Software

Marvin seamlessly integrates EDC, DDE, CDM, CTM, IWRS, ePRO, Reporting and Safety-Notifications in one single application with a centralized database accessible from any web browser in any language. Marvin was one of the first two EDC software products certified by the CDISC organization for its compliance with the ODM standard. Marvin maximizes the advantages of an end-to-end application using CDISC XML standards and allows you to create an End-To-End mapping for your SDTM datasets utilizing tabulation.

Marvin contains numerous modules all delivered in a Software-as-a-Service model. Accessible from any browser, Marvin supports all global languages. The main benefit of Marvin: it is built utilizing the CDISC standard from the ground up and fully utilizes the related advantages.

We offer an integrated range of modules that cover the entire lifecycle and complete data management process of a clinical trial; the CDISC organization calls this the ‘end-to-end’ process. Thanks to the consistent use of various CDISC standards from CRF design to data collection, data cleaning and data export to tabulation, analysis and archiving, Marvin provides maximum benefit in the form of cost and time savings and improves quality by avoiding data conversion errors.


eye
  • Tailored to your needs
  • Your study online in record time
  • Software, as individual as your study
  • Development of new software features on customer request
  • Accessible from any browser and in any language
  • XML standard without programming knowledge
  • CDISC based automated End-to-End solution

Marvin :: features overview

xclinical-marvin-login

EDC

The main benefit of Marvin compared to other EDC products is the fact that it is built on the CDISC standard from the ground up and fully utilizes the advantages this offers throughout the Clinical Data Management process. Marvin was one of the first two EDC software products to be officially CDISC-certified for the ODM standard.

Key features ::

  • Multi-language eCRFs (incl. Russian, Japanese, Chinese …)
  • Source Data Verification (SDV) including Risk-based Monitoring
  • Data review including central adjudication
  • Advanced query management
  • (S)AE Notifications
  • Electronic Signatures
  • Documentation of concomitant medication
  • Clickable images and scales
  • Integration/upload of any type of binary data (Images, X-rays, etc. )
  • Handling of central and local lab data
  • Reports and Dashboards
  • Electronic archiving in PDF and XML format
  • Fine-grained access control
  • Complete Audit Trail
  • Quick implementation of study amendments
  • Out of the box standardized ODM database
  • Inbound and outbound web services API for integration with external systems
  • Extensive import capabilities for transferring studies from legacy systems into Marvin

composer

Composer (eCRF Design)

The XClinical Composer provides an intuitive graphical user interface for study setup including eCRF design and the generation of relevant documents (e.g. data validation plan). As a replacement for MS Word and Excel during the preparation of a clinical trial, the Composer generates considerable time and cost savings.

Key features ::

  • Intuitive graphical interface for quick and easy study setup
  • Smart search & copy functionality to create and use a library
  • Rule and formula editor enables the easy and unambiguous definition of a comprehensive data validation plan without the necessity of programming knowledge
  • Automatic output of the annotated CRF, visit matrix and data validation plan
  • Easy setup and management of amendments
  • Validated, CDISC ODM-compliant storage and export of the CRF design
  • Can be used in combination with any EDC system
  • Operates offline (MS Window, Linux, MacOS) and online (any browser)

iwrs-randomization

IWRS Randomization

The Randomization System is an IWRS (Interactive Web Response System) built into Marvin; therefore no interface to another external system is required. The system supports open or double-blind, multi-strata, multi-group randomization based on a block list or a widely configurable range of algorithms like variance minimization. The block-based randomization can be set up by uploading the configuration files via the web interface. The randomization list can include blocks of any size linked to an unlimited number of therapy groups and stratification parameters. The parameters for the configurable algorithms within the Marvin randomization system are configured using the Composer. For every patient entered in the study and fulfilling all necessary criteria, Marvin calculates the therapy group assignment.

logistics

Logistics

Included in the Randomzation System is also a materials accountability module with (investigational) medical product stock management inventory and logistics. Shipments of materials from a central stock to different sites is managed via a web-based workflow including optional package verification numbers. Shipments can be generated automatically or manually. Then Marvin assigns investigational products to patients according to their (blinded) therapy group.

Key features ::

  • Optional package verification number
  • Automatic shipment creation based on stock minimums
  • Batch shipping of IMP
  • Material expiry date control
  • Easy drug supplier integration into study workflow

ctms

Marvin for patients (WebPRO)

Patient Reported Outcomes (PRO) are increasingly important for all types of studies. Marvin includes a fully integrated WebPRO module, called “Marvin for patients”. Marvin WebPRO runs on any web browser in any language and supports all internet connected devices. Moreover, Marvin has been integrated with various wearable devices.

Key features ::

  • Simplified user interface
  • Clickable images and scales
  • Subject account management by site staff
  • Reminder and notification emails
  • Separate storage of patient identifying data in compliance with data privacy legislation
  • Inline reports
  • Role-based visibility of patient data
  • Simplified question labels
  • Integration of data from wearable devices

risk-based-monitoring

Risk based monitoring

The Marvin EDC system supports the source data verification (SDV) process by distinguishing different risk levels for each specific study center. Customized verification rules are defined in a detailed Monitoring Plan containing different risk levels. It makes the system adaptable to the site and data handling workflow. The Monitoring Plan may also be changed and amended at any time to ensure a maximum of flexibility in a fast-changing clinical study environment. The Monitoring Plan, combined with the Sponsor‘s identification of critical data and with a close control of entered data by automated plausibility checks is an effective and cost efficient way to guarantee the safety of subjects and the quality and integrity of clinical trial data.

Key features ::

  • Flexible definition of risk levels
  • Rules to define which parts of the CRF need to be verified for which patients
  • Additional flags to document customized data review
  • SDV to do lists provide guidance for CRAs
  • SDV reports

cdisc

SDTM Tabulation

The Composer supports end-to-end tabulation and allows the consistent and seamless use of a unique set of XML-based metadata from CRF design to data submission. It is an ETL solution (Extraction-Transformation-Loading), that leverages the CDISC define.xml standard and enables data managers to create CDISC SDTM-compliant datasets that are ready for reporting, analysis and submission inside the EDC database. Moreover, the Composer also supports custom tabulations such as sponsor-specific data set formats. Mapping instructions include rules for data derivations and data conversions.

Key features ::

  • Creation of define.xml
  • Mapping of CRF datasets and SDTM datasets
  • Copy & paste of value-level metadata between CRF and SDTM datasets
  • Easy setup of SUPPQUAL domains
  • Creation of SDTM-annotated CRFs
  • Intuitive graphical user interface
  • Independent from SAS or any other statistical software

marvin-for-paper

Marvin for paper: Double Data Entry (DDE)

Marvin supports double data entry both for paper and hybrid studies (combining paper and eCRFs). Marvin for paper implements two independent Data Entry steps and subsequent verification of discrepancies in a tabular overview. Every DDE field provides additional text and comment fields to capture all information from the paper form (e.g. data not matching the correct datatype). Data queries are triggered after the verification step.

Key features ::

  • Blind DDE: two different users enter data from paper in electronic form independent of each other
  • Dedicated review process: a third person starts a verification process in which the system identifies the discrepancies between both versions and presents them to the user to be resolved. The user interface provides an easy way to select the correct entries
  • Each item allows predefined formats as well as free text entries and a comment field for more information about the item value
  • Automated selection of matching forms, batch verification
  • Attachable ‘memos’ for internal notes and workflow support
  • Automated and manual query workflow including query printing
  • Full DDE audit trail and data export
  • Hybrid DDE/EDC mode by patient, by site or by page

ctms

CTMS – Clinical Trial Management System

Marvin provides a CTMS module that includes a set of customizable administrative forms to collect study management data. Such data is collected and processed in the same way as in the Marvin eCRFs, providing the same mechanisms of data review, reporting and communication as in the EDC system. The XClinical CTMS is not an out-of-the-box application but is always customized according to your individual requirements. This mechanism makes the system very agile because CTMS pages and reports may be changed at any time without losing data, just like a mid-study amendment in an eCRF.

Key features ::

  • User and site administration
  • General study information
  • Study team management
  • Site initiation and closure
  • Site monitoring visits and monitoring reports
  • Site contract management and financial information
  • Site logistics (e.g. shipping of materials and documents)
  • Management of approval by ethics committees or institutional review boards
  • Management of approval by regulatory authorities
  • Subject insurance management
  • Audits and quality management visits

coder

Coder

XClinical’s Coder module is a web-based tool to classify health-related data such as adverse events. It includes coding algorithms based on standard MedDRA dictionaries to auto-encode and manually encode verbatim terms and to generate predefined and customs reports. The Coder provides an interface for seamless integration with EDC systems such as Marvin via a web service API, eliminating the export/import efforts for data managers. The Coder includes a sponsor approval workflow and can transfer coding-related queries back to the EDC system.

Key features ::

    • Powerful search engine on all MedDRA dictionary levels (LLT/PT, HLT, HLGT, SOC)
    • Automatic and manual coding including sponsor- or study specific set-ups
    • Seamless web-based integration with EDC systems
    • Automation of export/import procedures using triggers or a scheduler
    • Automated transfer of coding related queries to an EDC system
    • Stand-alone web application – can be used independently of any EDC system
    • 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 that works on mainstream internet browsers
    • Management of MedDRA dictionary version upgrades, also other languages than English if requested

WHO-Drug coding is coming soon

Reporter

Marvin provides a set of real-time reports. Additional customized reports and dashboards can be added by qualified data managers.

Key features ::

  • Wide range of Standard Reports that can be activated
  • Filterable Listing Reports
  • Optional drilldown functionality
  • Graphical dashbords
  • Embedded links to the eCRF
  • Report data can be exported in various formats (csv, pdf, xls, doc etc.)