Overview

Superior usability and flexibility ...  TrialMaster is the EDC solution for Phase I - IV clinical trials.

With the most intuitive end-user experience, the most productive study design tool, flexible reporting, off-the-shelf integrations and convenient mechanisms for importing and exporting data, the TrialMaster Electronic Data Capture (EDC) Suite offers a compelling solution for EDC. 

Above and beyond typical EDC functions, the TrialMaster Suite can perform many tasks that were historically seen in clinical applications external to an EDC system. Bringing these modules into the TrialMaster Suite adds a depth of functionality that offers unique business benefits to our customers including: improved efficiency and communication across multiple business units, faster study completion, and a reduction in costly integration projects, which amount to significant cost savings across a clinical organization.

“As we continue to expand our geographic reach and services, at TFS we are always working to add value and enhance our services to our customers. We …. ensure … our customers a highly flexible EDC platform that is cost effective and extremely user-friendly. We believe our customers will really benefit from this new system’s functionality and full 24/7 real-time transparency.” Thea Wesseling, Executive Vice President, Global Clinical Development, TFS

EDC

Electronic Data Capture Functionality Outline

Setup and Administration

  • Set up of roles, users and sites
  • Assignment of users to sites
  • Creation of patients
  • Entry of lab reference ranges

Interfaces and Integrations

  • Import of external data
  • Generation of safety cases in E2B format
  • Coding of medical terms against MedDRA and WHO Drug
  • Read and write access to study data via web service APIs

Data Entry and Management

  • Entry of patient data
  • Real-time execution of edit checks and derivations
  • Management of system-generated and manual queries
  • Checking of lab data against reference ranges
  • Generation of internal and email notifications on events such as SAEs
  • Monitoring, locking & electronic signature of  iCRFs

Reporting and Exports

  • Execution of standard reports
  • Development and execution of adhoc reports
  • Generation of data exports, in SAS or CSV format
  • Generation of SDTM exports
  • Production of site archives, including FDA submission format

Features of the TrialMaster Electronic Data Capture Suite

Designed to be ‘Site-Friendly’

  • Extremely intuitive
  • Requires minimal training
  • Role based access to relevant information
  • Task driven workflow
  • Simplified tree-like navigation

Performance

  • No plug-ins (browser-based)
  • Speed & reliability
  • 128-bit SSL encryption

Benchmark for Study Build Time

  • Logical drag and drop trial building
  • Library of re-usable forms
  • Programmerless edit check design
  • Interface with e-Protocol systems

Maximum Design Flexibility

  • User-friendly GUI
  • Add custom specific modules
  • Multiple patient/subject types
  • All screens considered “CRFs”
  • Customization Style Sheets
  • Javascript Forms Customization
  • Auto/Manual Form Rendering

Microsoft .NET Standard Middleware

  • Microsoft .NET architecture
  • Ease of integration
  • Superior data import/export functions
  • Support for web service calls
  • Simple to implement Mid study changes
  • Encoded SSL Connection

ePRO

Patient Data Entry

It is well-proven that Patient Reported Outcomes are more accurate and reliable when recorded electronically rather than on paper. However, the solutions have historically required a separate mobile application that is costly and time-consuming to administer. Not any more. Now it is possible for patients to enter their data directly into EDC, providing a simple unified environment and immediate data access for sponsor and site personnel.

During study design, the forms for use by patients are built alongside the other forms in the trial. Edit checks are programmed to test data validity, and to set the expected time windows for data entry. For example, a patient diary form could be configured to accept data between 6pm and midnight for every day between “Visit 2” and “Visit 3”.

A patient may then be registered to TrialMaster by the site coordinator. The details of that user registration are blinded to all sponsor personnel. The patient gets email notifications whenever data is expected, then clicks on a link in that email and enters the required password to log on. The patient is then presented with the forms expected in that time window, enters the data through simple web dialogs, and is logged off automatically when the last form is completed. At this point the data is immediately available in TrialMaster and appears automatically in the data exports.

In summary, TrialMaster provides the benefits of contemporaneous patient data, without the headache and expense of a separate ePRO system.

Coding

The TrialMaster Auto-encoder

The Autoencoder solution allows companies to manage and classify free text terms captured during the clinical drug development process. Autoencoder acts as a global, central repository for managing these verbatims and corresponding dictionaries of terms. Leveraging global thesauri contained in standardized dictionaries. Autoencoder facilitates the classification of verbatim terms using a variety of automated tools and functions contained within Autoencoder:

  • The Autoencoder allows any fields to be coded from any dictionary automatically.  Standard commercial dictionaries are supported:
    • MedDRA
    • WHODrug
  • Non-standard client dictionaries can also be defined and used.
  • Multiple versions and views of the dictionaries can be created.
  • Dictionaries are mapped to the eCRF pages at the item level.  Fields can be mapped as:
    • Mapped – this is the single field used as the lookup to the dictionary
    • Displayed – these fields are displayed on the coding screen and saved to the database
    • Not Displayed – these fields are not displayed on the coding screen but are still saved to the database.
  • The Autoencoder can restrict the amount of data to be processed by filtering at site, subject, event and page
  • Autocoding is submitted as a batch job to allow other work to proceed.
  • The Autoencoder tries to match the mapped field to the dictionary as follows:
    • Exact match
    • Modified string match – here extra spaces and illegal characters are removed
  • If no records are returned the same process is used against a history, or thesaurus table.
  • Once the coding job is complete the Coding Review screen can be reviewed which shows the results of the auto-encoding, and allows manual coding to be performed
  • The review screen can be filtered to show specific results :
    • All
    • Uncoded
    • Proposed
    • Reviewed
    • Approved
    • Applied
  • A manual code lookup can be performed for Uncoded and Proposed status.
  • The status of the coding can then be marked as Reviewed then Approved (these are role based privileges)
  • The coding can optionally be saved to the history table – particularly for uncoded records following a manual coding.
  • The codings can then be updated to the database.  This is submitted as a job to allow other work to proceed.  Once completed the clinical database will be updated with the selected dictionary records.
  • The Autoencoder is fully integrated with TrialMaster EDC to allow for the automated and manual coding of adverse events and concomitant medications captured within EDC.

SAE Handling

SAE Reporting through SafetyLink

When a patient in a clinical study experiences a Serious Adverse Event, there is nothing more frustrating for the site than to be asked to re-supply information that is already in the EDC system. Providing the event details again, the patient demographics, the lab results and a potentially long list of concomitant medications represents unnecessary and duplicative work. TrialMaster solves this problem by providing mechanisms to detect an SAE and transmit the data to the clinical safety team in the industry-standard E2B format, obviating the need for site personnel to re-enter the data.  This digital transmission covers the event(s) in the safety case, plus all related information, and the case may be versioned over time as the source data changes.

 

safetylink

The SAE information is automatically selected based on a mapping from the source data that is specified during study design. No programming is required. Furthermore, this means that future study designs may reuse the same mapping, which significantly reduces the setup time. This mapping reuse does a “best fit” analysis between the source study and the target study. For example, if the original study collected AE start time but the new study doesn’t, the mapping to the E2B start time element is nulled out in the new study. The designer may either leave this null value in place, or inspect a “variables not mapped” report and remap the variable to a different item in the study.

Reporting

Self Service BI Application for Business Users

Logi Ad Hoc is a self-service business intelligence application that empowers business users to create and share their own dashboards, reports, and analysis without involving IT. Easily accessed from any web-browser, Logi Ad Hoc is used today by thousands of non-technical users.

LogiXML_Ad_Hoc

Short Learning Curve

Logi Ad Hoc has been designed from the ground-up to allow everyday business users to create reports without IT involvement. The application comes pre-loaded with a highly intuitive user interface for report creation and enables easy report sharing to a wide audience of consumers.

  • Step-by-step process to quickly guide users through building dashboards, reports and analysis
  • Interface packed with guidance, allowing business users to quickly increase productivity with minimal training and support

Sophisticated Capabilities

Logi Ad Hoc enables business users to easily design impressive dashboards, reports, and analyses, leveraging powerful yet easy-to-use features such as:

  • Crosstabs, drill-down and drill-through reporting
  • Conditional styling, user-defined columns, math and statistical calculations
  • Dashboards with up to four columns
  • Interactive Data View (IDV) enables data to be filtered on the fly to perform quick calculations or create “what-if” scenarios
  • Multiple export options
  • A wide variety of static and animated charts and graphs
  • Scheduler to automatically deliver reports at various intervals

Rapid Deployment and Easy Administration

Other business intelligence deployments can take months before you’re able to run your first report. With Logi Ad Hoc you can be up and running in just a few hours with no coding and minimal initial IT resources, enabling business user self-sufficiency going forward.

  • Rapid database connection and setup wizards
  • Metadata database for transparent storage and protection
  • Web-based Admin Console makes ongoing maintenance quick and painless

Integration Ready

LogiXML utilizes standards-based technologies such as XML and CSS to support integration requirements such as white label rebranding.

  • Include your own logo, color scheme, and images
  • Supports integration with most security models to achieve single sign-on, or to fit within an established security infrastructure
  • Role-based authorization and access restrictions to data objects at the object or column level

Multi-Platform

Supports data from popular SQL-compliant sources in .NET and Java environment

Multi-Language Support

TrialMaster supports any number of languages, single and multi-byte. That means you can build a trial once, translate the metadata into the desired languages, and allow users to pick the language of their choice. All form names, visit names, item prompts, codelist entries and edit check messages will appear in that language. The TrialMaster application itself may be similarly translated, so all menus, prompts, button labels and messages appear in the chosen language.

Download Multi-language  Solution Brief

TM_multi_lingual

 

The ability to select which additional languages are available for any given trial introduces a translation overhead that can equally be mitigated by innovative product capabilities. To that end OmniComm provides integration to automated translation services so once a study design team have built a new trial in their language of choice, they can initiate an automated translation of both product/interface and eCRF languages to the additional languages they need to support on that trial

The clinical data itself is effectively language-agnostic, since numbers and dates are universal while coded fields contain an internal value rather than a language-dependent label. Only free text fields may need manual translation. This means, for example, that a trial may be conducted in English, Spanish, French and Japanese, but be analyzed in English.

 

Trial Design

For Designing and Building EDC Trials with TrialMaster

TrialMaster offers a rich and versatile toolset for designing and building a trial. The toolset consists of TrialBuilder for building the trial and TrialExplorer for configuring and deploying the trial. Both are desktop tools that run under Microsoft Windows®, thereby providing a highly-productive and responsive environment, complete with a multi-window user interface and drag-and-drop functionality.

Overview of the Trial Design Process using the TrialMaster EDC Solution

  • Create a new trial, or import the definitions from a prior trial or global library
  • Build the codelists, items, item groups and forms to implement the eCRFs in the trial
  • Build one or more visit schedules, and map the forms to their appropriate visits
  • Develop the edit checks, derivations and dynamic form behaviors
  • Generate default data export definitions (by form and/or by item group)
  • (Optional) Define custom data exports, including Study Data Tabulation Method (SDTM) domains
  • (Optional) Define the format of files to be imported
  • (Optional) Define lab tests with units and conversion formulae
  • (Optional) Set up mappings of data elements to MedDRA and WHO-Drug for coding
  • (Optional) Set up randomization scheme
  • Deploy the trial to a UAT environment for testing
  • Deploy the trial to a production environment

Modeling the eCRFs

TrialBuilder provides an elegant navigator for the elements in the trial. Objects are displayed in a tree view with standard expand/collapse icons. The process of modeling a new trial would typically start with defining the code lists, followed by the items, the groups, the forms and the visits. Items may be reused across groups. For example, an item “Med start date” could be placed in both a concomitant medications and a prior medications group. Similarly, the same group may be reused across forms, with properties such as the maximum number of allowed rows, which are potentially different on each form. Finally, each form is associated with the visits which may occur, with the maximum number of form occurrences specified as a property.

Right-clicking on any object provides a menu of allowable operations, such as Edit, Copy, and Delete.  The Edit option shows a dialog for managing the object’s properties, which may include its name, datatype, control type, codelist, SAS name, SAS format and SAS label.

Groups are built by dragging the requisite items into them. Items may be re-sequenced by dragging them up and down in the group. The same mechanism is used to add groups to a form and to add forms to a visit. This user interface is more productive and intuitive than picking items from a list.


eCRF Layouts

Once the forms are defined from their component groups, it is possible to review and modify the default data entry layout for that form within TrialBuilder. The layout can be modified by editing the generated HTML, such as placing fields side by side (e.g., to enter blood pressure as ___  / ___ ), or rendering pain scale background images to guide the data entry process. This custom layout will be identical in TrialBuilder, in the EDC screens, and in the blank and completed PDF casebooks.

Edit Checks

Edit checks encompass range checks on a single item, comparisons between items on the same or different forms, and complex logic such as randomization algorithms. Edit checks are written in JavaScript, which is the standard programming language for adding interactive behavior to an HTML web page. For most cases, the JavaScript programming is minimal. For example, to check that an AE start date is before the stop date, drag the start date item into the expression window, type “<=”, then drag the stop date item into the window. This asserts that the data is valid if the start date is less than or equal to the stop date.

Edit checks may be defined at any level of the hierarchy. The example above is defined with the “DM01” group because the logic is the same regardless of where the group is used. However, if the check is sensitive to the visit information, such as checking that that visit occurred within an allowed time window, then the edit check would be defined within the appropriate visit.

Other available edit actions are:

Item / Group Properties

Derivations

Object Creation

Other

Set hidden/displayed

Set item value

Create visit

Give warning on save

Set enabled/disabled

Set item row value (prefill)

Create form

Send notification

Set enterable/read only

Set form caption

Include form in add list

Set form status

Set required/optional

 

 

 

Enforce unique value

Exports and SDTM

Submission-Ready Data in Less Time

Click Here to Download the Solution Brief

The data captured in a data management system, whether via Electronic Data Capture, or external system imports (e.g. ePRO, labs etc.), once cleaned and monitored, will ultimately be exported to datasets for analysis and/or submission. Statisticians and programmers devote a large amount of time and effort to map and transform clinical data from a data model optimized for data entry, cleaning and monitoring the domains required for data analysis and reporting.

The TrialMaster Custom Data Export Utility is a drag-and-drop tool allowing you to define export data domains, map and transform the data collection data model to the export domains, and map to industry standards such as CDISC SDTM. Your exports are configured using the fully integrated validated mapping utility for repeatable exports. Mapping can be performed once the data collection model is defined, and before the final data is collected. Once data is locked, your exports are ready to run immediately. Providing efficiencies at the data export definition provides the end users with timely exports of the data. The exports can be run on a schedule by the system, or the TrialMaster end users can select the exports to run on demand.

EDC_Custom_Export_Utility

Key Features

Key Benefits

The TrialMaster Custom Data Export Utility is fully integrated into the standard TrialMaster Suite of eClinical software for ASCII, SAS and CDISC SDTM exports.

Additional tools are not required to build or run the clinical data exports. Updates to the export utility and standards are included with TrialMaster updates.

Data can be exported on demand by the end user, or by scheduling tasks to run on the server at a predetermined time and frequency.

Scheduling data exports ensures that the system performance is not compromised, and that data is available when it is required by the user on network drives, ftp/sftp sites etc.

Standard and custom data exports are created as part of TrialMaster's validated environment, and can be reused on additional studies.

All data exports, including custom templates are validated and repeatable for data listings, SAS extracts, subject profiles, CDISC SDTM exports for submission, etc.

Standard templates are available for all SDTM domains and can be created by default by the mapping utility, and included in the SDTM define.XML file.

Adding the SDTM domains by default, reduces the time required for definition and validation. Early definition of the exports allows for less lag time at the end of the study.

Data can be exported in standard ASCII, and SAS. CDISC SDTM format data is available for the study, site, patient, visit, form, group, item and codelists, in addition to the clinical data, and data management information.

Standard analyses tools can be used to import and view and import the data. Data can be displayed in Excel, or in SAS or as an SDTM export including the define.XML file.

 

Automating the Production of SDTM Datasets - Webinar

 


SDTM in Real Time Case Study - Webinar

Trial Configuration

For Configuring and Deploying EDC Trials with TrialMaster

Both tools are desktop based and run under Microsoft Windows®, thereby providing a highly-productive and responsive environment, complete with a multi-window user interface and drag-and-drop functionality.

Trial Configuration

clip_image002_0000Trials are configured and managed by an authorized administrator using a tool called TrialExplorer. This is a Windows product that provides a convenient navigator interface for viewing and managing all the trials in the system. An example screenshot is shown to the right.

Trials are created either by copying from an existing trial, or by importing a trial definition in XML format. This XML file will have been generated via an export from TrialExplorer on the same server or a different server. In this manner, trial definitions may be effortlessly moved between environments – typically from Development to QA to UAT to Production. TrialExplorer keeps track of the different versions of the trial definition over time.

TrialExplorer supports the following operations:

  • Trial import and export
  • Trial creation, copying and deleting
  • Trial versioning
  • User security for trial design
  • Setting of trial configuration parameters, such as password expiration time
  • Configuration of directories for TrialMaster data imports and exports
  • Mid-Study Changes

A mid-study change is handled as follows. The designer creates a new version of the trial in TrialBuilder. If change is to be deployed in a different environment – e.g., moving from Development to QA – then the trial design is exported from the source environment and imported into a new version of the trial in the target environment. The administrator then launches the mid-study change dialog and selects one or more sites to be migrated from the old version to the new version.

A sophisticated difference engine detects and processes all modifications between the source and target versions. This includes adding new items to existing forms, changing item properties (such as from enterable to read-only), handling codelist changes, and re-executing all changed edit checks and derivations. The mid-study change may be executed on a running system – there is no need for planned downtime. Once the mid-study change is complete, users will see the appropriate changes in TrialMaster. For example, if a new item has been added to a form, those iCRFs will be reverted to an “incomplete” status so that the site user knows to re-visit those forms and enter the additional information.

APIs

Connecting Data Across the e-Clinical Spectrum

OmniConnect is TrialMaster's web services API that enables clinical research organizations to quickly and cost-effectively integrate their existing e-Clinical systems to create a best-in-class e-Clinical research enterprise.

OmniConnect conforms to the REST (Representational State Transfer) style architecture. The OmniConnect API is based on an extended CDISC ODM (Operational Data Model) dataset and allows for the exchange of clinical data seamlessly and in real-time between the TrialMaster Electronic Data Capture Suite and other eClinical solutions.

The use of REST web services in the API is the first of its kind in the industry. OmniConnect brings together complex clinical trial management functionality with our TrialMaster EDC solution in a single, integrated database. By receiving a consistent stream of data, TrialMaster enables sponsors and sites to take advantage of real-time integration of disparate information and data sources.

OmniConnect can be used to interface to IVR/IWR randomization and patient management systems to pass the patient enrollment information to TrialMaster, while passing the drug administration information back to the drug supply management system providing a real-time interface.

OmniConnect can be used to interface to ePRO systems to provide a centralized data repository for all patient data, including patient reported outcomes, and other clinical data for a study. The ePRO data can be transferred to the TrialMaster EDC database in real-time or on a schedule.

OmniConnect can be used to provide the clinical data from the TrialMaster EDC database to study management systems and central global portals and reporting systems to deliver an in-stream, holistic view of study status to sponsors and CROs.

 Key Features

 Key Benefits

Use of REST (Representational State Transfer) Web Services based on an extended CDISC ODM (Operational Data Model) dataset

State of the art technology, and follows OmniComm’s continued focus on interoperability and standards to provide value based solutions.

32 REST services are available for exchange of eClinical data as an interface to external systems. The TrialMaster OmniConnect Web Services may be used by external systems to push data to the TrialMaster EDC database via HTTP PUT or for data retrieval from external systems via HTTP GET.

The available services maybe used for various tasks for integrating systems to the central TrialMaster Electronic Data Capture Suite. These include transferring data for patient enrollment, visit information, ePRO (patient reported outcomes), drug administration etc.

The TrialMaster API system architecture is service based supporting asynchronous operations. The process manager is responsible for orchestrating the completion of each request.

The TrialMaster OmniConnect web services provide real-time exchange of clinical data, making the data sent or retrieved available immediately for processing

The REST service facilitates access to the data provided in an ODM format.

Using industry standard protocols for data exchange

Secure access  is provided by the API URL using a defined user name, password and trial group

Access to the clinical data is secure and provided from a validated study environment.

Data is available for the study, site, patient, visit, form, group, item and codelists, in addition to the clinical data, and data management information.

Both meta-data and clinical data can be exchanged using the OmniConnect API. This information can include clinical data points, query statuses, etc.

Using the TrialMaster OmniConnect API, the study structure meta data can be extracted.

Using a single REST request, the entire study can be extracted to a CDISC ODM file.

eLearning

eLearning

TrialMaster EDC eLearning delivers a robust, role-specific, self-paced, web-based education tool to all site users of the TrialMaster Electronic Data Capture application.  TrialMaster EDC eLearning provides a comprehensive, secure interactive tool that leverages rich media content, audio coaching, instructional feedback and interactive assessments to deliver role-based tutorials and testing to all TrialMaster EDC site users.

Benefits of our e-Learning solution include:

  • Flexible Learning Approach – TrialMaster users can learn at their own pace and at their own convenience, instead of being required to “attend” a scheduled training session.
  • Quality – Self-paced training technology ensures that a consistent, reliable message is delivered to all users and certifies that application skill and proficiency is achieved rapidly by having the student pass a user assessment test.
  • Compliance – e-Learning software will maintain a record of successfully completed training and ensure that only trained coordinators, investigators, etc. are enabled to access the TrialMaster application.
  • Innovation – As an EDC technology leader OmniComm customers expect to see training and support techniques that leverage innovative technology and industry leading practices.

TrialMaster eLearning Key Components and Features

  • The Learning Management Portal – The eLearning portal is delivered as an extra tab on the TrialMaster home page.  The portal provides users with the capability to launch the training lessons, take a user assessment test, track the usage of eLearning and maintain records of the training completion and assessment results.  At the customer’s option, the portal ensures that users cannot enter or modify data without having successfully completed the eLearning assessment tests.

Electronic Data Capture eLearning
 

  • TrialMaster eLearning Lessons – TrialMaster eLearning lessons present users with an interactive, web-based sampling of our application. The eLearning modules utilize technology that delivers intuitive learning through a point-and-click interface, a scripted audio dialogue and interactive features such as rollover sidelets, zoom objects, highlights and grayouts, rollover images, text animations, simulations and other rich media content.

Electronic Data Capture eLearning Lessons 

  • The Student Assessment – Upon completion of each module (a group of lessons), students are required to take a short on-line assessment, to certify that they have sufficiently learned the materials.   Interactive elements such as dynamic testing, question pools, instructional feedback and instant scoring are utilized.  At the customer’s discretion, users will not be allowed to access TrialMaster unless they have successfully completed the student assessment.

Electronic Data Capture Course Assessment 

TrialMaster eLearning Project Scope and Timeline

TrialMaster eLearning is tightly integrated into the TrialMaster end-user portal, to reduce overhead, ensure compliance, and provide the best overall end-user experience.