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Translational and clinical teams spend more than 70% of their time managing, cleaning, and harmonizing data generated in biomarker-rich clinical programs. In a recent webinar, Adam Brown demonstrated how the QuartzBio® enterprise Biomarker Data Management (eBDM) solution addresses one set of frequently intractable challenges: connecting raw, processed, and ancillary data across multiple clinical studies. Read more →

Keeping track of clinical trial samples across multiple sites and vendors can be manual and tedious (recent post) -- we have demonstrated how virtual Sample Inventory Management can streamline the day-to-day reporting of sample collections, shipments, and discrepancies (webinar series). Read more →

The challenge: Maintaining clinical trial timelines dependent on vendor performance A global biotechnology company with seven clinical-phase programs approached QuartzBio with a challenge shared by many organizations in the industry -- overall assessment of clinical trial vendors and sites was time-consuming and unreliable, given global site footprints, complex sample lifecycles, and inconsistent naming across sites and vendors. Tasked with preparing regular executive summaries, the company’s clinical and biomarker operations teams were spending significant time deriving trial-wide key performance indicators (KPIs), lacking visibility into vendor performance – and challenged to translate current experience into future study planning. This lack of visibility Read more →

The challenge: Maintaining clinical trial timelines dependent on vendor performance A global biotechnology company with seven clinical-phase programs approached QuartzBio with a challenge shared by many organizations in the industry -- overall assessment of clinical trial vendors and sites was time-consuming and unreliable, given global site footprints, complex sample lifecycles, and inconsistent naming across sites and vendors. Tasked with preparing regular executive summaries, the company’s clinical and biomarker operations teams were spending significant time deriving trial-wide key performance indicators (KPIs), lacking visibility into vendor performance – and challenged to translate current experience into future study planning. This lack of visibility Read more →

Video: Centralized, harmonized data overcomes silos, revealing insights. Overcome data silos QuartzBio’s enterprise Biomarker Data Management solution links assay and clinical data across file types from any assay technology--transcriptomics, genomics, proteomics, flow cytometry, imaging, and more​. Users across multiple teams can explore, collaborate on, and report their data using our suite of analytics and reporting solutions.​ ​Here’s how different teams are using the solution:​ Biomarker Operations: Systematically verify data quality, consistency, and availability with automated checks​​ Translational Researchers: Explore and visualize biomarker trends across cohorts, subjects, and timepoints and perform exploratory analyses to surface signals of interest Bioinformatics Teams: Generate Read more →

Video: The journey of clinical samples and their derivatives is complex. Sample intelligence made easy. Clinical samples traverse a complex path, with data located in multiple systems, which may not be "sponsor-centric." Sponsor teams have implemented the QuartzBio® virtual Sample Inventory Management (vSIM) solution to gain visibility. Here’s how different teams are using the solution: Biospecimen / Biomarker Operations: Tracking samples and consent status across the biospecimen lifecycle​, making sure that the right samples and data arrive at the right place, on time. Clinical Operations: Addressing discrepancies before database lock, monitoring site and vendor performance and retraining sites if needed Read more →

February 9, 2022 — Clinical operations leaders use the QuartzBio® virtual Sample Inventory Management (vSIM) solution to maintain robust visibility across sample collection and processing status, consent status, and sample and derivative quality information. Traditionally, generating these reports is frustratingly time-consuming – often involving spreadsheets that attempt to manually link key information from the EDC, central labs, testing labs, and biorepositories to illuminate critical information like discrepancies or missed collections. The QuartzBio team has identified six critical on-study reports that our clients prioritize as absolutely required for effective sample and biomarker operations. Read more →

January 10, 2022 — With immuno-oncology assets progressing in the clinic, a growing biotechnology company we work with faces an increasingly common challenge: Their trials are generating large datasets across a wide range of assay modalities (Figure 1), but the data remains siloed. In addition to clinical data coming from the clinical research organization (CRO), the velocity of data coming from an assay services laboratory continuously delivering biomarker data from flow cytometry, immunohistochemistry, and genomics platforms quickly becomes overwhelming. Still another, separate data stream comes from a specialty laboratory delivering T-cell receptor (TCR) profiling data. Read more →

November 19, 2021 — As we discussed in our recent webinar, QuartzBio’s virtual Sample Inventory Management (vSIM) solution empowers clinical operations and translational research teams by integrating multiple sources of sample information, both within and across studies. The platform enables users to interact with harmonized data from multiple sources, gain critical insights via KPI and data issue reporting, and manage queries resulting from those data inconsistencies. Read more →

October 8, 2021 — Sponsors are challenged to keep track of complex sample inventories, both on study and for samples collected as part of completed studies that might be later mined for translational research needs. We frequently hear that teams spend significant time manually cross-referencing spreadsheets of inventory data, to answer questions such as: “How many whole blood samples with a particular mutation do we have across all phase I studies?”“Can we report sample expiration status across all of our contracted biorepositories?”“When we identify a sample of interest, how can we confirm consent status?” Read more →