Digitize, analyze and warehouse your legacy clinical trials
Studies completed before the SDTM mandate live in PDFs. PointCross digitizes them into fully query-able, analysis-ready datasets, warehoused in Xbiom™ or your own repository, in as little as 3 to 5 weeks.
Five outcomes from every digitized study
PointCross has supported several sponsors rethinking their clinical data warehousing strategy. Every digitized study delivers five outcomes, regardless of how old the data is or which SDTM-IG version it needs to target.
Fully query-able datasets
Every digitized legacy study becomes a fully query-able dataset. Scientific queries, audit requests and regulatory agency questions are answered directly from data, not PDFs.
- Structured, indexed patient data
- Audit and regulatory queries
- No more PDF hunting
Stratified cohort & cross-parameter analysis
Repurposing and exploratory analysis become straightforward. Stratified cohort analysis, cross-parameter analysis and integrated patient profiles are readily achieved.
- Exploratory & repurposing analysis
- Stratified cohort analysis
- Cross-parameter analysis
Findings at your fingertips
Outputs are warehoused on a secured instance of the Xbiom™ analysis workbench or delivered to a target model outlet suitable for the sponsor's internal repository.
- Xbiom™ or sponsor repository
- Secured, accessible instance
- Visualization built in
Harmonized for any SDTM-IG
Legacy trial data is outputted to an SDTM target model with automated transformation available within Xbiom™, harmonized for any SDTM-IG at any time.
- SDTM target model output
- Automated transformation in Xbiom™
- Any SDTM-IG version
Firm fixed price under NDA
Share the required study documents under an NDA and we provide a firm fixed price. Sponsors have seen top programmers spend over a year on 4 legacy trials. We do it in 3 to 5 weeks.
- Firm fixed price, no surprises
- 3 to 5 week turnaround
- Protocol, CSR, CRF & SAP needed
Legacy studies are locked in PDFs
Studies done before the SDTM mandate are not available in digital form. Without digitization, there is no way to digitally analyze, search or access them.
No integrated patient profile
Most legacy trial data cannot render an integrated patient profile if a scientific query, audit or regulatory agency question needs to be answered.
Costly, slow curation
Current digital source data requires costly curation, reprocessing and time before transformation into an analysis-ready digital data repository. Prior to working with a top-ten pharmaceutical, their programmers spent well over a year digitizing just 4 legacy trials.
Document retrieval is a nightmare
Digitizing legacy clinical data can easily become a nightmare with the retrieval of study documents such as the Protocol, CSR, CRF and SAP. PointCross handles all of it.
Where it used to take over a year
PointCross Life Sciences has supported several sponsors rethinking their clinical data warehousing strategy to ensure future-proofed, analysis-ready datasets made easily available for scientific and regulatory queries.
From PDF archive to warehoused dataset
Share the required study documents under an NDA, and we take it from there.
Retrieve & digitize
We retrieve the Protocol, CSR, CRF and SAP, extract and curate the data from PDF, and build a fully structured digital dataset.
Convert to SDTM
The digital dataset is outputted to an SDTM target model using automated transformation in Xbiom™, harmonized for any SDTM-IG version.
Warehouse & analyze
The analysis-ready dataset is warehoused on a secured instance of Xbiom™ or in a target model outlet for your internal repository, ready for analysis, visualization and queries.
A broader data strategy, built on your legacy
Sponsors have requested PointCross support their digitization of clinical legacy studies to form a broader data strategy in which access to findings, stratified cohort analysis and cross-parameter analysis are readily achieved for repurposing and exploratory analysis.
Legacy data digitization, answered
Why digitize legacy clinical trials?+
How long does digitization take?+
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Your legacy studies, unlocked
Share your study documents under an NDA and we provide a firm fixed price. 3 to 5 weeks later your legacy trials are searchable, analyzable and warehoused, ready for the scientific and regulatory queries they were never designed to answer.
