Language Services for Pharmacovigilance & Safety Reporting

Translate SAEs and SUSARs from the investigative site’s or market’s native language, including rush and handwritten requests.

Rapidly receive/process cases and communicate potential safety concerns or findings to regulatory authorities through our safety reporting platform, Trial Interactive that is 21 CFR Part 11-compliant, as well as via our global call center that can handle over 170 languages. 

Quickly and securely collect, track, and share safety data from investigative sites with Safety Notification Letters for a full audit trail of activity.

Establish new call centers handling case intake and processing or supplement existing call center resources by handling overflow call volume in over 170 languages.

Construct a communication strategy to fit your patients’ ongoing needs. From selecting, testing, training, and onboarding expert multilingual staff to translating follow-up documentation to improve patient adherence and reduce recidivism, our services cover all of your needs.

21 CFR Part 11-compliant solutions for safety notification letter distribution and GVP-compliant PSMF management. Visit the Trial Interactive site. 

Safety-specific AI engines and human post-editors to reduce translation timelines by half. 

AI-powered PII redaction services for your documents—our technology and professional redaction specialists help to reduce time to redact by over 75%.

Real-time translation of voicemails, emails, adverse events (AEs), call notes, etc., to allow your team to route cases to the appropriate parties.

Automated monitoring of adverse events in local literature and consolidation of your data for review and analysis within one solution.

Expert writing services for standard response documents, safety notification letters, regulatory writing, and more.