Toxicologists, safety researchers, nonclinical study monitors, and informatics stakeholders are representative of our Sponsor customer profile. They focus on monitoring, analysis, and visualization of interim and completed datasets that PointCross has loaded from CROs and ingested on Xbiom™.
Disparate data, including immuno-markers, cytokines, bioanalytics, OMICs, ADA, FACS, IHC, etc.) are loaded by CROs and specialty labs into a private, encrypted space dedicated to the Sponsor. This data is available for the Sponsor to analyze the data in any way they wish, with any grouping or cohorts, on a powerful and intuitive data platform.
- Sponsors monitor interim studies while integrating all adjunct components of the study: PointCross integrates with the CRO and ingests raw, as-collected data and LIMS extracts for in-life specialty assays, and other bio-analytics
- All interim datasets generated are then reconciled with the final Study Report should the Sponsor choose to submit the data in SEND
- Gaps in data or issues in Trial Design domains are automatically captured and notified, so the Sponsor is certain of the submission-readiness of the SEND dataset
Analyzable Data is Submittable Data:
- Sponsor may also load completed studies and other preclinical studies for their private analysis and visualization
- Complex and new datatypes, including ADA and immuno-markers are easily accommodated in Xbiom™ and able to be analyzed in a longitudinal fashion. Xbiom™ routinely ingests preclinical data from various study models from In-Vivo animal studies including Transgenic and Xenograft models.
Sponsors trust PointCross to directly generate their SEND datasets once the Study Report has been finalized.
- SEND datasets are even faster and cheaper to generate when the data is collected and standardized during interim monitoring, because issues in Trial Design domains and data gaps are identified early on, leading to less “reconciliation” time while your CRO generates the Study Report
- PointCross routinely generates submittable packages of SEND datasets, nSDRG, and Define.xml to meet the Technical Conformance Guide (TCG) and avoid the Technical Rejection Criteria (TCR) that the FDA apply.
- For Sponsors with completed SEND datasets, these are able to be loaded into Xbiom for analysis, 100% consistency and quality assurance (SEND-ASSURE), and can be used for cross-study analysis against other completed or current studies.