Data Standardization Services

PointCross offers data standardization services for clinical, biomarker, nonclinical, preclinical assays and other ancillary assays conducted. Raw source data, regardless of file type, is curated and harmonized into de facto standards such as ODMs or Universal Data Models that service direct analysis or generation of derived metadata.

 

Our suite of tools, workflows, and intelligent machine and automation systems routinely convert data from de facto standards to de-jure standards, such as STDM, ADaM, SEND, or other published standards by CDISC or other agencies.

 

PointCross serves Sponsors, CROs, Federal Agencies, and consulting organizations for both preclinical and clinical stage data requirements.

 

For preclinical SEND requirements, PointCross is a leading SEND provider responsible for having generated and quality checking over 25% of all SEND submissions to the FDA since the introduction of the SEND mandate. PointCross generates SEND data packages that are 100% traceable and consistent with the final Study Report, at industry’s lowest price guaranteed.

 

Click the below link to generate a no-obligation, instant SEND quote.

 

Automatic Quote Generator

For Clinical and Translational R&D and submission, PointCross longitudinally integrates EDC and biomarker data for the automatic generation and analysis of SDTM and ADaM sets. Clinical trial stage Sponsors and CROs that want to monitor ongoing studies for translational research often want to track biomarkers from specialty assays that are aligned with CRF data in the EDC.

PointCross’ approach is to curate, impute, and longitudinally integrate the EDC data with the biomarker data (e.g. immune-assays for cytokines, ADA, etc.), and this is done with automation and data mapping tools that scrape EDC and biomarker data within (1) business day.

The added advantages offered by having harmonized, integrated clinical data in a universal data model include:

  • search for and selection of stratified cohorts is in real time without the need to generate ADaM for each analysis cycle
  • perform analysis of any of the selected patient / subject cohorts, and rapidly generate TFLs that are searchable and publishable – including for pre-templated TFLs that auto-update with each new data load
  • Generate SDTM at-will, any number of times, from the integrated data model (UDM)

Use the SAP to generate the ADaM sets (ADSL, BDS and OCCDS) from the UDM at-will, in real time, allowing running scripts used for running the SAPPointCross supports biometrics and Clinical Operations teams who have faced challenges in reconciling and correcting EDC data with missing or incorrect timepoints and other data gaps – each of which are identified during the EDC scrape and shared with the customer.

 

Biometrics teams that are accustomed to generating SDTM in 4-6 weeks are now able to instantly run analytics – even for the same cohort criteria as in the SAP, within a matter of hours, thus providing an early view into what the biostats teams generate after the ADaM sets are available.

 

Email us at get_started@pointcross.com for a demonstration walk-through, or use the contact box on the right side of this page.