Safety Data Management

We provide high quality and accurate safety data processing and timely expedited and aggregate reporting services. Our team has extensive experience in case management, including case intake, data entry, coding, medical review, follow up, and quality control. We have hands-on experience with most safety databases, such as Veeva Safety Vault, Argus, ArisG, and others. We can help you set up the database, host it for you if needed, and handle safety data migration from any third-party vendors to a single database.

Our experience covers both clinical trial safety data management as well as post-approval ADRs management. We can handle submissions of expedited reports (ICSR, SUSAR) or periodic aggregate reports (PSUR, DSUR). And we can submit them to central systems, such as the EudraVigilance, as well as to country-level authorities where such is required. Our comprehensive PV regulatory intelligence oversight guarantees that our clients stay a step ahead of any changes in regulations and reporting requirements.