by Pointcross Life Sciences
Clinical data automation, standardization, and analytics for SDTM, ADaM, and SEND regulatory submissions.
Clinical & Regulatory Data Standardsby Pointcross Life Sciences
Secure data exchange and curation for clinical trials, with automated ingestion from EDC, CROs, and biomarker sources, plus data validation and traceability.
Clinical & Regulatory Data Standardsby Pointcross Life Sciences
Metadata repository with standards management, data transformation, and validation for clinical and nonclinical studies.
Clinical & Regulatory Data Standardsby Pointcross Life Sciences
Centralized repository for clinical and nonclinical study data with normalized data model, global terminology harmonization, and support for biomarker assays, animal studies, and clinical trials.
Clinical & Regulatory Data Standardsby Pointcross Life Sciences
SEND and SDTM/ADaM standardization, validation, and packaging for nonclinical and clinical regulatory submissions under 21 CFR Part 11.
Clinical & Regulatory Data Standardsby Pointcross Life Sciences
Cross-study nonclinical analytics and repository with safety, toxicology visualization, and signal discovery from harmonized study data.
Clinical & Regulatory Data Standardsby Pointcross Life Sciences
Real-time monitoring and analysis of clinical trial EDC data integrated with specialty biomarker assays for longitudinal patient insights and cohort visualization.
Clinical & Regulatory Data Standardsby Pointcross Life Sciences
Interactive visualization and tabulation of clinical and nonclinical data for generating tables, listings, and figures with longitudinal patient monitoring and cohort analysis.
Clinical & Regulatory Data Standardsby Pointcross Life Sciences
Validation of clinical SDTM, ADaM and nonclinical SEND datasets for FDA, PMDA and CDISC submissions.
Clinical & Regulatory Data Standards
by CIMS Global
Validated R and RShiny analytics environment for compliant clinical data analysis and interactive dashboards.
Clinical & Regulatory Data Standards
by Instem
SEND dataset creation and management for regulatory submissions in preclinical studies.
Clinical & Regulatory Data Standardsby Instem
Cloud-based statistical computing environment for clinical trial data analysis, pre-loaded with SAS, R, Python, and validated for FDA/GxP compliance.
Clinical & Regulatory Data Standardsby Instem
Cloud-based statistical computing environment for clinical data analytics, with automated compliance, multi-language support, and scalable workflows.
Clinical & Regulatory Data Standards
by Certara
Clinical data standardization and validation for regulatory submissions.
Clinical & Regulatory Data Standardsby Certara
Visualization and analysis of nonclinical study data in SEND format for identifying trends and outliers.
Clinical & Regulatory Data Standards
by PointCross
Study data automation, standardization, and analytics for clinical and nonclinical research with AI-assisted data discovery.
Clinical & Regulatory Data Standardsby PointCross
Data standardization and packaging for nonclinical SEND and clinical SDTM/ADaM regulatory submissions under 21 CFR Part 11.
Clinical & Regulatory Data Standardsby PointCross
Unified study report and SEND dataset generation from LIMS, pathology, and bioanalytical data—delivering compliant submissions 2+ weeks faster.
Clinical & Regulatory Data Standards
by eClinical Solutions
Data mapping and standardization from any source without programming, using drag-and-drop transformation to SDTM and other clinical data standards.
Clinical & Regulatory Data Standardsby eClinical Solutions
Centralized statistical analysis with automated workflows, version control, and support for SAS, R, and Python programming.
Clinical & Regulatory Data Standards