The Assign Group provides complete pharmacovigilance services. At the center of our pharmacovigilance process is patient safety and regulatory compliance. Patient safety narratives are written with input provided by the Assign cross-functional teams, who are reviewing all available data and information (e.g., pharmacovigilance database, clinical trial database, CIOMS forms, hospital records, case report forms).

Pharmacovigilance services:

• Review of Clinical Study Protocol
• Set-up of DSMB, DSMB reports
• Set-up and maintenance of safety database
• SAE handling manuals , Medical review of SAEs and follow-up , Medical assessment of causality and expectedness
• Expedited reports (SUSARs) to CAs and ECs/Investigators
• SAE tracking and update of SAE documentation , Coding (MedDRA, WHO-DD, ATC)
• Generation of CIOMS-I forms and line listings
• SAE reconciliation
• Periodic Safety Reports (PSURs)