Software

Manage the lifecycle of a clinical study from eCRF setup to data sets ready for submission with Marvin, XClinical’s all-in-one, user-friendly eClinical software. Marvin helps CROs, biopharmaceutical and medical device corporations accelerate study setup and execution, save time, and improve data quality.

Marvin is an integrated solution comprised of various eClinical modules, all of which combine to optimally support clinical trial processes and enable seamless data flow. These modules include study build software, EDC, IWRS (randomization) and drug management, WebPRO, coding, SDTM tabulation, risk-based monitoring, reporting, and clinical trial management.

Marvin brings together these functionalities into a single application with a centralized database that is accessible from any web browser in any language. By doing this, the solution simplifies and speeds up the entire data management process. Marvin is built from the ground up on CDISC standards. This ensures that clinical data seamlessly flows through the Marvin platform, improves data analysis across clinical trial databases, and optimizes data exchange with external systems.

All these powerful functionalities can be quickly and easily configured without programming knowledge. Marvin streamlines the process of delivering vital medications and devices to market while ensuring the highest standards in data security.


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  • 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

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
  • Advanced query management
  • (S)AE Notifications
  • Electronic Signatures
  • Clickable images and scales
  • 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 service APIs for integration with external systems
  • Extensive import capabilities for transferring studies from legacy systems into Marvin

Composer (eCRF Design)

Never again struggle with the pain of turning to a mix of MS Word, Excel, and Powerpoint docs into a folder to try to customize your study startup. With XClinical’s Composer, you can produce eCRF designs, document links, and more to live in a single intuitive interface for your team.

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 (Drug Management)

Included in the Randomization 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

SDTM Reviewer

SDTM Reviewer

The SDTM Reviewer is an interactive tool for a fast, efficient review of your SDTM datasets created by Composer Tabulation. It may be accessed via any modern browser and will not impact the performance of any of your studies. The result of utilizing the many pre-configured, fully integrated reports is a much faster, in-depth analysis of your data than from any other comparable product on the market.

Additionally the SDTM Reviewer can be used as a stand-alone solution.

Key features ::

  • Provides a user-friendly graphical SDTM Data review tool
  • Interactive filtering on multiple parameters
  • Pre-defined, integrated reports
  • Dramatically increases the value of doing SDTM mapping before study start
  • Web-based, data visualization solution based on R Shiny, Apache and Linux
  • Software-as-a-Service business model

Reporter

Marvin provides standard reports, custom reports, dashboards and interactive ad-hoc reports.

Classic features ::

  • Real-time data
  • Built-in security (users only see data for which they are authorized)
  • Automatic linking of reports to the eCRF to accelerate your daily routine and decision making
  • Patient profiles and other multi-page report formats

New features ::

  • Automated data filtering according to user’s permissions and investigative site affiliation
  • Extended access to queries, eCRF status and audit trail information
  • Select data from any page and any visit with a simple mouse click
  • Choose between bar charts, pie charts, scatter plots and any other type of reports
  • Add filtering, sorting and grouping
  • Publish your reports for colleagues in any format (excel, pdf., powerpoint or interactive html tables)

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.
  • Automated selection of matching forms, batch verification
  • Attachable ‘memos’ for internal notes and workflow support
  • Automated and manual query workflow including query printing
  • Hybrid DDE/EDC mode by patient, by site or by page

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 2

XClinical’s Coder modules are web-based tools to classify safety-related data such as adverse events or concomitant medications. They include standard MedDRA and WHODrug dictionaries to automatically and manually encode verbatim terms by use of powerful search mechanisms. The coder modules are fully integrated in Marvin via a Web Service API. Hence it is even possible to utilize them in other solutions (or EDC Systems). Its key advantage is eliminating any import/export processes for data managers. Coded information can be transferred back to the EDC system to allow reporting and queries.

Key features ::

  • Web-based system, working on all modern standard browsers
  • Powerful search engine on all MedDRA dictionary levels (LLT, PT, HLT, HLGT, SOC)
  • Versatile search engine for all elements of WHODrug like indication, dosage, ATC
  • UMC-certified support for WHODrug B3 and C3 standards
  • Automatic and manual coding including sponsor- or study specific set-ups
  • Stand-alone web application – can be used independently of any EDC system
  • Online participation of sponsor staff for review of difficult cases and validation
  • Full audit trail documentation
  • XML import and export
  • Project-based coding (multiple studies can use the same coding instance)

 

elearning

eLearning

XClinical offers new online interactive training system. With the end user in mind, eLearning incorporates the tell/show/do training methodology.

Marvin for Sites

  • Marvin for Sites is an eLearning module especially created for the site’s personnel (e.g., study nurse), who need a basic understanding and knowledge of the operation and functionalities of Marvin EDC.

Marvin for Sites with WebPRO

  • Marvin for Sites with WebPRO is based on the module Marvin for Sites. It has additional content about the Marvin WebPRO functionality.

Marvin for Monitors

  • Marvin for Monitors is an eLearning module especially created for monitors, who’s work will be supported by a basic understanding and knowledge of the validation functionalities of Marvin EDC.

All eLearning sessions can be followed by a certification quiz and printed document for end-users.