Secure Safety Reporting
We have advanced our solutions to make in-trial and out-of-trial interview safety reporting easy, secure and ICH-GCP compliant. Working closely with sponsors, we ensure patient safety and privacy, while minimizing clinical burden.
Ensuring patient safety and ICH-GCP compliance
Our years of experience as a market-leader in in-trial interviews enables us to provide expert guidance to minimize patient, clinical, and sponsor burden while ensuring consistently high quality safety reporting worldwide.
Our approach to safety reporting rests on these pillars:
Robust safety reporting framework
When potential adverse events are detected, our robust reporting framework (CLINIGMA® Portal and PV process) ensures patient safety while minimizing clinical burden:
Streamlined PV reporting in accordance with sponsor
Interviewers document potential adverse events in real time
Clinical sites receive immediate notifications
Real-time patient follow-up by the clinic, as required
Expert interview process
We ensure every patient interview is conducted in accordance with the highest ethical and safety standards, supported by extensive training and meticulous planning:
ICH-GCP training
General and project-specific pharmacovigilance (PV) training
Experienced qualitative researchers (postgraduate or PhD in anthropology, sociology, psychology, or similar field)
Comprehensive interview manuals, instructions and training
Our advanced CLINIGMA® Portal technology
The CLINIGMA® Portal is the heart of our easy pharmacovigilance reporting processes. This unique interview solution enables:
Real-time notification of potential adverse events to clinical sites
Automated reminders to meet critical reporting timelines
Comprehensive documentation for data integrity and compliance
Private and precise data capture of sensitive information
Why the CLINIGMA® approach makes a difference
Our comprehensive safety reporting system delivers:
Timely identification and
documentation of adverse events
Strict adherence to regulatory reporting requirements
Seamless communication between CLINIGMA® staff and clinical sites
Consistently excellent safety reporting procedures globally
Complete and accurate safety data for sponsors
Protected patient privacy through secure systems
Simplify your safety reporting
Our PV manager would be happy to discuss your specific needs and answer any questions you might have.
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