Q^² Solutions
A Leading Global Clinical Trial Laboratory Services Organization

Champions do extra. They sweep the sheds. They follow the spearhead. They keep a blue head. They are good ancestors”—an excerpt from author James Kerr’s book, Legacy. The inspiring book about the New Zealand national rugby team answers a fundamental question, “What is the secret to sustained success?” Being an avid Rugby fan and an ardent reader, Brian O’Dwyer, the CEO at Q² Solutions, has asked himself this question many times before he read the book.

The book gave O’Dwyer a unilateral conclusion: it’s all about culture. He explains, “It describes the importance of character, purpose, responsibility, continuous learning, empathy, and preparation.”

Leveraging this thought, O’Dwyer has championed a unique culture at the heart of Q² Solutions that focuses on employee experience. In fact, this culture has enabled Q² Solutions to continuously grow against adversities and become a leading global clinical trial laboratory services organization.

Headquartered in Durham, NC, Q² Solutions provides comprehensive laboratory testing, project management, supply chain, biospecimen and specimen management, and clinical trial sample and tracking solutions for its clients. The company utilizes next-generation technologies to deliver agile services designed to meet the diverse needs of its clientele around the world and remains committed to its mission of treating each sample as if a life depends on it and assisting clients in turning patients’ hope into the help they need.

Maintaining a Strong Position in Clinical Trial Laboratory Solutions

Q² Solutions’ rich history in the clinical trial space traces back to the parent companies who formed the Joint Venture, Quintiles (now IQVIA) and Quest Diagnostics – two pioneers in the industry. In April 2021, IQVIA acquired full ownership of Q2 Solutions to build on the strong growth prospects of the laboratory industry.

This longstanding experience has enabled Q² Solutions to double its size via lab expansions (in Europe, Asia, and North America) and collaborations with non-profits, including the Coalition for Epidemic Preparedness Innovation (CEPI) in the last three years. Today, as a leading clinical trial laboratory solutions provider, the company has a strong foothold in central laboratory services, genomics, flow cytometry, anatomic pathology, immunoassays, bioanalytical testing, and vaccine testing.

So how does Q² Solutions tackle the unique challenges that its clients face?

The partnering model doesn’t limit its focus to large customers. Q² Solutions ensures that it creates the same connection with the smaller customers.

• Biomarker Discovery: On the biomarker discovery side, sponsors may work with small commercial or academic laboratories that work well on a small scale but are not suited for large clinical trials. To this end, Q² Solutions has built its Translational Science and Innovation Laboratory (TSAIL) to help sponsors earlier in the biomarker discovery process. TSAIL helps them develop translational design strategies to identify, develop assays, and screen multiple biomarkers in parallel, so the most relevant ones can be identified sooner, and proof of concept can be obtained as early as possible.

• Decentralized Clinical Trials: When utilizing a decentralized approach to specimen collection, there are a variety of patient and operations-related factors to consider, including how to supply kits to home nursing companies or rightly process specimens. Q² Solutions has a dedicated decentralized trial team to support study teams from a lab perspective.

In addition, this team works with partners to normalize the use of blood self-collection devices, which could really help reduce patient burden.

• Third-Party Lab Management: Biopharmaceutical company representatives often need to manage upwards of 50 different laboratories. Recognizing this requirement, Q² Solutions manages labs on their behalf, which may entail vendor qualification, quality assessment, scientific review, contracting, quality management, and data management.

• Sample and Consent Tracking: For a successful clinical trial, carefully tracking specimens is critical. BioFortis, a Q² Solutions company, has designed Labmatrix®, a unique software solution that tracks samples throughout their lifecycle across the ecosystem of sites, labs, biorepositories, and other trial partners.

• Trial Complexity: The complexity related to biomarkers, decentralized trials, third-party labs, and sample tracking is compounded by the continuous innovation around lab testing technologies, trial designs like basket and adaptive studies, and the need to minimize the patient burden. This complexity puts pressure on study teams to do more with less. Q² Solutions is dedicated to clinical trial laboratory testing and associated services, providing a one stop shop for all laboratory development needs worldwide. Q² Solutions manages its internal network of laboratories, while coordinating with third-party external laboratories through its laboratory network solutions (LNS) model.

A Disciplined Approach to Client Relationships

Q² Solutions’ biggest differentiator is its ability to help clients unlock the true value of their project or portfolio. The company follows a disciplined approach to client relationships with senior-level oversight around planning, governance, service delivery, and commercial delivery.

Regardless of the size of a customer, Q² Solutions ensures early engagement where they work with a study team long before finalizing a protocol. The company’s dedicated, state-of-the-art Translational Science and Innovation Laboratory (TSAIL) is an excellent example of early engagement from a biomarker discovery and development perspective.

It is designed to provide the agility and breadth of translational science capabilities and expertise required to bridge the gap between preclinical and early clinical drug development and also introduce new biomarker assays into clinical study. This approach ensures that the most effective biomarkers and associated technologies are being validated earlier on and deployed rapidly to accelerate the development of therapeutics.

Q² Solutions’ scientific advisors, who hold extensive knowledge across diverse therapeutic areas, testing modalities, and technical domains, further augment the impact of the partnering model. In addition to consulting with clients in early engagement on protocol design, assay development, and companion diagnostic development, Q² Solutions’ scientific advisors work with customers to create a roadmap of upcoming assay development needs for their portfolio.

From a clinical trial lab testing perspective, this allows them to meet the needs of a customer’s drug development portfolios.

In one instance, Q² Solutions worked with a sponsor in early engagement on a therapeutic influenza study requiring enrollment of influenza-diagnosed patients. Q² Solutions’ scientific and operational advisors addressed this need by reviewing the study protocol and devising the right strategy. An influenza A/B Point of Care Testing (POCT) device was utilized at each investigator site to enable screening and enrollment in a single visit. Also, Q² Solutions’ network of solution providers eliminated the need for the study teams to manage the deployment, training, tracking, and retrieval of the POCT devices.

The Four Pillars of Strategic Plan

Q² Solutions puts great emphasis on receiving customer feedback via customer satisfaction surveys, program and protocol evaluations, and discussions. They also acquire and commission market research and pilot offerings.

For the future, Q² Solutions is pursuing the four pillars of its strategic plan: employer of choice, partner of choice, innovation focus, and quality commitment. To continue being an employer of choice, the company has implemented programs that enhance employee experience, opportunities for development, and allow people to be innovative, brave, and dedicated. Similarly, Q² Solutions plans to enrich the customer experience, champion the investigator and patient experience, and foster internal customer service to emerge as the partner of choice. From an innovation perspective, the company aims to deliver on scientific innovation, digital innovation, and operational innovation. And its quality pillar entails proactive quality management, capitalizing on its process improvement culture, and delivering on sustainability and Environmental, Health & Safety objectives.

Q² Solutions is also expanding its capabilities in oncology, CNS, Infectious Disease, and Companion Diagnostics for scientific innovation and will develop more than 450 new assays this year. From an operational innovation perspective, the company will continue to automate lab processes and expand its delivery models, especially around the biotech segment and decentralized clinical trials. While doing these, Q² Solutions is also focused on acquisitions to strengthen its services. One of them was the acquisition of BioFortis, which provided the company with outstanding sample tracking capabilities. “Over the past few months, we have made a couple of significant acquisitions, namely Rules-Based Medicine (RBM) and Nexelis. These acquisitions will solidify our position as leaders in assay development and testing related to immunoassay biomarkers and vaccines respectively,” concludes O’Dwyer.