Statplus Service   >  Clinical Trial   >  Data Management

Data  Management

StatPlus offers comprehensive data management services,  covering all aspects of the process, which include: 

1. eDC System:
StatPlus mainly utilize Electronic Data Capture (eDC)  system to collect and review data in real-time, allowing faster identification and resolution of data issues. Additionally, different role-based permissions allow for  maintaining data accuracy on the eDC system, as well  as performing functions such as randomization and  e-diary.

2. Database setup:
The initial step in data management, where screens and forms are generated to collect data  from various sources. The database is set up to store  and manage the collected data, with built-in edit checks as the first layer of identifying the accuracy of the  entered data.

3. Completion guideline and eDC training:
Through clear  procedures and training, investigators and study nurses  are able to collect and report data accurately.  

4. Double data entry:
A process in which the data are entered twice by different personnel to ensure accuracy and consistency. 

5. Periodical data review and query resolution:
During the periodical data review, StatPlus reviews the collected  data to identify any discrepancies or errors that may have occurred during data collection or entry. Queries are then generated and sent to trial monitors/investigators for resolution. This process helps ensure data accuracy and completeness, which is critical for the success of the study. 

6. Data verification and validation:
A thorough review of the data to ensure accuracy, completeness, and consistency. 

7. CDISC-SDTM services:
StatPlus provides professional CDISC-SDTM services to clients, ensuring that their data are compliant with industry standards. Our experienced team follows a rigorous process to transform study data into a standardized format, facilitating seamless integration with other studies and easier regulatory submissions. 

8. Adverse event coding:
Adverse events will be coded according to the sponsor's specified dictionary. 

9. Database finalization:
The database is finalized for analysis after all data queries and resolutions have been completed.