HLT team has gained profound experience in both local and global projects in statistical analysis, statistical programming and data management. We are proficient in complex statistical design and innovative data management. Also, we developed automated study design tools, centralized data monitoring and intelligence visualization platform. And we demonstrate automatic, intelligent clinical data analysis, and provide a high-efficacy, rapid professional service based on global standard.
Data Management Services from Phase I to Phase IV Clinical Trials
CRF/eCRF design
Database design，development and maintenance（EDC&RTSM&ePRO)
Data management plan & All related documentation
Data review and query management
Medical coding(MedDRA & WHO Drug)
SAE reconciliation
External data handling and reconciliation
Data management status reports
Quality control
Database lock
Data extraction and transfer
Multiple therapeutic areas CRF library
Automated medical coding, CTCAE/Recist standard data review tools
Centralized Data monitoring (CDM) metrics and Quality Tolerance standard (QTL) management
Clinical trial data quality system& Software management consulting
Deploy and implement eSource and EMR data interconnection
Clinical development plan and strategies
Statistical model building and simulation
Protocol/Trial design/Sample Size Planning
Randomization Scheme
Centralized statistical monitoring, data trend analysis and risk monitoring
Exploratory analysis, sensitivity analysis, ISS/ISE
Statistical Analysis Plans (SAPs)
Topline Report Ceneration
Statistical Analysis Report (SAR)
Statistical Result Interpretation
Data and report delivery services
iDMC Statistical support (blind and unblind)
Observational Studies/RWE
Strategic Consulting and Independent Third-party Review
Development of submission-ready datasets and supporting documents in CDISC format: Annotated CRF, SDTM, ADaM, Define.xml and Reviewer’s Guide
Tables, Listings, and Figures Development and Quality Control
Data Monitoring Committee (DMC), Safety Committee and Interim Analysis Support
Generation of pooled datasets and TFLs for Integrated summary of efficacy and safety (ISE/ISS)
Rapid regulatory response outputs
Pharmacokinetic and pharmacodynamic data analysis and modeling.
Annual Clinical Trial Safety Updates(investigator brochures, DSURs etc.)
Support of patient profiles & ad-hoc reports, as well as data review and monitoring tools such as Tableau or R Shiny
Office of Scientific Investigation (clinsite.xpt, define.xml,reviewers guide, and OSI listings)
Functional Service Provider Solutions
津公网安备 12011502000526号