The Service Content
Stem - Make The Future With Heart

Data Management

Detailed

Stem's data management team is located in Shanghai, Beijing, Shenyang, xi 'an and other cities. It is a dedicated and professional team. In check for the clinical trial data and cleaning process, we comply with GCP, guide clinical trial data management technology, drug clinical trial data management and statistical analysis plan and reporting guidelines, clinical trials of electronic data acquisition technology guidelines, through standardized management, providing customers with accurate and complete clinical trial data.

  • Data management services:

    CRF design;

    Database page and logical verification tests;

    Data management plan formulation and data verification plan formulation;

    Writing guidelines for filling in the case report form;

    Data verification and cleaning;

    Consistency verification of serious adverse events;

    External data management;

    Local laboratory data management;

    Medical coding;

    Data quality control;

    Data management report writing;

    Database locking;

    Data extraction and transmission, etc.

Database Building

Detailed

Stem implements the database construction service with high requirements and standards, and the stable high-quality database construction team in line with CDISC standard provides the professional and customized services required by customers. Stem cooperates with the internationally renowned EDC system Medidata, Oracle and Cube, and has the database construction capacity of Medidata and Cube to save costs and improve work efficiency for the bidders.

  • Data database building services:

    EDC construction and testing;

    Logic check programming and testing;

    Maintenance of normal laboratory value;

    Guiding of the EDC fill out.

SAS Programming And Statistical Analysis

Detailed

With many years of project experience at home and abroad, Stem statistical team members conduct data analysis of the entire clinical trial program according to the CDISC standards and follow the various FDA/CFDA guidelines and standard operating procedures to ensure accurate assessment of drug safety and efficacy.

  • SAS programming service content:

    Design and write SAS verification program according to data verification plan

    Provide data list according to DM requirements

    Write statistical analysis program according to SAP

    Develop, maintain and test SAS macros based on data management and analyst requirements

    Output the data audit list according to the data audit plan

    Assist data administrator to provide SAS programming support

    Independently check other programmers output charts and lists

  • Statistical analysis services:

    Audit program statistics related content

    CRF review

    Sample size estimation

    Randomization and blind implementation

    Statistical analysis plan (SAP) writing

    Statistical analysis report (SAR) writing

    Review the data audit report, discuss the violation of the scheme, and put forward the opinions on data set division

    Review the SAS program for statistical analysis of charts, lists, etc.

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