With the dramatic increase in approved medical products, maintaining vigilance over the corresponding growth in medical literature is taxing regulatory teams.
Reduce burden on your team with an efficient and compliant workflow solution designed to zero in on the most critical, pressing information when you need it.
Enable your pharmacovigilance experts to keep focus on what matters most – patient safety – by using tools and a process that simplifies the repetitive and tedious literature review. Transparently measure the productivity, quality and timeliness of the work performed by your multiple teams. Be confident that your operation is under control, inspection ready, and compliant.
Clarivate offers an unrivalled post-marketing end-to-end medical literature monitoring solution for Individual Case Safety Reporting (ICSR), creation of Aggregate Reports, such as PSUR, PBRER, DSUR, and detection of Potential Signals.
The modular solution includes:
“With Drug Safety Triager we just completed an EMA audit; we have zero findings from the literature review process.”
“Compared to what we had before, Drug Safety Triager is like going from a horse-drawn carriage to a space rocket.”
“Off-X curates publicly available data from multiple sources into a user-friendly dashboard that allows the user to access relevant information quickly for safety evaluation. Analysis that usually took hours to complete could be completed in minutes with Off-X. ”