In nonclinical studies, waiting until the completion of a study to make data-driven decisions may limit the potential for valuable insights. Traditional study reports published post-completion often lack the ability to provide on-study analysis and early indicators crucial for driving amendments and gaining deeper insights. Here comes Xbiom™ Insights, a cutting-edge interim nonclinical study monitoring solution that revolutionizes the way we approach data integration and analytics.
Real-Time Decision-Making:
The challenge lies in adapting protocols, considering alternative trial designs, and identifying toxicity signals early in the study process. Xbiom™ Insights addresses these issues by offering real-time integration of disparate Laboratory Information Management System (LIMS) and assay data from various sources, providing near-instantaneous access to sponsors and toxicologists.
Agile Aggregation with Xbiom™:
Xbiom™ Insights operates on an agile aggregation model, allowing longitudinal integration of data as often as twice-daily, and from sources including handwritten observations, instrument collected reports. This flexibility empowers Study Monitors to make informed decisions during the course of the study, fostering a proactive approach to protocol adjustments and trial design modifications.
Data Concierge Service:
Facilitating this seamless integration is PointCross’s Data Concierge service —a virtual team comprising data management, data science, statisticians, and data scientists. This collaborative effort ensures that data from diverse sources and Contract Research Organizations (CROs) is effectively coordinated and integrated in near-real-time.
Comprehensive Monitoring with Data-as-a-Service:
The platform’s Data Concierge service collects and loads a variety of data types, including cytokines, bioanalytic, OMICs, ADA, FACS, IHC, and more. This comprehensive approach allows toxicologists, safety researchers, nonclinical study monitors, and informatics stakeholders to analyze data in any way they desire, enhancing the monitoring experience.
Reducing Surprises, Minimizing Gaps:
Interim monitoring with Xbiom™ Insights ensures periodic analysis and visualization, leading to fewer surprises and minimal data gaps when preparing the final dataset. Consistency checks against the interim set provide confidence in the final dataset’s accuracy, promoting robust submissions.
Cost-Efficient SEND Datasets:
As the submission phase approaches, Xbiom™ Insights streamlines the process by generating Standard for Exchange of Nonclinical Data (SEND) datasets with nSDRG and Define.xml at 50% of the indicated SEND cost, further emphasizing its cost-efficient and time-saving benefits.
Secure and Accessible:
Xbiom™ Insights is offered through a subscription model or on a per-study basis, delivered securely on a private, encrypted, cloud-based environment. This ensures authorized and user-defined access, allowing stakeholders to harness the power of real-time data without compromising security.
Conclusion:
Xbiom™ Insights emerges as a game-changer in the world of nonclinical study monitoring, empowering stakeholders to make informed decisions in real-time. With its secure, agile, and comprehensive approach, this platform represents a significant leap forward in bridging the gap between interim monitoring and final submissions. Embrace the future of nonclinical study monitoring with Xbiom™ Insights—where real-time insights pave the way for smarter, more adaptive research.