Services – TriaNXT

Our Product And Services

AI-Driven Intelligence: Our CTMS uses advance AI to detect errors, flag risks, and ask smart questions—ensuring accuracy and compliance at every step.
End-to-End Trial Management: From study setup to close-out, manage all trial operations in one unified platform.
Real-Time Insights: Get instant dashboards and analytics for faster decision-making and proactive risk management.
Automated Workflows: Reduce manual tasks with automation for scheduling, monitoring, and reporting, saving time and resources.
Regulatory-Ready: Built to comply with ICH-GCP, FDA, EMA standards—your data is always audit-ready.
Decentralized Trial Support: Enable remote monitoring, virtual visits, and patient-centric processes for modern trials.
Intelligent Data Entry: AI-powered tools ensure accurate CRF population and automated QC checks, speeding database lock.
Scalable for All Studies: Whether single-site or global multi-study, TriaNXT adapts to your needs effortlessly.

Accurate Data Entry & QC: Ensure precision with automated quality checks and validation processes.
ICF, Source Data & ISF Review: Conduct thorough reviews of informed consent forms, source documents, and site binders for compliance.
Quality Assurance: Implement rigorous QC checks for data accuracy and protocol adherence.
Regulatory Compliance: Ensure all site activities meet global regulatory standards (ICH-GCP, FDA, EMA).
Documentation Management: Streamline essential documents like ICFs, CRFs, and logs with digital workflows.
Remote Monitoring Support: Enable remote monitoring and virtual visits for modern, flexible site operations.
Visit Scheduling & Coordination: Automate visit planning to reduce delays and improve patient experience.

Study Planning & Setup: Comprehensive planning for smooth trial initiation and execution.
Protocol Compliance: Ensure strict adherence to study protocols and regulatory standards.
Site Selection & Activation: Identify, qualify, and activate high-performing sites efficiently.
Investigator & Site Training: Provide robust training for investigators and site staff to ensure quality.
Patient Recruitment Oversight: Monitor and optimize enrollment strategies for timely recruitment.
Monitoring & Oversight: Conduct on-site and remote monitoring for data integrity and compliance.
Risk-Based Monitoring: Leverage AI-driven insights for proactive risk identification and mitigation.
Vendor & Stakeholder Management
Coordinate seamlessly with vendors, sponsors, and stakeholders.
Quality Control & Assurance: Implement rigorous QC processes for accurate data and protocol adherence.
Real-Time Reporting & Insights: Deliver dashboards and analytics for informed decision-making and faster trial progress.

Protocol Development: Expertly crafted study protocols aligned with regulatory and scientific standards.
Informed Consent Forms (ICFs): Clear, patient-friendly consent documents ensuring compliance and understanding.
Clinical Study Reports (CSRs): Comprehensive and regulatory-ready reports for submission and audits.
Case Report Forms (CRFs): Accurate and structured CRFs designed for efficient data capture.
Subject Diaries: Patient-friendly diaries for reliable data collection and engagement.
Peer-Reviewed Publications: High-quality manuscripts for leading journals to showcase your research.
Abstracts & Posters: Impactful scientific abstracts and visually appealing posters for conferences.
Slide Decks & Presentations: Professional presentations for investigator meetings, conferences, and sponsors.
Conference Coverage: Complete support for scientific events, including reporting and documentation.

Objective Oversight: Unbiased monitoring to ensure data integrity and protocol compliance.
Risk-Based Monitoring: AI-driven risk assessment for proactive issue detection and resolution.
On-Site & Remote Monitoring: Flexible monitoring options for centralized and Remote.
Source Data Verification: Thorough review of source documents for accuracy and completeness.
Regulatory Compliance Checks: Ensure adherence to ICH-GCP, FDA, EMA, and local regulations.
Audit Readiness: Prepare sites and sponsors for inspections with detailed compliance reviews.
Corrective & Preventive Actions: Identify gaps and implement CAPA plans for continuous improvement.
Investigator & Site Training: Provide training based on audit findings to strengthen compliance.
Real-Time Reporting: Instant dashboards and reports for transparency and quick decision-making.
Independent Quality Assurance: Third-party audits for unbiased evaluation of trial processes and documentation.

Global Regulatory Expertise: End-to-end support for submissions across FDA, EMA, and other global authorities.
Dossier Preparation: Comprehensive and compliant CTD/eCTD dossier development for smooth approvals.
IND, NDA, ANDA, BLA Support: Expert handling of all major regulatory applications for clinical and commercial phases.
Ethics Committee Submissions: Timely and accurate submissions to IRBs/ECs for study approvals.
Regulatory Strategy Development: Tailored strategies to meet timelines and minimize approval risks.
Document QC & Compliance; Rigorous quality checks to ensure adherence to ICH-GCP and regional guidelines.
Lifecycle Management: Manage amendments, renewals, and post-approval changes seamlessly.
Real-Time Tracking: Monitor submission status and regulatory queries with instant dashboards.
Audit-Ready Documentation: Ensure all submissions are inspection-ready for global compliance.

Drive innovation and accelerate your clinical journey with TriaNXT’s AI-powered solutions.