From first entry to database lock
A predictable database lock is determined by the controls applied throughout study conduct. Alethium's data managers work with data that arrives structured, timestamped, and associated with the event that produced it, reducing reconciliation effort and shortening the path to submission-ready datasets.
Database Design & Build
Study databases designed from the protocol, with edit checks and validation rules expressed as the same plain-language scenarios that govern the rest of the study.
Data Validation
Validation executes at the point of capture rather than in scheduled batches, so discrepancies are identified while the participant remains at the site.
Query Management
Studies that transition to Alethium continue on our Clinical Data Platform, where every subsequent action is captured as immutable evidence. Studies that stay where they are get the remediation plan regardless.
External Data Reconciliation
Lab results, device and wearable data, imaging, and vendor files ingested, reconciled against the study record, and resolved.
CDISC Datasets
Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets produced to CDISC standards with Define-XML and reviewer guides, submission-ready by construction rather than by remediation.
Database Lock
Lock executed against a documented checklist, with every prerequisite verifiable in the study record. Post-lock changes are controlled and fully traceable.
Data Managed Where It Is Created
Our data managers work in the same system that captured the data. There is no extract, no staging copy, and no reconciliation between the operational record and the analysis record, because they are the same record.
Captured. Verified. Locked.
Submission-ready data, traceable to the moment it was captured.
FAQs - Common Questions
Alethium's data management covers database design and build, validation rules and edit checks, query management, medical coding to MedDRA and WHODrug, reconciliation of external data such as lab and device results, CDISC dataset production, and database lock.
Yes. Our team codes adverse events, medical history, and concomitant medications to MedDRA and WHODrug, documents coding decisions, and applies them consistently across the study so the coded data holds up under review.
Yes. Data structures are CDISC-aligned from the design stage, so SDTM and ADaM datasets are produced by construction rather than remediated before submission. Define-XML and reviewer guides are delivered with the datasets.
Validation runs at the point of capture rather than in batches, so most errors are corrected while the participant is still at the site. Data arrives structured and timestamped, tied to the event that produced it, which removes the reconciliation work that usually dominates the weeks before lock.
Yes. Lab results, wearable and connected device data, imaging, and vendor files are ingested and reconciled against the study record. Discrepancies are raised as queries and resolved through the same workflow as any other data issue.
Lock is executed against a documented checklist with every prerequisite verifiable in the study record. Any post-lock change follows a controlled process and is captured in the audit log, so the reason for the change and its authorization are permanently traceable.
