- An online web-based interface without client installation or client data storage.
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- An electronic data capture feature to collect, view and review CRF data in an ICH GCP-compliant manner, including capture of binary data (images/documents).
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- Audit trail and electronic signatures compliant with FDA 21 CFR part 11, and a contemporaneous and independent investigator copy being created each time a CRF is saved.
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- A configurable role-based permission system.
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- Country, site group, and site scoping of study subjects and personnel.
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- Data review, lock and query features, as well as selective SDV.
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- Extensive support for configurable automated data management (optionality, missing values, range checks, and edit checks).
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- Support for configurable calculated values (close to unlimited in algorithm complexity level).
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- Support for configurable responsive/interactive visibility conditions on a level of role, study schedule, or data dependency.
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- A metrics and reports interface to get an overview of the study.
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- A feature for entering and applying laboratory reference values with both time, location, and factor scope.
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- A data export feature that allows output of all or subsets of data to Excel, CSV, SAS, PDF/A (compliant to FDA submission format as laid out by eCTD), and CDISC ODM formats, as well as online chart visualization, and blank/annotated CRF output.
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- An API that allows for both import and export of data in CDISC ODM format to allow for integration with other systems, as well as a stand-alone command line application that takes CSV files and a define.xml compliant mapping (feature to create this mapping is available) to allow for import to the API to cover the basic cases of data import.
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- A randomization and allocation feature that offers the choice to assign values from a pre-computed static list or a dynamically generated/randomized list.
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- A trial supply management system for monitoring and handling investigational products.
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- An electronic trial master file feature to capture manage, share, and store essential documents during the clinical trial. Viedoc eTMF is based on the TMF Reference Model by the Drug Information Association (DIA).
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- A medical coding feature that supports MedDRA, WHODrug (with major version 4 being certified by UMC), ATC classification system, and Iyakuhinmei Data File (IDF).
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- An email alert feature to make key personnel aware of data events.
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- An integrated and configurable electronic Patient Reported Outcomes feature (ePRO) according to the BYOD model, including email and SMS reminders.
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- An integrated telemedicine solution that enables Clinic staff to initiate video calls with subjects.
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- An integrated telemedicine solution that enables Clinic staff to initiate video calls with subjects.
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- A configuration interface that allows for complete independence in terms of study configuration and enables reuse of study building blocks (and for Viedoc version 4 and up: WYSIWYG editor, comprehensive version management, transportability/import/export and off-line examination/revision of the configuration in CDISC ODM XML format).
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- Support for simultaneously running unlimited versions of a study configuration (Viedoc version 4 and up only).
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- An administrative interface to facilitate study maintenance and helpdesk tasks, as well as manual data import and possibility of study recreation from a previous snapshot.
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- A study-level database lock feature, and a unique and fully self-service study decommissioning feature, including status reports and archiving recommendations.
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- User authentication and data security measures that, at any point in time, are up-to-date with industry standards.
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- Online documentation/eLearning for both end users, managers, and administrators.
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- Multi-tenant hosting in one of the regions Europe, Japan, China, or the US with strict data isolation, encryption-in-transit and encryption-at-rest.
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- A service level agreement (SLA) that details service availability, data continuity, and security.
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- Maintenance and operation of the major version in which an individual study is set up throughout the study license term.
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- Continuous updates and improvements but with backwards compatibility with all versions within the same major version.
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- Respect to applicable industry standards in terms of development practices, system validation, and IT operations.
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- Regulatory compliance with clinical trial regulations according to EMA, FDA, JPMA, and CFDA.
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- Regulatory compliance with the Personal Data Protection laws including GDPR (EU), APPI (Japan), HIPAA (US), and the PIPL (China).
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