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The data management service provides the whole process services from CRF design, database construction,testing, maintenance,account management, data cleaning,medical coding,external data consistency check, SAE consistency check,document management,database locking and so on.
CRF Design/CRF Review
Data Management Plan
Database Set up （CDISC Standard）
Data Collection (paper CRF/multiple EDC systems)/Progress Report
Data Validation Plan
Data Query Management/ Protocol Violation List/Patientt Important Information Summary
Project Document Management
Data Management Outsourcing
1、The data management team has experience in data management for 14 years, and has accumulated experience in the design of p-CRF and eCRF for various tests during this process,forming the company's database.And all aspects of data management will be standardized and systematic.CRF design plans will be quickly provided for ethical submission,and the verification program embedded in the system during the test process will quickly help clean up the data.
2、We are Oracle's long-term partner having the permanent rights to Oracle's OCRDC system which is maintained by the company's IT department.We have a dedicated ERVICE HELPDESK 400 hotline to answer customers' needs and questions with tracking and feedback on each issue. For new users of the system, we provide EDC training.For the completed project,we will continue to provide the database retention service for the applicant. After the project is completed, the applicant can also apply to enter the system to view the data.
3、The responsible person of the project will interface with the applicant for each project in data management.And the quality control will be permeated all aspects of data management.The construction of the database has been tested and approved before going online,both in the interface and in the verification program. The management of questioning has regular summary reports to monitor,which works closely with the clinical team and CRC team to solve problems in data cleaning in a timely manner.For documents in data management, there are special QA personnel other than the project team who will check the documents twice before they are delivered to the applicant.