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 …)
  • Right-to-left data entry option
  • Integration of any type of binary data (Images, X-rays, etc. as CRF attachment)
  • Electronic Signatures
  • Source Data Verification (SDV) with Risk-based Monitoring
  • Documentation of concomitant medication
  • Clickable anatomic images
  • Online Reports
  • PDF printouts
  • Audit Trail
  • Compliance with all relevant regulatory requirements of the FDA and EMA, in particular 21 CFR Part 11
  • GCP system validation

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 amendments handling
  • Validated, CDISC ODM-compliant storage and export of the CRF design
  • Can be used in combination with any CDISC ODM-compliant EDC system
  • Operates offline (Microsoft Windows) and online (any modern browser)
  • Imports third-party vendor extensions without any modifications

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)

With continuously increasing requests requiring Patient Reported Outcome, Marvin provides a so-called WebPRO as an integrated module.

Key features ::

  • Integrated part of Marvin
  • Simplified user interface for optimal user acceptance
  • Configurable visibility of WebPRO data to other users such as the investigator
  • Simple account creation directly by site personnel
  • Inline reports
  • Email alerts
  • Date dependent visibility e.g. the user may enter data only during a certain period or to disallow modification of previously entered data
  • Clickable images and scales
  • Qualified identifying data handling compliant to EU legislation
  • Automatic password forgotten workflow
  • Language-specific simplified question labeling for patients

risk-based-monitoring

Risk based monitoring

The Marvin EDC system supports the source data verification (SDV) process by distinguishing between different levels of expected data validity for each specific study center. By setting up a detailed Monitoring Plan containing risk levels and customizable verification rules the system is ideally adaptable to the site and data handling workflow. This 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.

cdisc

CDISC Tabulation

Tabulation is an integral part of the Composer. It is an ETL solution (Extraction-Transformation-Loading), which works independently of databases because it is built on the CDISC define.xml standard. It enables users to create CDISC SDTM-compliant datasets ready for submission to the authorities or for reporting purposes. Data managers can define mapping instructions for converting CDISC ODM data into CDISC SDTM or other partially de-normalized datasets.

Key features ::

  • Define.xml-based mapping of EDC/CDM datasets and SDTM datasets
  • Intuitive graphical user interface
  • Copy & paste of value-level metadata between CRF and SDTM datasets
  • Easy setup of SUPPQUAL domains
  • Creates define.xml including links to the annotated CRF
  • Independent from SAS

marvin-for-paper

Marvin for paper: Double Data Entry (DDE)

Despite the fact that the majority of clinical data capture is performed electronically there is still a need for paper based data capture under specific circumstances. Typical examples are hybrid studies where the tight integration between EDC and DDE offers notable advantages. Marvin includes DDE capabilities, including free text entries, comments, review process, query and memo workflow, etc..

Key features ::

  • Blind DDE: two different users enter data from paper in electronic form independent of one another; neither can see what the other has entered or if there are any discrepancies
  • Dedicated review process: a third person starts a verification process in which the system identifies the differences between both versions and presents them to the user to be resolved
  • Each item allows predefined formats, free text, and investigator comments
  • Automated selection of matching forms, batch verification
  • Attachable ‘memos’ for internal notes and workflow support
  • Automated and manual query workflow including printing
  • Full DDE audit trail
  • Hybrid use of EDC and DDE is possible – even for a single patient (e.g. when a site switches from DDE to EDC)

ctms

CTMS – Clinical Trial Management System

Our CTMS is a special type of module including a set of customizable administrative forms, workflows, and reports that are completed and processed in the same way CRF forms are completed and processed within the Marvin EDC system. Therefore, the same mechanisms of data review, reporting and communication can be used as in Marvin.

Key features ::

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

coder

Coder

XClinical’s coding system (Coder) is a web-based tool to classify health-related data such as adverse events and medications. It includes coding algorithms based on standard MedDRA dictionaries to auto-encode and manually encode verbatim terms. The Coder provides an architecture for seamless integration with EDC systems. The Coder’s workflow enables sponsor approval processes as well as the transfer of coding related queries to the EDC system.

Key features ::

  • Powerful search engine on all dictionary levels (LLT/PT, HLT, HLGT, SOC)
  • Automatic and manual coding including sponsor-specific thesaurus (synonym lists)
  • Automated XML import / export procedures
  • Automated transfer of coding related queries to 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
  • Full audit trail documentation
  • Web-based, multi-sponsor, multi-database
  • Management of dictionary version upgrades