PHARMACOVIGILANCE

Monitor your project within a robust safety system and ensure consistent communication with safety experts. BCG medical experts work with your team to create a well-designed safety management plan (SMP) and provide prompt and precise support for dealing with adverse event/ reaction information for your investigational and marketed drug products. We can provide a wide range of services: Case Processing & Reporting, Literature Screening, Periodic Reporting, Pharmacovigilance Consultation.

Staff with expertise from the pharmaceutical industry

• Our staff has case processing expertise and come with various healthcare backgrounds such as physicians, nurses and pharmacists.

Ability to provide service to meet the customer needs

• We can flexibly provide wide range of PV support services in conventional pharmacovigilance activity and comprehensive PV operation.

SAFETY MANAGEMENT PLAN

• SMP creation and coordination
• Outline study safety activities and processes
• Define roles, responsibilities, workflow, templates, and actions for safety management

SAFETY DATABASE

• Create a safety database apart from the clinical trial database
• Reconcile safety data with clinical adverse event data
• Create and maintain safety database based on study-specific protocol
• In conjunction with client’s Data Management team

Case processing AND SAFETY REPORTING

• Define overall procedures for the collection, evaluation, and reporting of SAEs
• Receipt and triage of initial and follow-up cases
• Data entry, MedDRA coding, Creating a Narrative
• Receive specific details on SAE flow in a safety management plan
• Process each SAE, evaluate for medical accuracy, and enter into the safety database
• SAEs coded in compliance with CRF coding
• Pre-assessment (unexpectedness, regulatory reportability)