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.

 

Services Offered:

E2B and CFR21 compliant validated Safety Database

Processing and reporting of Individual Case Safety Reports (ICSRs)

Processing of SAEs and other Reportable Events from clinical trials

Medical review and medical assessment

Medical Coding (MedDRA, WHODrug)

Narrative writing

Preparation and submission of Periodic Safety Update Reports (PSURs)

Preparation and submission of Development Safety Update Reports (DSUR)

Regulatory Reporting (EudraVigilance, US FDA, local authorities)

0%
ICSR reporting compliance
0+
Data Migration projects handled
0+
Countries monitored weekly for changes in regulatory reporting requirements

Read more

Apr 19, 2022

Centralizing Safety Data Management

Clinical Trial Sponsors usually select full-service CROs to handle all aspects of…

Read more

May 11, 2022

Managing Pharmacovigilance Data Migration

The successful pharmacovigilance safety data migration requires a strategic and structured approach….

Read more

Jul 21, 2021

Integration of Client-Vendor Pharmacovigilance Systems

Pharmacovigilance (PV) activities are fundamental to both patient safety and regulatory compliance,…