Leading Edge CDM Solutions
Clinical data management and clinical research services provider founded in 2014. Offers end-to-end clinical data management, electronic data capture (EDC) implementation and programming, clinical IT/integration, biostatistics, and statistical programming. Operated with distributed teams across the USA, Europe, Russia, and Asia. As of July 1, 2024 the company was acquired by Hart Clinical Consultants, LLC.
Industries
Nr. of Employees
small (1-50)
Leading Edge CDM Solutions
Foster City, CA 94404, USA
Products
Data Management
Offers services such as CRF/eCRF design, data validation checks, data query management, and medical coding to ensure quality clinical data management.
EDC Programming
Provides EDC system selection, database build and validation, and user management to support clinical trials.
Clinical IT
Builds interfaces between clinical databases and supports other clinical systems with process optimization and solution implementation.
Biostatistics
Involves study design, data analysis, and regulatory submission support using scientific principles and therapeutic knowledge.
SAS Programming
Develops and tests SAS programs for complex analyses, producing submission-ready datasets and associated documentation.
Data Management
Offers services such as CRF/eCRF design, data validation checks, data query management, and medical coding to ensure quality clinical data management.
EDC Programming
Provides EDC system selection, database build and validation, and user management to support clinical trials.
Clinical IT
Builds interfaces between clinical databases and supports other clinical systems with process optimization and solution implementation.
Biostatistics
Involves study design, data analysis, and regulatory submission support using scientific principles and therapeutic knowledge.
SAS Programming
Develops and tests SAS programs for complex analyses, producing submission-ready datasets and associated documentation.
Services
End-to-end clinical data management services including CRF/eCRF design, validation checks, query management, AE/SAE reconciliation, medical coding, device accountability, and production of data listings and reporting.
EDC and supporting software selection, database build, amendments and migrations, database validation, EDC training, user and site management, and lab/other data uploads.
Design and implementation of interfaces between clinical databases and other clinical systems; process optimization, vendor assessments, implementation, testing, validation and reconciliation.
Statistical design and analysis services including protocol statistical sections, randomization, sample size estimation, SAP development, analysis and reporting, and regulatory support.
Development and testing of SAS programs for complex analyses and production of CDISC-compliant SDTM and ADaM datasets and documentation.
End-to-end clinical data management services including CRF/eCRF design, validation checks, query management, AE/SAE reconciliation, medical coding, device accountability, and production of data listings and reporting.
EDC and supporting software selection, database build, amendments and migrations, database validation, EDC training, user and site management, and lab/other data uploads.
Design and implementation of interfaces between clinical databases and other clinical systems; process optimization, vendor assessments, implementation, testing, validation and reconciliation.
Statistical design and analysis services including protocol statistical sections, randomization, sample size estimation, SAP development, analysis and reporting, and regulatory support.
Development and testing of SAS programs for complex analyses and production of CDISC-compliant SDTM and ADaM datasets and documentation.
Expertise Areas
- Clinical data management
- EDC implementation and database programming
- Clinical IT and system integration
- Biostatistics and study design
Key Technologies
- Electronic data capture (EDC) systems
- EDC database build and migration
- Database validation and user acceptance testing
- CDISC SDTM and ADaM standards
News & Updates
Public event listing for a technology-focused conference held in San Francisco.
Leading Edge CDM Solutions was acquired by Hart Clinical Consultants, LLC.
Public event listing for a technology-focused conference held in San Francisco.
Leading Edge CDM Solutions was acquired by Hart Clinical Consultants, LLC.