Data-driven decisions on ongoing nonclinical studies
Monitor interim data on your in-life studies in near real time on Xbiom™. We aggregate and longitudinally integrate disparate LIMS and assay data from multiple sources, so your toxicologists can act while the study is still running, not months after it closes.
The Study Monitor is empowered to decide
Study reports published after the study is completed offer little opportunity to make data-driven decisions that could have been made while the study was ongoing. Interim monitoring changes that, surfacing early indicators that drive on-study amendments and insight.
Adapt protocols while the study runs
Periodic analysis lets you amend on-study, consider alternate or new trial designs for studies still being planned, and act on early signals instead of waiting for the final report.
Catch toxicity signals early
Identify toxicity signals early, in anticipation of the Study Director’s final conclusions, so decisions are informed rather than reactive.
Fewer surprises at final dataset
Periodic analysis and visualization while monitoring means fewer surprises and minimal data gaps when the final dataset is prepared, and a cleaner path to lock.
Load cadence you control
Study data can be loaded as often as twice-daily or weekly. The choice of cadence, grouping, and cohorts stays with you.
Any data type, analyzed any way you wish
During monitoring, our Data Concierge collects and loads your data onto Xbiom™, where Toxicologists, Safety Researchers, Nonclinical Study Monitors, and informatics stakeholders can analyze it with any grouping or cohorts on a powerful, intuitive platform.
Built for every in-vivo study
Interim monitoring accommodates all in-vivo studies, with longitudinal integration handled by our team across model types.
From disparate sources to a decision
Longitudinal integration and coordination with data sources and CROs is run by our Data Concierge, a virtual team working alongside your toxicologist.
Collect & load
The Data Concierge collects and loads cytokines, bioanalytic, OMICs, ADA, FACS, IHC and other data, as often as twice-daily.
Integrate
Disparate LIMS and assay data from multiple sources is aggregated and longitudinally integrated on Xbiom™.
Analyze
Toxicologists and study monitors explore the data with any grouping or cohorts, visualizing trends in near real time.
Decide
Early indicators drive on-study amendments, alternate trial designs, and earlier toxicity calls.
Delivered on Xbiom™ with a Data Concierge
Xbiom™ is available as a subscription or on a per-study basis, delivered on a private, encrypted, cloud-based environment for secure, authorized, user-defined access. Our Data Concierge, a virtual team of data management, data science, and statisticians, works with your toxicologist. For small BioTechs, we also offer board-certified toxicologists for consults.
One integrated dataset, all the way to SEND
Final datasets with individual subject data and Trial Design domains can be cross-checked against the interim set, assuring data consistency. When the submission is planned, SEND datasets with nSDRG and Define.xml can be generated from this integrated data.
Interim monitoring on Xbiom™, answered
What is interim nonclinical study monitoring?+
How often can study data be loaded?+
What data types can be monitored?+
Which study models does it support?+
What is the Data Concierge service?+
How does monitoring connect to SEND?+
Decide while your study is still running
Put your disparate LIMS and assay data on one platform in near real time, surface early signals, and carry the same integrated data through to SEND. Start interim monitoring on Xbiom™.
