, and more recently, being part of the Q² family has given us tremendous insight into the market and helped us develop our product roadmap,” concludes David.