Safety

In today’s global environment, appropriate and timely management of Safety related issues has become increasingly important for successful device development. Due to a dynamic and diverse regulatory environment, safety reporting  conducted during pre- market clinical trials is becoming increasingly complex, particularly when dealing with multinational trials.  In addition, the reporting of incidents either as part of a Post-Marketing Surveillance plan or during a post-marketing clinical trial has greater significance.  In D-TARGET we recognize the challenges associated to identifying and assessing risks during clinical trials. D-TARGET team of physicians and safety officers will provide the required knowledge and expertise to work with you and quickly respond to a rapid changing regulatory environment in a timely manner.   

    
D-TARGET offers the following services:    
    
• Safety Management Plans (SMPs)    
• Medical Monitoring Plans    
• Collection, assessment and reporting of safety information:  Serious Adverse Events, Incidents, and other significant safety events.    
• Narrative writing    
• Assessment and evaluation of event reportability and submission of safety reports to Competent and regulatory Authorities in Europe and USA    
• Adverse event management    
• SAE Reconciliation    
• SAE database management    
• Periodic Safety Reports
• Medical coding
• Adverse event information coding
• Post-Marketing Surveillance Reports
• Medical data Review
• 24-Hour medical monitoring