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.

Services Offered:

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)

Narrative writing

Preparation and submission of periodic safety reports

Safety Management Plans (SMPs) written
SUSAR and periodic reporting compliance
24/7 safety and medical monitoring

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Apr 26, 2021

Clinical Safety Management Plan and its Importance

The Safety Management Plan (SMP) is one of the most important documents…

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Apr 19, 2022

Centralizing Safety Data Management

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

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Jul 21, 2021

Integration of Client-Vendor Pharmacovigilance Systems

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