The TrialComplete data management system provides a long-term, secure way to manage and archive research and study data.
Solution

TrialComplete

Data management system for research – independent of time and place

The TrialComplete clinical data management system (CDMS) collects and organizes data from pharmaceutical, biomedical, and clinical studies. Security is guaranteed through the use of ISO/IEC 27001-certified data centers operated by Deutsche Telekom, which of course satisfy the requirements of the General Data Protection Regulation (GDPR).
  • The Science Edition integrates high-volume sets of images from multicentric networks in a single data management system and gives researchers flexible analytics and sharing features.
  • The Early Phase Edition is optimized for highly-configurable process control and data collection in early studies for drug approvals.

TrialComplete Science Edition: Clinical documentation and process efficiency

The TrialComplete Science Edition makes it possible to manage and archive clinical data including (image) data in DICOM format. The web-based work environment makes it easy for research teams at universities, hospitals, and pharma companies to process multicentric, pseudonymized image data without media fragmentation. Research data can be collected, shared, rated, and analyzed more efficiently. The location-independent data management system is scalable for studies of all sizes, providing transparent cost planning and control. The recorded research data can be transferred into a protected long-term archive, from which it can be easily migrated to other systems.
TrialComplete Science Edition
TrialComplete is an online portal that gives virtual users from study institutions cross-study access – upon authorization – to research and study data:
  • Information about incoming messages (such as confirmations of image data uploads or references to received questions and queries)
  • Management of tasks to be performed (such as signatures and monitoring of forms, approval of image documents)
  • Processing of queries (user involved as enquirer, direct recipient, or member of a recipient group)
Based on CDISC ODM/SDM models, the data management system provides an established standard for study design and for sharing study data:
  • Import of study designs from an external source, as well as manual creation in an Excel worksheet and download for external further use
  • Synchronization of work by different groups of users in separate systems through configurable, bi-directional data exchange with the external CDMS
The strict separation of medical and identifying data is achieved in TrialComplete through the sole use of pseudonyms:
  • Customer-specific, embedded iFrame with an external pseudonymization service for the assignment of volunteers based on identifying data
  • If no interface to the pseudonymization service is available users can access test subjects through known pseudonyms
TrialComplete supports the processing of multicentrically created, pseudonymized image data free of media fragmentation – from uploading to data storage in the clinical forms:
  • The TrialComplete Upload Client enables the uploading of DICOM image data as local files, without prior installation.
  • The optional TrialComplete Gateway software establishes a connection to the local PACS – image data can be directly retrieved and uploaded from there.
  • The uploaded image data is uniquely assigned to a test subject examination.
  • Image data is pseudonymized based on a customer-specific profile and uploaded to the TrialComplete Server through a secure Internet connection.
  • DICOM images from the TrialComplete Browser are displayed using the integrated viewer.
  • The DICOM viewer enables the measurement of image data using standard measurement methods, as well as experimental, customer-specific algorithms, along with the automatic transfer of measurement data to configured (electronic) clinical report forms (eCRFs).
A key feature of TrialComplete is its integration in customer-specific system landscapes. The following interfaces are available, among others:
  • Data exchange with external CDMSes
  • Pseudonymization from other service providers possible via iFrame
  • Authorized systems (such as external image processing or report tools) can retrieve study and image data from Trial Connect via REST interfaces
A report management feature is integrated in the data management system as a convenient option for outputting study information. This method makes it possible to generate a variety of existing reports in Excel and/or PDF format, as well as generate new reports.

TrialComplete Early Phase Edition: Subject management, process management, and validation support

In contrast, the TrialComplete Early Phase Edition (TCEP) data management system simplifies the organization of complex clinical studies – particularly the three-phase approval process for drugs. It is designed for conducting brief studies and coordinating process schedules of studies in early phases. Organizations spread across multiple countries and continents can elect to use decentralized, consolidated data processing in the worldwide data centers of Deutsche Telekom and its partners. This approach guarantees productivity and performance in all regions. At the same time, the clinical study documentation system enables a pan-organizational overview of all studies, while the individual centers and users work on their studies based on their own roles and permissions.
TrialComplete Early Phase Edition
Subject management is very important in the early stages of studies, in particular, because volunteers often take part in studies repeatedly. As such, the corresponding features have been integrated in the Early Phase Edition:
  • Consolidation of volunteer data from previous study participation in modularly delimited subject management
  • Targeted suggestion of volunteer invitations (waiting period after last study, known matches with inclusion/exclusion criteria) and management of responses
  • Organization of volunteers in cohorts for joint execution of studies
While most clinical studies focus on recording data in eCRFs (electronic case report forms), in the early phases, they are closely linked with other processes, which can be easily controlled with TrialComplete:
  • Creation and reuse of custom eSource CRFs and their components, in line with the CDISC standard
  • Customer configuration of workflows (such as the study cycle or status transitions of volunteers)
  • Adaptation of procedures (such as blood sampling, examinations, lab work), including time dependencies and conformation (such as scan of employee ID card, password entry at the beginning or end of the procedure) and specification of work steps
TrialComplete features an interface framework that enables the inclusion of data from medical measurement devices (scales, blood pressure, ECG, etc.) directly in the procedures. This ensures that all data can be processed free of media fragmentation.
Laboratory data is a crucial, data-intensive part of clinical trials. The lab module of TCEP simplifies the handling of these complex datasets:
  • Creation and dispatch of lab orders and accompanying documentation within the corresponding procedures
  • Accept lab results from multiple external laboratories and submit them to the responsible clinical physician for review
  • The clinical physician can reject the data, send it back to the lab for another review, or accept it – thus adopting it in the involved eCRF
TCEP makes it possible to manage master data in libraries and catalogs:
  • Use of any language, including internationalization of user-maintained date and time formats
  • Use of UTC times
Researching pharmaceuticals companies and contract research organizations (CROs) are responsible for validating their processes for the FDA (U.S. Food and Drug Administration) and/or the EMA (European Medicines Agency) – the use of TrialComplete Early Phase is no exception. In this regard, the solution supports validation through:
  • A software development life cycle organized and documented in compliance with GAMP 5.
  • A modular approach that restricts the scope of validation after updates of sub-components, by risk assessment.
  • Pre-validation of the software and operation as software-as-a-service in the framework of Telekom Healthcare Solutions-internal quality assurance and release ("Validation Package" with release certificate and accompanying documentation).
  • Professional customer service.
A report management feature is integrated in the data management system as a convenient option for outputting study information. This method makes it possible to generate a variety of existing reports in Excel and/or PDF format, as well as generate new reports.