Clinical Data Management services

Study Setup
– Protocol & CRF reading (project familiarisation)
– Protocol & CRF Compliance check (consistency review)
– CDISC SDTM Completeness Checks
– Drug Supply Management and kits assignment linked to IWRS
– E-Platform development and validation
– E-Platform training and certification
– Creation of blank and annotated eCRF
– ECRF completion guidelines
– Data Management Plan
– Data Cleaning Plan & Programming
– Data Validation Plan
– Data Monitoring report programming
– Risk-Based Monitoring (RBM) report programming
– Setup of data export
– Data reconciliation setup
– Data exchange with external data sources and systems (in/out)

 Study Conduct
– E-Platform and database hosting & maintenance
– Data monitoring process
– Data Cleaning process & Queries Management
– Listing generation and export to support IDMC meetings
– Data coding

Study Close-Out
– Data coding
– Database pre-lock
– Final database lock, transfer and archiving
– Data reconciliation
– Data Management Report
– CDISC-SDTM mapping

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Telemedicine Technologies expert offer

Added values provided by our Clinical Data Management services
Telemedicine Technologies Belgium offers Clinical Data Management services guaranteeing the highest quality of clinical trials data and outputs resulting from seamless Clinical Data Management services that are streamlined from protocol to clinical study report.

Added values
• Vast experience in streamlined data collection and management
• Integrated Clinical Data Management services focused on quality of clinical trial data and outputs
• Telemedicine Technologies cumulates expertise covering all clinical trial phases

Added values provided by our CDISC services
In the ever-evolving and complex clinical research landscape, CDISC (Clinical Data Interchange Standards Consortium) provides critical clarity. CDISC develops data standards of the highest quality to transform incompatible formats, inconsistent methodologies, and diverse perspectives into a powerful framework for generating clinical research data that is accessible.
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.

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Data security and GDPR

Data Security
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, the integrity and the availability of data and systems.
Telemedicine Technologies software and related e-Platforms are complying 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.

GDPR
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 in order to guarantee as hoc processing of all personal data.