Frequently Asked Questions
TrialMaster is an intuitive Electronic Data Capture (EDC) solution designed to streamline Phase I-IV clinical trials. Known for its superior usability and flexibility, it accelerates trial development, improves data quality, and reduces study submission times.
TrialMaster is compatible with all devices, including desktops, laptops, tablets, and smartphones. With responsive design capabilities and single sign-on (SSO) authentication, users can access the platform from anywhere without maintaining multiple login credentials.
Yes, TrialMaster dramatically shortens study build times with its TrialBuilder module. Features like WYSIWYG CRF design, parameterized edit checks, and the ability to reuse components across studies simplify and expedite study deployment.
TrialMaster seamlessly integrates with other tools in Anju’s eClinical platform and third-party solutions. This interoperability enhances data sharing, streamlines workflows, and improves trial efficiency.
Hosted on a secure cloud platform, TrialMaster employs industry-leading cybersecurity measures to protect clinical trial data. Access controls and audit trails ensure that only authorized users interact with sensitive data.
TrialMaster includes robust export capabilities for data transformation and mapping to industry standards such as CDISC SDTM. Users can generate SAS datasets for statistical analysis with ease using drag-and-drop tools.
TrialMaster enables seamless management of decentralized clinical trials by offering tools to handle complex trial workflows efficiently. Its robust features, such as built-in ePRO and eConsent, provide flexibility for hybrid and virtual trial designs, ensuring rapid scaling and execution.
TrialMaster ensures high data quality through flexible query management, immediate data validation feedback, and sophisticated reporting tools. Users receive actionable insights with real-time data visualization and analytics, enhancing trial oversight.
TrialMaster offers extensive customization options, including multi-language support, risk-based quality management tools, and integration with third-party systems through robust APIs. This ensures the platform adapts to the unique needs of any clinical trial.
- Ease of Use: Intuitive interface and guided prompts reduce training time.
- Improved Data Quality: Actionable insights with advanced analytics and query management.
- Faster Study Builds: Rapid study design with reusable components.
- Compliance: Supports 21 CFR Part 11 and GCP standards for regulatory adherence.
- Flexibility: Adapts to virtual, hybrid, and traditional trial designs.
Yes, TrialMaster simplifies SAE reporting by integrating with safety systems. It enables real-time E2B file creation and reduces duplicate data entry, streamlining safety management workflows.
CTMS Master is a comprehensive clinical trial management system (CTMS) designed to enhance the efficiency and accuracy of managing clinical trials of all phases and therapeutic areas, including medical device trials, and decentralized or hybrid trials. With advanced tools for site monitoring, document management, finance tracking, and compliance, CTMS Master stands out as one of the best CTMS solutions for clinical trials.
Key features include:
- Integrated Site Visit Report (SVR) Tools to simplify site monitoring.
- Quick Study Setup using reusable templates for budgets, documents, and events.
- Study Finance and Budget Management for tracking budgets, payments, and invoices.
- Protocol Deviation Management for regulatory compliance.
- Informed Consent Tracking to improve participant oversight.
- Support for TMF structures using CDISC Reference Models (V2.0, V3.0) or custom configurations.
CTMS Master offers extensive configuration to meet unique organizational needs:
Delivered preconfigured to industry standards, it allows for adjustments to over 400 configuration settings and 50 system tables (e.g., Contact Types, Document Types, Budget Vendor Types).
Users can also add custom fields to capture additional data.
Yes, CTMS Master is built for the challenges of decentralized clinical trials (DCTs) and virtual or hybrid studies. Its robust platform allows for seamless monitoring, reporting, and participant management across remote sites and centralized teams.
CTMS Master excels with:
- Integrated monitoring tools for efficient site visit management.
- Quick deployment using reusable templates for studies.
- Advanced finance management capabilities for payments and invoicing.
- A user-friendly platform designed for both small-scale and multinational trials.
CTMS Master transforms trial operations by:
- Automating workflows to reduce redundant tasks.
- Providing real-time project insights with 100+ metrics and customizable reports.
- Supporting remote site management for decentralized and virtual trials.
Yes, CTMS Master integrates with most EDC systems.
EDC integration: Enables automated data transfers (via API or export/import), updating subject information, enrollment status, protocol deviations, and payment approvals.
eTMF: Supports CDISC TMF Reference Models, automatically mapping documents to the TMF when uploaded. TMF-structured .zip files can also be downloaded for third-party sharing and archiving.
CTMS Master adheres to strict compliance standards, including:
- 21 CFR Part 11 for secure electronic records and signatures.
- HIPAA compliance for protecting patient data.
- Tools for audit trails and protocol deviation management to maintain accountability.
CTMS Master provides:
- Improved oversight through real-time analytics and actionable insights.
- Enhanced compliance with built-in regulatory support.
- Streamlined communication across stakeholders with centralized data.
- Reduced costs through automation and faster study setup.
- Scalability for multinational studies and complex trial designs.
Yes, the Finance module within CTMS Master provides comprehensive capabilities to track budgets at the trial and site level, define payment milestones, and track investigator payments.
