From raw source data to submission-ready standards
PointCross standardizes data from clinical, biomarker, nonclinical, preclinical and other ancillary assays. Our team builds the tools, workflows and intelligent automation that curate raw source data into de facto standards, and convert them to de jure standards such as SDTM, ADaM and SEND, conformant to CDISC, FDA and PMDA rules.
Standardization services for every data type
Four focused services, one standardization team. Pick the service that matches your data, or combine them across a program.
SEND Generation
Nonclinical and preclinical study data converted into SEND datasets, conformant to the rules established by CDISC, FDA and PMDA.
- Raw study data & CRO extracts
- SEND & Controlled Terminologies
- Submission-ready datasets
Automated SDTM Generation from EDC
Clinical trial data from your EDC systems curated and converted into SDTM domains using automated tools and workflows.
- EDC extracts & ODM
- SDTM & Controlled Terminologies
- Automated, repeatable conversion
ADaM for Clinical
Analysis-ready ADaM datasets derived from standardized trial data, servicing direct analysis and the generation of derived metadata.
- SDTM-based derivations
- ADaM & Controlled Terminologies
- Analysis-ready, traceable datasets
Biomarker Assays
Biomarker, bio-analytics and specialty assay data curated into standard models alongside your core study and trial data.
- Assay stores & specialty labs
- ODM & Universal Data Models
- Integrated with study data
Tools, workflows and automation, not manual curation
Our Data Standardization team develops the tools, workflows, intelligent machine and automation systems that turn raw source data into standards your analysts and reviewers can rely on.
Curation into de facto standards
Raw source data is curated into de facto standards such as ODMs or Universal Data Models that can service direct analysis or the generation of derived metadata.
Automated conversion to de jure standards
Automated tools convert data from de facto standards to de jure standards such as SDTM, ADaM, SEND and other standards published by CDISC or the agencies.
Every data type, one pipeline
Clinical, biomarker, nonclinical, preclinical and other ancillary assay data move through the same tools and workflows, so standardization is consistent across a program.
CDISC, FDA and PMDA rules
Converted datasets are conformant to the rules established by CDISC, FDA and PMDA, so what leaves the pipeline is ready for analysis, review and submission.
From raw source to conformant datasets
One pipeline takes your data from raw extracts to standards-conformant, submission-ready datasets.
Curate to de facto
Tools, workflows and intelligent automation curate raw source data from clinical, biomarker, nonclinical, preclinical and ancillary assays into ODMs or Universal Data Models.
Analyze or derive
The de facto models service direct analysis or the generation of derived metadata, without waiting for the final submission datasets.
Convert to de jure
Automated tools convert the data to SDTM, ADaM, SEND or other published standards, conformant to the rules established by CDISC, FDA and PMDA.
Fluent in the standards your reviewers expect
From de facto models that keep data moving, to de jure standards published by CDISC and the agencies, every conversion is checked against the conformance rules established by CDISC, FDA and PMDA.
Data standardization, answered
What are Data Standardization Services?+
What are de facto and de jure standards?+
Are the converted datasets conformant?+
Which data types are covered?+
Raw data in, conformant standards out
Talk to us about standardizing your clinical, biomarker, nonclinical and ancillary assay data, or go straight to the service that fits your study.
