Effortless Compliance
Regulatory Reporting Made Seamless
Ensuring drug safety requires accurate, timely, and standardized reporting across multiple regulatory frameworks. Manual processes can introduce errors, inefficiencies, and compliance risks, delaying approvals and increasing operational burdens.
TrialTrak automates pharmacovigilance reporting, integrates with global databases, and ensures full adherence to FDA, EMA, CDSCO, HIPAA, and ISO 27001 standards.
Quality management, simplified.
Ensuring drug quality requires stringent compliance, continuous risk monitoring, and streamlined documentation. Manual processes, disconnected systems, and delayed reporting create inefficiencies that slow down approvals and increase regulatory risks. Without real-time insights and automation, maintaining consistent quality becomes a challenge.
Detect Risks Early
Ensuring Safety, Enhancing Quality.
Automated Quality Monitoring
Digitize and standardize quality checks for consistency across trials and post-market studies. Automate documentation to reduce human errors and ensure compliance readiness.
Proactive Risk Identification
Use AI-driven analytics to detect quality deviations early and mitigate risks before they escalate. Improve response times with real-time alerts and predictive quality tracking.
Built-In Regulatory Compliance
Maintain adherence to FDA, EMA, GMP, and ISO 27001 requirements with automated compliance tools. Ensure effortless audit trails and seamless regulatory reporting.
Centralized Oversight for Quality Teams
Unify all quality control, risk tracking, and compliance data in one platform. Improve collaboration between quality teams, regulatory bodies, and manufacturers for faster resolutions.
Turn Safety Insights into Smarter Decisions
Pharmacovigilance data is more than just compliance—it’s an opportunity for cross-functional collaboration.
With AI-powered analytics and automated reporting, TrialTrak transforms safety data into strategic intelligence, empowering R&D, regulatory affairs, and medical affairs teams to optimize drug formulations, anticipate compliance risks, and improve patient engagement.
Accelerated Study &
Drug Safety Readiness
TrialTrak enables rapid study initiation and streamlined manufacturing approvals with 1-week provisioning, minimizing downtime and ensuring standardized quality checks. Its patient-centric adverse event reporting enhances real-world evidence collection, while real-time feedback loops help medical reviewers identify safety signals faster, improving overall drug safety and compliance.
Get Started
Smarter drug quality starts here. Discover how Turnkey Learning's innovative solutions can transform your operations and enhance efficiency.