Safety/PV

Our experienced safety and pharmacovigilance team provides complete and customized services to pharmaceutical, biotechnology, and medical device companies to effectively track and manage the adverse events and benefits throughout the lifecycle of a product.

Our Expertise

Management
AE/SAE Management

Our safety team provides the full safety management services to identify, evaluate, minimize, and appropriately manage risks. Services include triage of the events, source documentation collection, causality assessment and submissions to regulatory agencies as appropriate.

safetyNarrative
Safety Narrative

Our safety team writes complete, relevant, and chronological accounts of a safety event in compliance with ethical and regulatory requirements.

caseReporting
Case Reporting

Our safety associates and managers evaluate each event carefully and the required safety reports are submitted to the IRBs, regulatory agencies, safety monitoring boards and sponsors in accordance with the protocol and regulatory requirements.

Cereblis enables companies to take advantage of innovation in tech by onboarding new ways to work and execute projects by advising, implementing, and optimizing digital solutions.

Clinical Services

Strategy Consulting
Project Management
Site Management
Electronic Trial Master File
Clinical Monitoring
Biostatistics
Data Management
Quality Management System
Safety/PV
Computer System Validation (CSV) Services

Digital Services

Digital Strategy
UI/UX Design
Salesforce
Sales Performance Management
Cloud Platform Services
Integration

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