1. Study setup
2. Study conduct
3. Study close out
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.
A LEADING POSITION AND
AN INTERNATIONAL DEPLOYMENT
64 +
countries
involved
20 000 +
investigational
Centres
3 million +
patients
in database
50 000 +
users
worlwide
September 18, 2025
September 25 – 11am – 12:30pm CEST •The meeting will start at 11.00AM o’clock.•Audio is available either through your computer or through phone connection (dial-in).•Your line will be kept on mute.•At the end, there will be time for questions and you can submit your questionsthrough the ‘question’ box.•After the webinar, connect to the EUCROF eLearnIN […]
September 18, 2025
September 23 – Namur, Belgium – Booths 26–27 Welcome to BioWin Day ! The premiere venue for doing business with Belgian health professionals, innovators and industry leaders. Explore new partnerships, see what’s evolving in biopharma and health-tech, and get a clear view of how a country as small as Belgium produces world-changing healthcare solutions. What […]
September 18, 2025
Biopharm International The bio/pharmaceutical industry is undergoing a significant digital shift, with artificial intelligence (AI) playing an increasingly vital role in achieving operational excellence and bolstering quality maturity. A strategic and well-governed approach to AI adoption is not merely an advantage but a necessity for enhancing efficiency while maintaining rigorous good practices (GxP) compliance, said […]