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

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

Biostatistics consultation

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

Statistical Programming
Statistical Programming
Our programming team provides comprehensive service support throughout all stages of clinical development to improve data quality, optimize results, and reduce risks.

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