Synteract Can Host Your Safety Surveillance Platform

Synteract’s safety group is experienced in assisting clients meet their safety obligations, both during clinical trials and after product approval. We work closely with clients to develop safety data collection and reporting processes, customizing the safety database to meet the unique needs of your product or study while still realizing the fullest potential of our safety software platform.

Oracle AERS Software Meets the Needs of Global Organizations

Synteract uses Oracle AERS® (Adverse Event Reporting System) software to collect, monitor, and manage safety data from clinical trials and spontaneous reporters. Oracle AERS® is a full-featured adverse event reporting system designed to meet the needs of global pharmaceutical, biotechnology and medical drug companies and the contract research organizations (CROs) that support them. The system provides proven performance and scalability to quickly respond to evolving user needs from product discovery through major global product launches and post-marketing pharmacovigilance.

Oracle AERS was designed to meet the requirements of multinational pharmaceutical companies engaged in the development and marketing of high demand, internationally available products, to facilitate international product development and safety surveillance.

Oracle AERS can be configured to support the safety data processing needs for product development, regulatory submissions, and post-marketing surveillance, while maintaining the advantage of a single data repository.

Oracle AERS features include:

• Clinical and post-marketing adverse event case management
  
• Product complaint management
  
• Management of medical inquiries
  
• Regulatory reporting and tracking
  
• Ad hoc querying
  
• MedDRA, WHO-drug auto-encoding
• Pharmacovigilance and trend analysis capabilities
  
• Document management
  
• Correspondence log
  
• E2B import and export

For more information, see this datasheet.