Quality of Data through comprehensive clinical Data Management
1. Study setup
Input in CRF design
Creation of annotated CRF
Data Management Plan (DMP)
Data Cleaning Plan (DCP) & Programming
2. Study conduct
E-Platform and database hosting
Handling reference ranges
Data Cleaning Process
(Risk-based) Data Monitoring
3. Study close out
Data reconciliation across multiple sources and systems
Database lock, transfer & archiving
Data Management Report
As a CDISC expert, Telemedicine Technologies offers high quality Data Management services.
CDISC creates clarity in clinical research by bringing together a global community of experts to develop and advance data standards of the highest quality. CDISC enables the accessibility, interoperability and reusability of data for more meaningful research that has greater impact on global health. Based on the development of its own data collection and clinical data management tools, Telemedicine Technologies has seamlessly built processes to apply CDASH and ODM* standards during eCRF & database design and export.
Based on ODM standards, Telemedicine Technologies has built cutting-edge tools that allow for compliance with SDTM* standard.
Based on ODM data collected in the eCRF, Telemedicine Technologies provides SDTM mapping which will then be transferred to biostatistics for further analysis resulting in ADaM datasets. The SDTM datasets generated by Telemedicine Technologies are provided together with a SDTM Mapping Guide (which defines the mapping between collected data and CDISC domains), a SDTM Annotated CRF and a define.xml which describes the metadata of the SDTM package.
* ODM (Operational Data Model) is a recognised Operational Data Model for data collection, exchange and archiving. Based on ODM standards Telemedicine Technologies has built cutting-edge tools that allow for compliance with SDTM* (Study Data Tabulation Model) standard.
* SDTM (Study Data Tabulation Model) provides a standard for organising and formatting data to streamline processes in collection, management, analysis and reporting. SDTM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan). Based on ODM data collected in the eCRF, Telemedicine Technologies provides SDTM mapping.
Telemedicine Technologies has been processing electronic data for the clinical research industry for over 2 decades. Telemedicine Technologies Standard Operating Procedures (SOPs) and software are built to address and ensure the confidentiality, integrity and availability of data and systems. Telemedicine Technologies software and related e-Platforms comply with GAMP-5 guidelines, FDA 21 CFR Part 11 recommendations, ICG E6 (R2). All communications and data are encrypted. Study documents are stored in secured and password-protected systems. Systems and data are backed up on a daily basis and policies are in place for retention and to ensure integrity and security of the backups.
Telemedicine Technologies fully complies with the EU General Data Protection Regulation 2016/679 of 25th May 2018 and certifies that all procedures are in place to guarantee ad hoc processing of all personal data.
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