Plan, run and report every preclinical study from one connected system.
SIMS brings protocol planning, resource management, facility and animal management, compliance, study conduct, and operational oversight into a connected workflow, from sponsor request to submission-ready reports.
Already have a LIMS? Start with Single Track™ for report automation and SEND →The questions every CRO must answer, and how SIMS answers them
These are not technology questions. They are operational questions that determine how effectively a CRO can plan work, allocate resources, manage execution, maintain compliance, and deliver studies with confidence.
Built for the people who run and interpret preclinical studies
- See capacity across rooms, staff, equipment and animals before committing to a sponsor timeline.
- Track every study on one master calendar.
- Report on facility utilization and activities without spreadsheets.
- Treatment-relatedness flagged at subject and endpoint level, by dose and time.
- Concordance tested with 55 checks and rolled up to reportable endpoints.
- Decisions on adversity and study conclusions stay with the study team.
- SOPs, templates and validation rules held in one Master Data Repository.
- Every entry time-stamped at the source.
- Protocol deviations and SOP compliance reported from the same record.
- See your study while it runs, with as-collected data available contemporaneously.
- Exchange protocols, draft reports and data through the Virtual Data Room.
- Get consistent traceability from collected data, to report, to SEND, for studies (exploratory non-GLP, or GLP) conducted in-house.
From the protocol to decisions, in one connected flow
The protocol is the source of every study activity and every data point. SIMS carries it through the study, so the data the lab collects becomes intelligence the study team can act on.
SIMS goes beyond collecting study data. Single Track™ turns it into decision support for the Study Director
Single Track™ identifies treatment-relatedness at subject and endpoint level by dose and time, tests concordance with 55 checks, and rolls findings up to reportable endpoints.
Automation assists with decision support, but does not replace the Study Director's judgment. Decisions on treatment-relatedness, adversity and study conclusions remain with the study team.
The detail behind the outcomes
SIMS and Single Track™, built on one Master Data Repository
SIMS plans and runs each study and collects its data into one repository. Single Track™ reads that repository to compute signals and draft sub-reports, the study report and SEND. Both work from the same SOPs, templates, rules and checks. Select any block to see what it does.
Beyond data capture: integration, monitoring and reporting
Xbiom SIMS handles instrument interfaces on the LAN, study data storage, study set-up, bio-statistics and subject tabulations, and extends into the capabilities often left to spreadsheets, sub-contractors and manual effort.
- GLP: 21 CFR Part 58 and OECD
- 21 CFR Part 11 audit trails and e-signatures
- SOC 2 certified infrastructure
- IQ / OQ / PQ validation packages
- Role-based access control
- Open APIs: OData, SQL, R, Python
What the study team gets after adopting SIMS
Operational and study analytics from one record
Because planning, study conduct and study data sit in one system, SIMS reports on both the operation and the science without exports or spreadsheets. Thresholds and rules come from the Master Data Repository, so every study is measured the same way.
Reduce time to study report by 3–4 weeks
SIMS supports the study operational layer. Single Track™ extends the connected study record into scientific review, reporting and SEND. Because SIMS already holds the complete, integrated study record, Single Track™ can analyze it and draft the report without a separate data integration step. Conventionally, the study report follows 4–6 weeks after histopathology and sub-reports, and a SEND team adds another 4–5 weeks. Single Track™ automates analysis and report drafting, and generates SEND from the same record when needed.
From where you are today to running on SIMS in 4–6 months
Implementation starts from your existing SOPs, facilities and instruments. The PointCross team converts them into SIMS master data, connects your lab, and runs a pilot study with your team before go-live.
See SIMS in action
Walk through a digital protocol, study calendar and master calendar with the PointCross team, and see Single Track™ draft report sections from the same record.
