Deliver Study Reports 2 weeks faster
Draft report sections from your data, your templates, and protocols, controlled by your Study Director in one or more languages. Review, QC and publish SEND alongside the Study Report. No more waiting 4 to 5 weeks.
Single Track™ runs on data from your existing LIMS or spreadsheets. When you are ready to run the study itself from one record, see Xbiom SIMS.
See Xbiom SIMS →Study Report & SEND timelines take 8+ weeks at traditional CROs
Weeks of Manual Work
Study directors spend hours manually transcribing data from LIMS, histopathology systems, and bioanalytical platforms into Word templates — a time-intensive, error-prone process.
Duplicated Effort, Compounded Delays
SEND teams wait for Study Report completion, then separately wrangle the same source data to create SEND datasets. This duplicated effort adds 5–6 weeks of unnecessary lag time and introduces reconciliation risks.
Quality & Compliance Risk
Manual transcription and dual data entry create discrepancies. Late-stage corrections cascade through both deliverables, triggering costly rework cycles and jeopardizing submission timelines for Sponsors.
Study Reports delivered 2 weeks faster, with SEND ready at report generation
One source of truth drives both deliverables in parallel, controlled end to end by your Study Director.
Integrate As-Collected Data Sources
Connect directly to your as-collected source systems, no manual transcription required.
GenAI-Augmented Report Generation
Shaped in the Study Director's style and report structure, freeing them to focus on interpretation, pharmacological and biologic reasoning, and assessment of computed signals.
SEND Ready at Report Generation
Version-controlled Study Report and SEND datasets allow review while final, submission-ready SEND packages are generated only after data lock and final report approval.
Review & Submit
Study Directors approve narrative text and auto-flagged QC findings, including a master list of protocol deviations; SEND passes validation with XBIOM and eDataValidator.
AI-Generated Narratives with Study Director Review
XBIOM™ generates report sections from Study Director and study templates, actual study-conduct data and records, and where needed, comparison with the protocol and CoA from the Sponsor. Coherent, compliant narratives that follow regulatory standards and your templates.
SEND Generation at Report Finalization
Study reports and SEND datasets are generated simultaneously from the same source data, ensuring perfect alignment and minimizing time for reconciliation.
Full Traceability
Every data point traces back to as-collected source data with complete audit trails. Changes propagate automatically with version management to keep the Study Report and SEND consistent.
Smart Quality Checks
Built-in validation checks deliver regulatory-submission-compliant SEND datasets, with findings flagged automatically for Study Director review.
Automate study data collection, analysis and reporting, from protocol to SEND
The digital protocol, its schedule of activities and the as-collected data move through one harmonized record into concordance analysis, signal detection, report authoring and SEND.
Hover over or select any step. Start with SIMS at step 01, or bring your existing LIMS data straight into Single Track™.
One data stream from collection to submission: the as-collected data, the study report and the SEND datasets stay traceable to one another, as FDA’s Technical Conformance Guide v6.2 (June 2026) expects.
Explore Xbiom SIMS →Transform your CRO's efficiency and competitiveness
Faster Study Report Delivery
Complete study reports that previously took weeks are now ready 2 weeks faster. Win more competitive bids with accelerated timelines.
Cost Savings per SEND Dataset
Re-capture cost savings on average for each SEND dataset to improve study margins.
Consistency & Traceability, Built In
A shared source of truth from as-collected data ensures perfect alignment between study reports and SEND datasets. No manual reconciliation delays.
Weeks to SEND
A 5–6 week faster study deliverable package, with SEND available at the time of study report generation.
Part of Xbiom SIMS
Plan, run and report every study from one record.
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