TRIALCOMPLETE
The TrialComplete data management system makes it possible for clinics, universities, and the pharmaceutical industry to do research anytime and anywhere. The use of Telekom’s ISO/IEC 27001 certified data centers which of course meet the requirements of the General Data Protection Regulation (GDPR), ensure security at all times. The Science Edition integrates large image data sets from multicentric networks into one data management system, providing researchers with flexible analysis and exchange functions. The Early Phase Edition is optimized for highly configurable process controls and data collection in the early phases of medication approval studies.
CLINICAL DATA MANAGEMENT SYSTEM
TrialComplete Science Edition manages and archives clinical study data, including image data in DICOM format. The web-based work environment facilitates for research teams from universities, clinics, and the pharmaceutical industry to process multicenter, pseudonymized image data without media disruption. TrialComplete Early Phase Edition (TCEP), on the other hand, is a data management system that simplifies the organization of complex clinical studies—particularly the three-phase approval process for medications.
Science Edition
The online portal provides access to research data from different studies and is scalable to any size of study. This means that the cost can be planned transparently. The data is transferred to a secure long-term archive from which it can be easily imported into other systems.
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Early Phase Edition
The TrialComplete Early Phase Edition (TCEP) data management system is designed for running short studies and controlling study processing in a timely manner in the early phases. For organizations that span countries and continents, it supports decentralized, consolidated data processing.
HIGHLY INTEROPERABLE
The data management system is based on CDISC ODM/SDM models, an established standard for study design and for exchanging study data, importing study designs from external sources, and synchronizing work between various user groups.
SECURE PSEUDONYMIZATION
Trial Connect separates identifying information from medical data exclusively by means of pseudonyms. An embedded iFrame of an external pseudonymization service sorts subject according to their identifying data.
INTEGRATED DATA PROCESSING
TrialComplete processes multicenter, pseudonymized image data without media disruption, from upload to storage in clinical forms, connecting to the local PACS, pseudonymization of data, and secure Internet connectivity.
NUMEROUS INTERFACES
The essential objective of TrialComplete is the integration into customer-specific system landscapes. Interfaces are provided for comparing data with external CDMS systems or for pseudonymizing via iFrame from external service providers.
CONVENIENT REPORTING
The data management system has an integrated report management function as a convenient option for getting study information. In this way, many existing reports can be generated in Excel and/or PDF format.
EFFICIENT SUBJECT MANAGEMENT
The Early Phase Edition collates subject data from prior study participants in a separate subject management module, gives suggestions for inviting subjects, and organizes subjects into cohorts.
SPECIFIC PROCESS CONTROLS
While most clinical studies focus on data acquisition in eCRFs (electronic case report forms), they are closely linked to the processes to be performed in early phases and can be easily controlled via Trial Connect.
SIMPLE INTEGRATION OF DEVICES
TrialComplete has an interface framework that can be used to transfer data from medical measurement devices (scales, blood pressure, ECG, etc.) into the procedures. This ensures that data can be processed without media disruption.
SPECIALIZED LAB MODULE
The lab module from TCEP simplifies the use of datasets by creating and sending lab orders and accompanying documentation, or by accepting lab results from several external labs and presenting them to the study physician in charge.
CLEARLY ORGANIZED MASTER DATA
TCEP manages master data in libraries and catalogs in any desired language including self-selected, internationalized date and time as well as UTC times.
VALIDATION SUPPORTED
TrialComplete Early Phase supports research-based pharmaceutical companies in the validation process, for example by using a software development life cycle that is organized and documented according to GAMP 5, or through pre-validation of software and operation under software as a service.
CONVENIENT REPORTING
The data management system has an integrated report management function as a convenient option for getting study information. In this way, many existing reports can be generated in Excel and/or PDF format.
Reference "Hannover Medical School"
TrialComplete Early Phase Edition
TrialComplete Science Edition
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