TrialMaster

TrialMaster is an Electronic Data Capture (EDC) suite developed by Anju, designed to support Phase I–IV clinical trials and medical device companies. It targets site researchers, patients, and sponsor staff who need a flexible, device-agnostic platform for managing clinical study data from collection through submission.

The platform aims to reduce operational costs and improve data quality by shortening study build times, minimizing data entry errors, and accelerating study submission. It supports both traditional and decentralized trial models, including virtual and hybrid trial designs.

Access and Usability

• Accessible from any device — desktop, laptop, tablet, or smartphone — with screens that adapt in real-time to device size.
• Built-in ePRO allows patients to self-report outcomes directly within the same system used by site and sponsor staff.
• Single sign-on (SSO) support lets sponsors use their own identity provider (IdP) for authentication, reducing the need to manage multiple credentials.
• Users receive guided prompts and immediate feedback during data entry, including character-level validation, to reduce errors and lower training time and cost.

Study Build and CRF Design

• The TrialBuilder module provides a WYSIWYG CRF design interface for building simple or complex studies.
• Automatic edit check generation and parameterized edit checks are included to accelerate study configuration.
• CRF components and configurations can be reused across trials, reducing design time and operational costs.
• Studies can be built in a fraction of the time compared to other EDC solutions, according to the product description.

Data Quality and Query Management

• Flexible query management tools support data review and resolution workflows.
• Sophisticated reporting and data visualization provide actionable insights for trial oversight across a clinical organization.
• Real-time insights support regulatory compliance and quality management.

Risk-Based Quality Management (RBQM)

• Supports capture of risks and development of mitigation strategies based on Key Risk Indicators (KRIs).
• Risks are linked to KRIs and dashboards, monitored at both subject and site level.
• Mitigation strategies can be mapped to alerts and KRIs to maintain traceability.
• When integrated with Anju's RBQM Master application, users can access portfolio views across compounds or therapeutic areas, site performance profiles combining clinical and operational data, and subject profiles covering visit information, safety data, medical history, vitals, imaging, core labs, and investigational product exposure.

Source Data Verification (SDV) and Monitoring

• Flexible SDV allows patients to be randomized to a specific monitoring level, with randomization balance controlled by a site risk rating.
• The assigned monitoring level determines which forms require SDV, generating a task list for monitors.
• Monitoring levels can be manually overridden to apply a higher or lower SDV level for individual patients.

Serious Adverse Event Reporting

• The Safety Link feature allows site staff to enter serious adverse events, medical history, concomitant medications, dosing, and lab test information from existing patient data and transmit it to a safety system.
• An E2B file is generated and can be integrated with the sponsor's own safety system via Anju's adaptive clinical platform.
• Reduces reconciliation needs between the EDC and safety systems and eliminates duplicate data entry for site staff.

Central Lab Support

• Lab data, including images, can be uploaded directly to TrialMaster.
• Reference ranges can be defined in TrialBuilder for each lab test, with controlling variables such as patient sex, age, and visit date.
• When lab values are entered, the system automatically looks up the appropriate range, flags values as low, high, or normal, and prompts for clinical significance assessment when values fall outside the normal range.

Medical Dictionary Coding

• The AutoEncoder module supports coding against MedDRA and WHODrug Global dictionaries.
• Features include auto-coding, manual coding, review, and approval workflows.
• AutoEncoder can be integrated with TrialMaster or with external EDC or safety systems.

eConsent for Virtual and Hybrid Trials

• The eConsent process can be completed directly within the EDC system from any location using the mobile-enabled platform.
• Patients can enter their own data, create and launch video testimonials and documents from within an iCRF, complete assessments to gauge understanding, and provide an eSignature.
• No separate eConsent platform is required.

Data Export and Standards Compliance

• A drag-and-drop Custom Data Export Utility allows users to define export data domains and map collected data for statistical analysis, including SAS datasets.
• Supports mapping to industry standards including CDISC and SDTM, with standard templates available by default for all SDTM domains.

Multi-Language Support

• TrialMaster can be translated into any number of languages.
• Users select their preferred language and the corresponding text is retrieved from a global translations database and displayed immediately.
• Multiple users working in different languages can access the same trial simultaneously.

TrialMaster integrates with Anju's broader adaptive eClinical platform, including RBQM Master and other Anju solutions, as well as third-party systems via robust APIs and export capabilities. Related Anju products include CTMS Master for clinical trial management and TA Scan for clinical intelligence.