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
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February 17, 2023
Fierce Biotech The nonprofit Digital Medicine Society and a slew of industry collaborators have launched a new resource platform designed to advance diversity, equity and inclusion (DEI) in digitized clinical trials. About 80% of current clinical trial patients are white and only 45% or women, according to the society, illustrating the huge gap that has grown into a […]
January 19, 2023
Telemedicine Technologies continues to acquire companies that provide innovative solutions and services to its customers. The acquisition of the CTMA (Clinical Trials Mobile Application) software suite enables Telemedicine Technologies to offer investigating centres assistance to accelerate patient recruitment in clinical trials, and to ensure their commitments to sponsors. The digital transformation of healthcare institutions is […]
December 19, 2022
Fierce Biotech Trialbee, a patient enrollment company, inked a partnership deal with Acclinate in a push to accelerate wider patient diversity in clinical trials. Under the partnership, Sweden-based Trialbee will get access to Acclinate’s NOWINCLUDED offering that engages diverse populations on health-related issues, the company said in a Dec. 13 press release. Founded in 2020, Birmingham, Alabama-based […]