Clinical Safety Services
We provide clinical safety services for medicinal products and medical devices. Our expertise covers a range of therapeutic areas and product classes, including small molecules, biologicals, ATMPs and gene therapies. As an external full-service clinical safety unit, we offer clinical trials Sponsors and CROs the flexibility, scalability and operational efficiency.
We have years of experience in developing robust Safety Management Plans and offer a systematic approach to clinical safety management. Our team provides high quality and accurate case processing, timely expedited and aggregate reporting. 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 and handle data migration from any third party vendors to a single database.
Development of Safety Management Plans
Regulatory Intelligence on Country-Specific Reporting Requirements
Provision of EudraVigilance (EV) Responsible Person
Processing of SAEs and other Reportable Events
Medical review, assessment and MedDRA coding
Regulatory Reporting (EudraVigilance, US FDA, local authorities)
Preparation and submission of periodic safety reports