Oncology Clinical Development ubiquitously uses biomarkers in clinical trials for a range of intended uses. These biomarkers span a range of technologies, require different levels of validation, and ultimately, biomarker data supports submission and approval for the therapeutic. Q² Solutions, with its vast array of validated assays, is able to support most of these requirements across its global testing laboratory network. Of particular relevance for oncology, Q² Solutions provides quick turnaround biomarker data to support patient selection for clinical trials and enable targeted investigational therapeutics to be provided to patients. Underpinned by our wide-ranging oncology clinical trial lab expertise, proven methodologies and cutting-edge technologies, Q² Solutions can effectively support end-to-end oncology-specific testing and assessment needs across Phase I, II and III studies through our global lab network, including:

• Providing key laboratory data for solid tumor, leukemia, lymphoma and multiple myeloma studies worldwide
• Gaining insights on pharmacokinetics/pharmacodynamics, proof of mechanism safety and efficacy and target patient selection
• Supporting large and small molecule, vaccine, cell and gene therapy and biosimilar programs
• Enabling precision medicine through Companion Diagnostics development and related assay validation via CAP and CLIA to ensure use in clinical decision making
• Providing services for investigational use only studies to work toward in vitro diagnostic registration through seamless and long-standing partnerships with leading IVD companies

Q² Solutions provides assay validation services per intended use and is equipped with a comprehensive assortment of assays that are already validated and ready for clinical trial testing. The principal technologies served are IHC and FISH, genomics, flow cytometry, and circulating protein biomarkers.

At Q² Solutions, we understand that gastro-intestinal and hepato-biliary disorders often require multi-disciplinary approaches to help successfully navigate related clinical trial lab testing and pathology. Our expert pathologists with both GI and liver subspecialty knowledge and extensive clinical care practice can help guide clinical lab testing strategies and anatomic pathology evaluation across key focuses in these disease areas:

• Inflammatory bowel diseases (ulcerative colitis, Crohn’s)
• Infectious (viral) hepatitis
• Non-alcoholic fatty liver disease
• Non-alcoholic steato-hepatitis
• Neoplastic diseases (hepatocellular and colorectal carcinomas and cholangiocarcinoma)
• Safety testing for hepato-toxicity
• Immuno-oncology testing for GI and liver-specific neoplastic diseases

Leveraging artificial intelligence-driven enhanced image analysis and next-generation technologies, our expert pathologists can dive deeper into complicated histologic disease patterns and extract meaningful data to help understand disease stage and responses to treatment.

Supporting a range of CNS indications, our expert team provides global lab testing and assessment capabilities across Phase 1, 2 and 3 studies to support disease identification, inflammation and other intended use needs. Highly specialized in Alzheimer’s disease, the global network allows our team to offer a broad scope of services through the full clinical development program, including:

• Discovery and translational science assay development to support novel assays across blood, serum/plasma and cerebrospinal fluid matrices.
• Globally harmonized testing, including options in China, through instrumentation such as Quanterix, Simoa, MSD, Luminex, Lumipulse and more.

Learn more about Alzheimer’s Disease Clinical Trials here

As public health needs evolve rapidly, our global lab network of microbiologists highly experienced in infectious disease and vaccine-specific clinical lab testing are equipped to uphold quality standards in practices with agility and scalability. Q² Solutions has extensive services in:

• Bacterial testing from culture and antimicrobial testing to leveraging ELISA technology to detect bacterial antigens and automated processes for bacterial identification, susceptibility and gram staining.
• Viral testing, specializing in HIV, hepatitis, COVID-19, RSV, influenza and more, we house  many testing modalities, allowing identification via screening assays, resistance testing, sequencing and flow cytometry for immunophenotyping.

Quality is a top priority as we keep to standards and guidelines issued by the Clinical and Laboratory Standards Institute and the College of American Pathologists with oversight from experienced scientists and reliance on best-in-class tech-enabled solutions. 

From rheumatoid arthritis to multiple sclerosis to systemic lupus erythematosus, Q² Solutions has vast experience in providing clinical trial lab testing to support a range of immunology conditions. With patient safety and efficacy evaluations key, the expert team supports lab assessments from Phase 1 to Phase 3 studies. Our scope of services, include:

• Discovery and translational science assay development services to support assays and testing technologies used downstream.
• Cell-mediated immunity testing through flow cytometry, EliSpot assays, peripheral blood mononuclear cell isolation, etc.
• Humoral immunity assays (i.e., immunoglobulins; complement pathway and a variety of cytokine, chemokine and proinflammatory panels). 

Q² Solutions is equipped with deep therapeutic expertise and transformative solutions to support all phases of clinical development specific to endocrinology. The broad scope of clinical trial lab testing services offered, includes:

• A full suite of testing options for assay validation and clinical trials lab testing across, bioanalytical and protein sciences, delivering critical biomarker assessments.
• Therapeutic indications include testing for obesity, women’s reproductive health, male infertility, hypothalamus-pituitary-adrenal pathways, thyroid gland indications and large global diabetes programs.
• Lab assessments for endocrinology Phase 1 through 3 studies for uses such as pharmacokinetics/pharmacodynamics and proof of mechanism safety and efficacy.

The expert team can also provide Discovery and Translational Science assay development services to support the new assays and technologies that maybe used downstream.