Regulatory Alignment
Complies with FDA 21 CFR Part 11, EMA Annex 11, GDPR, HIPAA, and ISO 27001, ensuring your processes meet global pharmacovigilance standards.
Transparent Audit Trails
Maintain accountability with detailed audit trails that log all user actions, enhancing transparency and trust in your workflows.
MedDRA Integration
Standardize adverse event classification with seamless MedDRA integration, ensuring consistency and precision in pharmacovigilance workflows.
Connected to Global Standards
Compliance built into every workflow.
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Smarter Decisions
Backed by Data
TrialTrak delivers real-time dashboards and customizable reports that keep teams informed and aligned across every stage of drug safety workflows.
Its predictive insights shaped through customer collaboration help uncover trends that support stronger decisions across safety, efficacy, and R&D.
By connecting post-marketing data with strategic priorities, TrialTrak helps teams act faster and more confidently.
From Start to Finish
Effortless Workflows
TrialTrak simplifies the pharmacovigilance journey with digitized protocol approvals and structured study workflows. It reduces manual effort and improves operational efficiency by aligning teams on a centralized platform.
Built-in tools for study scheduling and task tracking ensure that every milestone is met with clarity and consistency keeping timelines intact and compliance on track.
Regulatory Alignment
Stay compliant. Stay inspection-ready.
TrialTrak is built to help your organisation confidently meet the highest global pharmacovigilance requirements. It ensures end-to-end data integrity, robust audit trails, and industry-grade security, empowering you to manage drug safety processes efficiently and stay ahead at all times.
With advanced security controls, complete and accurate audit records, and workflows designed to simplify compliance, TrialTrak helps streamline pharmacovigilance operations while protecting sensitive data across every touchpoint.
Transparent Audit Trails
Compliance and confidence on one unified platform.
TrialTrak logs every user action to create comprehensive audit trails that support accountability and inspection readiness. This built-in transparency ensures every decision and update is traceable.
Maintain tamper-proof audit records
Automatically capture every system and user action to ensure a complete, unalterable record.
Support internal reviews and inspections
Provide regulators and internal teams with easy access to well-organized, verifiable audit trails.
Enhance visibility and accountability
Track activity across workflows to improve oversight, reduce risk, and ensure operational discipline.
Strengthen trust across teams and stakeholders
Reinforce confidence with a transparent system that supports collaborative, compliant operations.
MedDRA Integration
Structure. Speed. Precision, built into your safety workflows.
TrialTrak integrates seamlessly with MedDRA, enabling standardised adverse event classification across all pharmacovigilance workflows. It supports automated coding that ensures accuracy, consistency, and regulatory alignment. This streamlines case processing and improves the overall quality of safety data.
With automated MedDRA updates and built-in validation, TrialTrak strengthens data precision while reducing manual errors and ensuring reporting remains reliable and compliant.
WHO Drug Dictionary Integration
Precision-driven medication mapping made easy.
TrialTrak’s integration with the WHO Drug Dictionary (WHO DD) powers fast, automated drug coding across all safety workflows. It improves the accuracy of medication reporting, reduces manual effort, and accelerates case processing for regulatory submissions.
By aligning medication data with trusted WHO DD standards, TrialTrak ensures global compliance while enhancing the reliability and efficiency of your pharmacovigilance reporting.
Effortless Scalability, Unwavering Support
Designed to grow with your needs, TrialTrak supports secure, compliant scale-up across global studies.
Centralized Admin Console
A unified platform to manage user roles, study configurations, and workflow permissions. This enables consistency, control, and simplified oversight across teams and geographies.
Enterprise-Grade Data Security
TrialTrak protects sensitive clinical and safety data with robust encryption, secure storage infrastructure, and periodic vulnerability assessments aligned with global security protocols.
2–4 Week Provisioning
TrialTrak is designed for speed and efficiency, allowing new studies to go live within 2–4 weeks. The setup process is structured to reduce delays and get teams operational faster.
Dedicated Support
Our enablement team supports every step of implementation, ensuring smooth configuration, quick user adoption, and confidence from day one.
Stay Informed and connected
Experience seamless smart, automated notifications and responses with TrialTrak.
TrialTrak ensures timely communication with its Notification Manager, delivering automated reminders and alerts via SMS, Email, and App Push notifications.
Notification Manager:
The Auto-Reply Engine streamlines updates, providing instant, accurate responses to alerts, keeping all stakeholders aligned and informed.
Auto-Reply Engine:
Seamless
Stakeholder Engagement
TrialTrak accelerates onboarding for investigators and participants while ensuring every stakeholder stays informed with smart, automated communication tools.
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Swift Onboarding
Simplify and accelerate enrollment for Principal Investigators (PIs) and participants.
Real-Time Enrollment
Ensure accurate and efficient tracking of subject registrations as they happen.
Smart Notifications
Keep everyone aligned with automated reminders sent via SMS, Email, and App Push notifications.
Instant Responses
Address alerts promptly with an Auto-Reply Engine delivering real-time updates.
Turn Data into Decisions, Instantly.
Stay informed with real-time updates and actionable insights that drive smarter decisions.
TrialTrak delivers real-time updates and customizable dashboards that keep you informed at every stage of your workflow. Providing instant access to study progress, safety signals, and adverse events empowers teams to make precise, data-driven decisions and maintain complete operational control.
Outcomes That
Drive Impact.
Adverse Event Management
with Speed and Accuracy
TrialTrak simplifies adverse event management by eliminating manual workflows and reducing operational errors. Automated processes enable faster reporting and precise signal identification, helping teams respond efficiently and maintain regulatory compliance.
Future of Pharmacovigilance Today.
TrialTrak brings automation, compliance, and data-driven clarity to every step of your pharmacovigilance journey.
Get Started Today
Discover how TrialTrak’s advanced features empower you to streamline workflows, ensure compliance, and redefine drug safety management.