eSource and automation for early phase studies
TrialComplete EarlyPhase is the all-in-one solution for the efficient preparation, workflow-driven conduct and comprehensive reporting of Phase I and IIa clinical trials.
esource and automation for early phase studies
With TrialComplete EarlyPhase, clinics and other stakeholders work with a modern solution for collecting and managing study data that is specifically tailored to early phase studies.
TrialComplete EarlyPhase (TCEP) is a specialized system for data collection and process control in clinical trials that has been developed specifically to meet the requirements of Phase I/IIa study sites.
Study builders digitally map the processes required in the study protocol and then clinic staff record study data as they are generated, in real time, typically through barcode-driven workflows and with integrated medical devices and laboratories. The goal is to go paperless as much as possible.
The highly flexible design of the study setup encourages protocol compliance, a reduction in missing data points and the almost complete removal of the need for transcription. A comprehensive database of test subjects accelerates the recruitment process. CDISC-based data formats are available for export and streamline data management of clinical trials. Deploying as SaaS (Software-as-a-Service) from Deutsche Telekom Cloud's data centers enables secure, single site, or multisite trial execution and global data access, fostering efficient collaboration between study sites and medical teams. The use of this common database allows a uniform study setup, standardised study execution and uniform data exports, while preserving site-specific characteristics (e.g. local laboratory, assignment of user rights, etc.). Flexible configuration options allow adaptation to local Standard Operating Procedures (SOPs) to accommodate the greatest possible harmonization in larger organizations. CROs benefit from the ability to leverage libraries with sponsor-specific procedures.
The system, which was developed together with users with hands-on experience, and according to regulatory standards, is highly configurable and meets all requirements for GCP-compliant use.
The early phases of clinical research (Phase I/IIa) require quick, efficient and accurate collection of study data. TrialComplete EarlyPhase (TCEP) offers exactly that: a specialized platform for the requirements of Early Phase teams.
TCEP supports…
- … the recruitment of study subjects through a comprehensive database of past participants and potential future subjects, separated from the trial data, and managed according to the expectations of local privacy laws, including GDPR
- … the protocol-compliant study setup – with the use of pre-defined and approved procedures for data acquisition (CDASH) using a flowchart-like approach and precise timing sequences, instrument-supported measurements, electronic laboratory communication and accurate sample management in the internal laboratory
- … the automated execution of clinical processes, including their complete documentation and audit trail, using barcoded process monitoring
- … enhanced protocol compliance and data integrity through minimization of manual entries, real time edit checks, connection of medical devices, and the recording of all clinical data in one system
- … the regulatory compliant recording of all processes (ALCOA)
- … global deployment as a browser-based solution (SaaS model)
- CDISC-compliant export of study data for data management and EDC systems
TrialComplete EarlyPhase was created for clinics and contract research organizations (CROs) that are active in the early phase of clinical development (EP) and need an integrated system of eSource data capture and automation in clinical trials.
For example, TrialComplete enables efficient management of study sites for single- and multisite studies. Through a uniform study setup, harmonized processes and standardized data export, site-specific variations, such as local laboratories or the assignment of user rights, are considered. This is especially important for international studies, where flexible configuration options offer the possibility of adapting to local requirements. In addition, any foreign language can be individually adapted with the help of preconfigured and custom catalogues. For larger organizations, TrialComplete is a valuable tool for harmonization. CROs benefit from a common database and libraries that allow sponsor-specific procedures to be efficiently managed, used and re-used.
In summary, TrialComplete Early Phase offers a comprehensive end-to-end solution for the conduct of early-phase studies. The solution, which is provided as Software-as-a-System (SaaS), is made available pre-validated, which significantly reduces the effort for user validation. The structuring of the system along functional-specific workflows with local configuration also minimizes the effort for user training and SOP adaptation.
The system is hosted securely and expertly in Deutsche Telekom's certified data centers. Depending on customer requirements, information is stored in regional data centers and processed in accordance with the data protection regulations applicable there – for example, GDPR-compliant in the EU and HIPAA-compliant in the USA. The system supports cross-regional collaboration, offers extremely reduced requirements for onsite Source Data Verification (SDV) and a comprehensive audit trail.
Features of the
TrialComplete EarlyPhase Edition
The subject database is used to collect and store both demographic data, comprehensive medical data and lifestyle data. This data is separated from the trial data but supports bidirectional flow of data to support a ‘single source of truth’. This allows the targeted search for trial subjects according to protocol specific inclusion and exclusion criteria. TCEP supports e-mailing information to potential participants and the sorting, categorisation and organization of interested candidates by status into probable cohorts. TCEP may be integrated with your participant recruitment website which makes it easier to accept new subjects into the database.
The automatic assignment of recruitment and participation statuses facilitates subject management and gives the team a comprehensive overview of the success, or otherwise, of recruitment efforts at all times.
Using the Remuneration Module, subject fees can be requested, approved, documented and paid out following a managed workflow.
The assessments required by the protocol for data collection in the pre-screening, screening, experimental and follow-up stages, are added into the workflow-based, study setup. Libraries are available for this purpose, which provide both standardized procedures (ECG, blood sampling, medication, etc.) and specially defined procedures (customized procedures). Libraries are site-specific, sponsor-specific or available globally.
Certain procedures, typically medication events are used to trigger the execution times of ‘downstream’ assessments, and staff are visually alerted what to do next, and when.
The events and assessments in the study setup may include pre-defined tolerance windows for their execution times, plausibility, validity, and completeness. Subjects, staff, medication, collection tubes, storage tubes etc. can utilize system generated barcode labels to help manage protocol compliance.
The immediate availability of all collected data enables prompt assessment, including internal quality control of all findings and remote monitoring.
To reduce the opportunity for error, and to increase reliability and speed in early-phase trials, we aim to integrate with as many medical devices and laboratory instruments or services as we can. Especially where the data types are complex, frequent and in large volumes. Ideally, medical equipment such as vital signs monitors, ECGs, weighing scales and laboratory instruments such as balances, etc. are integrated via the interface framework to ensure the seamless recording of measurement data in the database. Manual input is avoided as much as possible. The audit trial, which cannot be edited, monitors any corrections and registers every change.
The laboratory module supports electronic communication with internal or external safety laboratories and enables the automatic creation and management of laboratory orders as well as the secure, timely transfer and documentation of laboratory results, including review and electronic signature by the responsible study physician.
The workflows of the staff in the internal PK/PD sample processing laboratory are driven by the definition of sample paths that are verified at each step of the process by scanning the barcoded containers, in order to prevent pipetting and other sample processing errors and to ensure cold-chain compliance is observed and that there is complete transparency and detailed record keeping from ‘vein to freezer’ and beyond to the final shipment of the samples.
Our Services – Your Benefits
Automate trial processes and assure transparency, data integrity and compliance: TrialComplete EarlyPhase (TCEP).
Take a look at the benefits:
Collect trial data in real time, avoiding transcription and rework. TrialComplete EarlyPhase supports rapid participant recruitment, quick study setup and workflow-oriented process controls. Thanks to its highly flexible design, sites achieve fast and efficient delivery of both in-patient and out-patient trials with TrialComplete EarlyPhase.
To deliver a comprehensive eSource solution, TrialComplete EarlyPhase uses seamless integrations with medical devices and laboratory services. Medical devices such as vital signs monitors, ECGs, weighing scales and laboratory instruments such as balances, etc. can be connected via a flexible interface framework. The laboratory module supports electronic communication with internal or external safety laboratories and enables the automatic creation and management of laboratory orders as well as the secure, timely transfer and documentation of laboratory results, including review and electronic signature by the responsible study physician.
TrialComplete EarlyPhase stores and processes study data exclusively in Deutsche Telekom's data centers that are ISO/IEC 27001 certified and fully GDPR-compliant. In addition, the secure and expertly hosted system was developed in accordance with the GAMP 5 design approach and allows you to comply with 21 CFR Part 11 for the highest safety standards in clinical research.
The system, which was developed together with users with hands-on experience, and according to regulatory standards, is highly configurable and meets all requirements for GCP-compliant use. Thanks to its provision as SaaS (Software-as-a-Service) from the data centers of the Deutsche Telekom Cloud, trial management is independent of location and suited to multi-national cross-border organizations.
Is the system suitable for managing trials in multiple countries?
TrialComplete EarlyPhase supports any size of Early Phase operation, from single investigational sites to multi-country study networks. It includes features such as internationalization time and date formats and flexible site-based user rights administration, the system enables the conduct of clinical trials in different regions and time zones.
Can the system be interfaced with existing clinical systems (e.g. laboratory systems or medical devices)?
TrialComplete EarlyPhase offers a flexible interface framework that supports the integration of external systems such as laboratories or medical devices (vital signs monitors, ECGs, weighing scales and laboratory instruments such as balances, etc.). Some common devices are already interfaced. Connection with TCEP allows automatic data transfers and ensures secure data capture and processing. Interfacing with new systems or devices may require a separate engineering project and incur additional fees.
How does TrialComplete EarlyPhase ensure the security of study data and privacy of participant information?
TrialComplete EarlyPhase stores study data in certified data centers that are certified to ISO/IEC 27001 and are fully GDPR compliant. Pseudonymization of sensitive data protects participants while enabling compliance with EMA and FDA regulatory requirements for clinical trials. In addition, system was developed in accordance with the GAMP 5 design approach and allows you to comply with 21 CFR Part 11 for the highest safety standards in clinical research.
Can TCEP help me recruit trial participants?
TCEP allows you to contact your participant pool by e-mail, message services and even by letter, using ready-made merge templates. Medical and demographic data (from telephone and in-person interviews or participant recruitment websites) are continuously updated. The system supports the targeted search for suitable subjects for new studies and organizes them into study-specific cohorts. These features facilitate attendance management and significantly speed up the recruitment process.
How is study progress tracked in TrialComplete EarlyPhase?
TrialComplete EarlyPhase offers comprehensive reporting capabilities that can be used to monitor study progress in real time. Reports can be customized and exported in formats such as Excel or PDF, ensuring monitoring and quality assurance over the entire duration of the study.
What is the difference between TrialComplete EarlyPhase and TrialComplete LatePhase?
The TrialComplete EarlyPhase is specifically designed for early clinical trials (Phase I/IIa) and supports process control (automation) and subject management. The LatePhase Edition, on the other hand, is aimed at multisite, scientific / academic trials that process large medical image data sets. While the EarlyPhase Edition focuses on the rapid execution of EP studies and the integration of laboratory data, the LatePhase Edition enables seamless processing of image data in DICOM format.
What is the difference between TrialComplete and TrialSite?
TrialComplete focuses on the management and organization of the entire clinical trial and accompanies the process from planning to evaluation of the study data (clinical trial management). TrialSite, on the other hand, focuses on the management of the clinical trial sites themselves and optimizes administrative processes such as cost calculation and billing (clinical site management).