Download the Ultimate Clinical Trial Tracking Checklist
Our Commitment to Quality:
Tl’s seamlessly connected eClinical platform adheres to global regulations. Our platform architecture and capabilities helps life sciences organizations stay compliant and improve overall quality.
21 CFR Part 11
TI’s 21 CFR Part 11 compliant eClinical platform provides assurances for audit trail functionality, electronic signatures, security and data integrity, record retention, etc.
ISO 9001:2015
TI’s QMS complies with the ISO 9001:2015 international standard and is audited in accordance to enhance customer satisfaction. View the certificate here.
SSAE 16 SOC 2 Type 2
All data centers comply with this standard for reporting on controls at service organizations.
Annex 11
TI’s eClinical solutions comply with Annex 11 standards for computerized systems, ensuring data integrity, security, and traceability.
GDPR
Our platform adheres to GDPR requirements, safeguarding personal data with robust privacy and security measures.
Privacy Shield
TI complies with Privacy Shield principles to ensure secure and compliant data transfers between the US and the EU.
HIPAA
TI’s policies and procedures are designed to comply with this standard and employees are required to pass introductory training.
HiTrust
TI meets HiTrust’s rigorous standards for safeguarding sensitive health information. View the certificate here.
GAMP 5
Our computerized systems are GAMP 5 compliant and are evaluated based on the framework’s risk-based approach.
Our Quality Capabilities
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SSAE 16 SOC 2 Certified
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Intrusion Detection
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24 x 7 Monitoring
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Horizontally Scalable
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Data Processor
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Data Encrypted at Rest
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Fully Redundant with Uptime SLA of 99.97%
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BCP: RTO: 24 hrs.; RPO: 1 hr.
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Monitoring: Nagios, Grafana, ELK, Zabbix and Pingdom
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GxP, 21 CFR Part 11, Annex 11 Compliant
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IaaS Configuration Logs (AWS Cloud Trail and Guard Duty)
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IaaS Deployment Logs (AWS Cloud Formation)
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Infrastructure Qualification / System Tests
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Record Audit Logs
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AWS Global Data Centers (N. Virginia, Oregon, Frankfurt, Dublin, Ningxia, Beijing)