Interim Nonclinical Study Monitoring

Study Reports published after the study is completed offer little, if any, opportunity to make data driven decisions that can be made while the study was ongoing. Interim reports providing on-study analysis often times do not allow for early indicators that may drive more on-study amendments and insight. Adapting protocols, considering alternate or new trial designs on other studies being planned, or advantages of identifying toxicity signals early in anticipation of the final conclusions of the Study Director can be achieved with monitoring of interim data on ongoing studies, and study data can be loaded as often as twice-daily or even weekly. The Study Monitor is empowered to decide. For PointCross, this requires agile aggregation and longitudinal integration of disparate LIMS and Assay data from multiple sources, and making this available to the sponsor toxicologists in near-real-time.

That platform is Xbiom™, available as a subscription or on a per-study basis, and delivered on a private, encrypted, cloud-based environment to enable secure, authorized and user-defined access. The longitudinal integration and coordination with data sources and CROs is done by our Data Concierge service staffed by a virtual team of data management, data science, statisticians, and data scientists working with the sponsor’s toxicologist. For small BioTechs, we also offer board certified toxicologists for consults.

During monitoring, the data-as-a-Service, or Data Concierge, collected and loads cytokines, bioanalytic, OMICs, ADA, FACS, IHC or other data and integrates it on Xbiom™ so Toxicologists, Safety Researchers, Nonclinical Study Monitors, and informatics stakeholders can analyze the data in any way they wish, with any grouping or cohorts, on a powerful and intuitive data platform. Interim monitoring accommodates all in-vivo studies including Transgenic, Xenograft, or Animal Rule models.

Periodic analysis and visualization while monitoring your study also means fewer surprises and minimal data gaps when the final dataset is prepared. 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 at 50% of the indicative SEND cost.