Pharmacovigilance Consulting
Patient safety is our top priority in every clinical trial. Our global pharmacovigilance and device safety team consists of experienced scientists and healthcare professionals dedicated to providing exceptional safety support throughout all phases of drug development.
Regulatory Compliance
Global Regulatory Requirements: Ensuring compliance with international pharmacovigilance regulations, such as FDA, EMA, PMDA, and TGA.
Safety Data Management Systems: Implementing and validating safety data management systems.
Safety Reporting: Assisting with the preparation and submission of safety reports to regulatory authorities.
Regulatory Inspections: Preparing for and supporting regulatory inspections.
Risk Assessment and Management
Risk Identification and Assessment: Identifying and evaluating potential safety risks associated with drugs and medical devices.
Risk Minimization Plans: Developing and implementing risk minimization plans to mitigate safety risks.
Safety Signals: Identifying and investigating safety signals.
Safety Data Review and Analysis
Safety Data Review: Conducting regular reviews of safety data to identify trends and potential safety issues.
Safety Data Analysis: Using statistical methods to analyze safety data and identify safety signals.
Benefit-Risk Assessment: Evaluating the balance of benefits and risks associated with drugs and medical devices.
Safety Communications
Safety Communications Plans: Developing and implementing safety communications plans to inform healthcare professionals and patients about safety risks.
Risk Communication: Communicating safety risks effectively to various stakeholders.
Product Labeling: Reviewing and updating product labeling to reflect safety information.
Drug Safety Training
Safety Training Programs: Developing and conducting safety training programs for healthcare professionals and patients.
Safety Awareness: Raising awareness of safety issues among healthcare professionals and patients.
Pharmacovigilance Systems
Pharmacovigilance System Design: Designing and implementing pharmacovigilance systems.
Pharmacovigilance System Validation: Validating pharmacovigilance systems to ensure their accuracy and reliability.
Pharmacovigilance System Maintenance: Maintaining and updating pharmacovigilance systems.