Orchestrating study data for the modern biopharma industry
Run preclinical studies in Xbiom SIMS, deliver the study report and SEND together with Single Track™, and submit validated SEND datasets with full traceability from source to submission.
Answer a few questions about your study and see your SEND price right away.Run the study, report it, submit it. Start wherever you are today.
Each offering works on its own. Together they share one Master Data Repository and one record of the study, so the as-collected data, the study report and the SEND datasets stay traceable to one another.
Preclinical study management, from digital protocol to signed report
Plan, schedule, collect and monitor every study from one record. Digital protocols, master calendars, lab instrument integration and as-collected data with chain of custody.
- For CRO operations, Study Directors, toxicologists and QA
- Sponsors see their study while it runs
- Implementation in 4–6 months
Study Reports and SEND in 2–3 weeks. Not ten.
Compliant Study Reports and SEND datasets generated from one data source, delivered together after data lock and controlled by your Study Director.
- Runs on your existing LIMS or spreadsheet data
- 30–50% cost savings
- SEND ready at report generation
From study data to submission-ready SEND
Xbiom™ transforms as-collected, disparate, raw data sources into validated SEND datasets, Define.xml and nSDRG, with full traceability from source to submission.
Get an instant SEND quote →Solutions for every stage of drug development
From discovery to post-market, PointCross has the products, solutions and services that fit each step of the journey.
Nonclinical CROs
Run studies in Xbiom SIMS, deliver study reports and SEND together with Single Track™, and win bids on turnaround.
Pharma and biotech sponsors
See your study while it runs, get validated SEND for every IND, and keep traceability from collected data to report to SEND.
Clinical and translational teams
Clinical data orchestration for analysis-ready datasets, with interim monitoring and metadata management.
Regulatory and submission teams
Package SEND, SDTM, ADaM and TFLs for submission, validated against CDISC, FDA and PMDA rules before anything is sent.
One in four FDA SEND submissions runs through Xbiom™
The same validated engine produces SEND for our services team, for Single Track™ and for studies run in Xbiom SIMS, with eDataValidator checks against CDISC standards before anything is submitted.
Watch: Study Report and SEND generated within 30 minutes →Latest from PointCross
The clinical data automation platform behind every product
Xbiom is RAG-enabled with secure LLMs deployed inside your firewall, so study data and insights can be queried in plain English without exposing proprietary trial information to external services.
Ready to learn more?
Schedule a call to explore how Xbiom SIMS, Single Track™ and our SEND services fit your studies.
