Monitor & Analyze Ongoing Nonclinical Studies on Xbiom™ For CROs

Sponsors are increasingly requiring interim study analysis. This presents an opportunity for CRO partners to generate interim datasets for their Sponsor customers that are analysis-ready and made available to both the CRO Study Director and Sponsor on a secure, web-enabled and user-friendly platform that enables data visualization and generation of Tables, Listings & Figures.

How?

Our solution for interim monitoring involves ingesting raw, as-collected data from disparate sources including LIMS and a variety of immuno-marker, OMICs, and other datatypes. This data is ingested, curated, and made available on the Xbiom™ platform – and CROs can offer this capability immediately to their sponsor clients without any changes to their existing SOPs or processes, and without any additional infrastructure or investments. We offer this capability at a fixed price per study should your Sponsor want interim analysis on a specific upcoming study, or as a subscription for CROs managing multiple studies and Sponsors (thus needing numerous secure instances).

  • Sponsors access the data provided by CROs on a secure, encrypted space that is shared with authorized Sponsor users, for interim data analysis and visualization of the progress
  • CROs are given their private, secured cloud environment through which raw data can be uploaded for automatic curation by PointCross’ Smart Transformation module.
  • CROs get access to all the studies they designate for this monitoring service and they can use this private space to load interim data from their LIMS.
  • Generate quality and consistent SEND datasets along with the required Define.xml and nSDRG upon study completion or at any time thereafter
  • A 100% data consistency and reconciliation is performed against the Study Report on all studies for which PointCross enables interim study monitoring, helping meet the TCG and avoid the TRCs that the FDA Applies.
  • PointCross SEND data standardization includes a 100% data consistency and reconciliation, which is performed against the Study Report on all studies for which PointCross enables interim study monitoring, helping meet the TCG and avoid the TRCs that the FDA Applies.

Our CRO customers trust PointCross to directly generate their SEND datasets on behalf of their Sponsor clients. Because LIMS adaptors have not proven to effectively automate the generation of Trial Designs (and we see this reflected in both ongoing and completed trial data), Sponsors refer to our SEND-ASSURE service for 100% quality and consistency check against the Study Report.