Safety Surveillance with Synteract – Your regulatory compliance in the hands of experts you can trust

Synteract's Safety Surveillance group was formed to assist pharmaceutical companies in effectively tracking and managing their products’ benefits and risks. In today's competitive market, a reliable safety team with continuous, timely access to your data is a necessity. We have the expertise to manage all of your safety surveillance requirements, including case data capture, risk assessment, narrative preparation, MedWatch/CIOMS preparation, medical monitoring, and compliant regulatory reporting.

Our team of experienced pharmacovigilance experts consists of PharmDs, RNs, MDs, and other qualified safety personnel. Synteract employs Oracle AERS® software to collect, monitor, and manage safety data. This platform allows us to offer clients secure, real-time access to data and reporting tools via a standard web browser. Oracle AERS is a fully validated, high quality solution which, when backed by our team of experts, ensures that we stand by our promise of quality and flexible responsiveness to your needs.

As you take your products from pre-approval to post-marketing, from Phase I to Phase IV, Synteract has the tools and expertise to handle all of your safety surveillance and pharmacovigilance needs. We provide the assurance to you, patients, doctors, and regulators of the utmost safety tracking of your products. With Synteract, it is always Shared work – shared vision.

Safety Surveillance Services

• Global Safety Plan development
  
• Safety database development and management (Oracle AERS®)
  
• Serious Adverse Event (SAE) case receipt, entry, processing
  
• Preparation of case narratives, MedWatch, and CIOMS forms
  
• Regulatory Submission preparation and reporting
  
• Medical monitoring and medical SAE review
  
• Reconciliation of SAE and clinical databases