Castor CDMS is your clinical data management system for validation, query management, SDTM alignment, and database lock. Built natively on the same platform as Castor EDC, there is no data handoff, no migration, and no middleware between your collection layer and your management layer.
Castor EDC captures clean data from your sites and patients throughout the trial. This is where study forms, ePRO assessments, and visit schedules live.
Castor CDMS takes that data through query management, SDTM alignment, and database lock. Because both systems share the same platform, the data flows directly between them with no export and no re-ingestion.
You spent weeks collecting clean data in your EDC. Then you exported it, reformatted it, and loaded it into a separate CDMS before validation could begin. That handoff costs time and introduces transcription risk every time.
When edit checks are set up at the point of data entry, queries become exceptions, not routine work. When they are not, your data managers spend most of their day tracking down answers to questions that better validation rules would have prevented.
When SDTM dataset alignment is planned at submission time rather than built into the data structure, it becomes a compressed, high-stakes task at exactly the moment the team is most fatigued. This is avoidable.
Built to stay current with regulatory expectations from FDA 21 CFR Part 11 through CDISC SDTM submission.
Configurable edit checks flag errors, inconsistencies, and out-of-range values at the point of data entry. Rules are set by the data manager, not the vendor, and applied without raising a support ticket.
Full query lifecycle in one place: automatic query generation, site response workflow, query resolution, and audit trail. Query status is visible to sponsor and site in real time.
Systematic identification and resolution of missing data fields before database lock. Configurable rules define which missing data requires active resolution versus what can be left as an acceptable gap.
SDTM mapping built into the data structure, not retrofitted at submission time. Supports CDISC ODM and SDTM datasets for FDA and EMA submissions. Define.xml generation included.
Direct export to SAS and R without manual data reformatting. Export configurations are version-controlled and reproducible, so the same dataset can be regenerated at any point in the study timeline.
Controlled database lock process with role-based authorization, full audit trail of all changes, and lock documentation formatted for regulatory inspection readiness.
Export packages formatted for FDA eSub, EMA, and PMDA submission requirements. Define.xml generation and dataset validation are part of the standard export workflow.
Integration with MedDRA and WHODrug for adverse event and medication coding within the CDMS workflow, with coding status tracked in the query management system.
Castor CDMS and Castor EDC run on the same platform. Data flows from collection into management without an export, an import, or a middleware layer between them. No mapping. No version conflicts. No handoff delay.
See how Castor automates the journey from patient recruitment to submission-ready RWE data, while ensuring quality through rigorous human validation and risk-based quality management9.
From the moment data leaves your site to the day your submission package is complete, Castor manages the entire workflow. No separate system. No data migration between collection and management.
With active Castor studies
Across all Castor studies
126+ verified user reviews
Traditional approaches solve only one piece of the puzzle. Castor Catalyst is the only unified clinical trial software platform that delivers regulatory-grade RWE data and the infrastructure to operationalize it.
Multi-center prospective study with 4,992 participants across 8 sites. Managed over 427,000 data points via combined eCRF and ePRO without a data handoff.
Natural history studies for neurodegenerative diseases. Longitudinal cognitive assessments and disease progression tracking.
Patient registries for ultra-rare conditions. Direct-to-patient enrollment and natural history data collection across global populations.
Castor’s professional data management services team works directly inside the platform. No tool-switching, no coordination overhead, no intermediary layer between your data and the people managing it. They know the system because they helped build it.
A clinical data management system (CDMS) is software used to prepare, validate, and analyze clinical trial data after it is collected and before it is submitted to regulatory authorities. CDMS capabilities typically include data validation rules, query management, missing data reconciliation, medical coding, SDTM/CDISC alignment, and database lock. The CDMS sits between the data collection layer (EDC) and the regulatory submission package.
An electronic data capture system (EDC) collects data from sites and patients during a trial. A clinical data management system (CDMS) receives that data after collection and manages the process of validating, cleaning, coding, and structuring it for regulatory submission. In a two-vendor setup, data must be exported from the EDC and imported into the CDMS, which introduces a migration step and potential for transcription errors. Castor EDC and Castor CDMS operate on the same platform, eliminating that handoff entirely.
A clinical data manager is responsible for the integrity, accuracy, and regulatory compliance of clinical trial data from collection through submission. Their work includes configuring data validation rules, managing queries raised against site data, reconciling missing or inconsistent data, overseeing medical coding, aligning datasets to SDTM standards, executing the database lock process, and delivering the final submission-ready dataset to the regulatory authority.
Clinical data management is governed by several overlapping standards. FDA 21 CFR Part 11 covers electronic records and signatures in clinical research. ICH E6(R3) outlines Good Clinical Practice (GCP) requirements for data quality and audit trails. CDISC SDTM defines the dataset format required for regulatory submissions to FDA, EMA, and PMDA. GDPR governs personal data handling for participants in EU-based studies. Castor CDMS is designed to operate within all four frameworks.
Castor CDMS natively supports CDISC ODM-XML (version 1.3.2) for both study structure and data export/import. SDTM mapping is built into the data structure rather than being retrofitted at submission time, and datasets can be exported asynchronously for regulatory submission prep. The system also generates define.xml files as part of the standard export workflow.
Castor CDMS exports directly to SAS formats (SAS XPT and SAS 7BDAT). For R users, Castor provides a dedicated API package (castoRedc) that pulls study data directly into R for analysis without manual reformatting. Export configurations are version-controlled, so the same dataset can be regenerated at any point in the study timeline, which matters for inspections and audits.
Castor CDMS exports directly to SAS formats (SAS XPT and SAS 7BDAT). For R users, Castor provides a dedicated API package (castoRedc) that pulls study data directly into R for analysis without manual reformatting. Export configurations are version-controlled, so the same dataset can be regenerated at any point in the study timeline, which matters for inspections and audits.