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Electronic Data Capture

ec-edc


Through XClinical’s EDC solution ‘MARVIN’ Trialforce leverages all of the essential eClinical technologies such as Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), ePRO, medical coding and Interactive Voice and Web Response Systems (IVRS/IWRS) to improve efficiency, reduce costs and maintain data quality.

MARVIN’s main advantage is the utilization of CDISC standards from CRF design to data collection, data cleaning, data export to tabulation, analysis and archiving. This process creates maximum benefit in the form of cost and time savings, and improves quality by avoiding data conversion errors.

Key advantages include:

  • CDISC certified end-to-end process
  • Fully functioned 21 CRF part 11 EDC supports electronic, paper or hybrid studies
  • Integrated Patient Randomization system (IWRS) included
  • Customizable Clinical Trial Management (CTMS) functionality included
  • Medical Coding system included
  • Web-based ePRO system included (for patient questionnaires)
  • Third-party data import, including central Labs
  • SDTM dataset generation with built-in tabulator
  • Built in CDASH forms that facilitate fast Study deployment
  • Support for Risk Based Monitoring

Other features


The XClinical CTMS is a web application including a set of customizable administrative forms, workflows and reports that are completed and processed in the same way CRF forms are within the MARVIN EDC system. Therefore, the same mechanisms of data review, reporting and communication can be used as in MARVIN.

Data can be automatically extracted from different EDC systems into the MARVIN’s CTMS via the web service interface (SOAP protocol) or via data import procedures avoiding double entry of administrative information.

Monitoring reports can be automatically generated (also after data has been reviewed, approved and signed by a manager).

MARVIN’s CTMS is fully customized to exact individual requirements. Therefore, it may be considered as a “solution” instead of as a product. This mechanism is very much oriented towards the future because CTMS forms/pages/reports may be changed at any time in the future without losing data just like an e-CRF can be changed via a protocol amendment.

Key features include:

  • Randomization
  • Trial drugs logistics (stock and shipment management)
  • User, role and site management
  • Freely configurable administrative templates for supporting project management
        (e.g. monitoring reports, essential documents, etc.)

  • Simple document management
  • News and documentation page
  • Text messages
MARVIN offers an intuitive and easy-to-use IWR (Interactive Web Response) ePRO solution. Subjects may use any PC connected to the Internet to securely access the ePRO application.

Key features include:

  • Fully audit trailed patient data
  • Ability to monitor patient compliance
  • Simplified user interface and item descriptions for patients
  • Optional communication between investigator and subjects
Clinical Data Management tools are an integral part of MARVIN. By collecting and managing all data captured within the same system, we reduce risk and improve efficiency throughout a study.

Key features include:

  • Automated and manual query workflow (both for EDC and DDE, online and batch processing)
  • Metadata version management (protocol amendments)
  • Database access using SAS, SPSS or any SQL/ODBC- compatible tool
  • Import and export of metadata and data, e.g. laboratory data import
  • Data protection-compliant, separate storage of medical and identifying data
XClinical’s coding system INCA is a web-based tool to classify health-related data such as adverse events and medications. It includes coding algorithms based on standard dictionaries MedDRA and WHODRUG to auto-encode and manually code verbatim terms and to generate predefined and custom reports. INCA provides an architecture for seamless integration via web services (SOAP, XML), eliminating the export/import efforts for Data Managers. In summary, INCA provides substantial time and cost-savings.

Key features include:

  • Powerful search engine on all dictionary levels (LLT/PT, HLT, HLGT, SOC)
  • Automatic and manual coding including sponsor-specific thesaurus (synonym lists)
  • Seamless web-based integration with EDC systems eliminating export/import procedures
  • Online participation of sponsor staff for approval of difficult cases and validation
  • Pre-defined and customizable online reports of the study coding status
  • XML import and export
  • Full audit trail documentation
  • Web-based, multi-sponsor, multi-database
  • Works on mainstream internet browsers
  • Management of dictionary version upgrades
While the eClinical market focuses on technology solutions, there are several common scenarios for Double Data Entry (DDE) and especially hybrid studies where the tight integration that MARVIN provides between EDC and DDE offers notable advantages. MARVIN includes Double Data Entry capabilities, including free text entries, comments, review process, query and memo workflow, etc.

Key features include:

  • Concealed, double data entry and review of discrepancies
  • Audit trail
  • Automated verification of fault-free templates
  • Free text and investigator comments fields for each item
  • Attachable ‘memos’ for internal notes for each item
  • Checking of manual calculations
  • Printable queries and query lists
  • Hybrid usage of EDC and DDE is possible – even for a single patient (e.g. when a site switches from DDE to EDC).

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