Taking a candidate drug to market – and to the patients who will benefit from it – requires supporting data from high-volume, regulated clinical studies. From sample receipt to final reporting, Q2 Solutions understands the importance of delivering qualified clinical sample data throughout all stages of the drug development cycle.
Q2 Solutions’ bioanalytical experts can partner with you to develop biomarker assays and cell-based bioanalytical assays that incorporate state-of-the-art instrumentation, rigorous quality control, and a logistics infrastructure to support large-scale, international studies.
Q2 Solutions can support your large-scale clinical projects by leveraging:
- Expertise in developing assays for human samples
Q2 Solutions has earned a reputation for excellence in method development through our experience with assaying human samples. Transitioning from animal studies to human subjects requires assays that can measure novel metabolites and accommodate low-level dosing studies. Q2 Solutions will work with you to develop automated small molecule LC/MS assays, large molecule ligand binding assays, and large-molecule hybrid-LC/MS assays including high resolution mass spectrometry, to support all phases of the clinical trial process.
- An end-to-end assay development process
Recognizing that a clinical assay must be reliable over a period of years, Q2 Solutions has implemented a rigorous procedure to ensure quality and reduce risk. Prior to validation, each assay undergoes a formal pre-qualification process in which Q2 Solutions scientists review preliminary data and assess modifications necessary to support validation.
- Project managers with scientific expertise
All Q2 Solutions Project Managers are scientists with hands-on experience in analytical methodologies. Our Managers understand the science behind the assays, verifying data quality and assuring that assays run smoothly for the duration of the project. Through weekly or bi-weekly updates, our Project Managers will address concerns or questions as they arise and serve as active collaborators in decision-making.
- A Global Presence to Support International Studies. Q2 Solutions combines local expertise with a global logistics network to support sample processing for international clinical studies. With facilities in the United States and China, Q2 Solutions complies with global bioanalytical regulatory guidance. Q2 Solutions is certified by ANVISA, the Brazilian health regulatory agency.
- Flexibility with Transparency. All assays carried out at Q2 Solutions facilities adhere to a common set of SOPs, thereby assuring consistent data quality. Bioanalytical and clinical Project Managers from different internal teams communicate regularly to resolve sample processing issues in a timely and transparent manner. Q2 Solutions bioanalytical laboratories integrate with central facilities, offering a flexibility to adapt to shifting analytical demands and customer timelines.
