ClinTrialStat Service provides services on statistical data analysis and data management for clinical trials and medical research studies. Our service includes:
Statistical Data Analysis
- Develop Statistical Analysis Plan (SAP) based on the study protocol;
- Develop Analysis Datasets Plan (ADP) to specify how to create the analysis variables derived from the CSR data based on SAP, annotated CRFs, and CDISC standards;
- Programming Analysis Datasets based on the SAP and ADP;
- Programming analysis tables, figures, and data listings based on the SAP;
- Verify Analysis Datasets and tables, figures, and data listings per independent programming based on SAP;
- Write Statistical Report on analyzed study data;
- Create Clinical Study report on all received and analyzed study data;
- Conduct exploratory data analyses per needs;
- Integrate data of multiple studies and conduct integrated statistical analysis
- Develop Analysis Plan and conduct relevant programming to implement specifically needed statistical analysis methods and complexes analysis models
- Help client to prepare regulatory agencies specifically required analysis datasets or prepare analysis tables, figures to address specifically asked questions
- Help clients to develop SAS program macros library for their internal needs
Data Management
- Develop Data Management Plan (DMP) including edits check specifications;
- Create
annotated CRFs - Create eCRF pages and Electronic-Data-Capture (EDC) data management System
- Setup study database based on the EDC or paper CRFs;
- Code adverse events to MedDRA lower level terms, using the most current MedDRA dictionary;
- Issue and resolve queries with sites for each subject’s CRFs;
- Programmatically edit check double-entry data for inconsistency, and conduct additional programmatically edit check for missing, incomplete, or inconsistent data per DMP;
- Incorporate external Laboratory transferred electronic laboratory exam data into database;
- Programmatically edit check of transferred electronic laboratory exam data for missing, repeated recorders, or out-off range data per DMP;
- Manually verify key variables from the final database against CRFs, and 100% verify of all subjects data from the final database against CRFs. The checking results will be summarized into a final database QC audit report.
- Upon completion of “Data Cleaning,” lock study database;
- Transfer data of locked study database to Siemens in a SAS and pdf formats.
Development SAS macros for Data Analysis
ClinTrialStat Service provide service on developing SAS macros for reacting tables and figures used in the report of clinical trials. These SAS macros can be integrated into SAS macro library for in SapMaker software. The users can easily select relevant SAS macros for making customized tables and figures using SapMaker Table software.
