We Provide Comprehensive Clinical Operations Services From Protocol Development to FDA Submission

Clinical operations is a critical component in all studies. Synteract’s highly skilled staff is well-versed in designing, implementing and monitoring clinical trials. From study start-up to close-out, experienced clinical managers and CRAs (clinical research associates) oversee each study’s clinical processes to ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between study sites and sponsor. With experienced regional monitors located throughout the United States and around the world, we provide cost-effective yet efficient monitoring services.

Whether helping your organization handle an overload of work on a single project or designing a full-service clinical program for your product, Synteract has experienced knowledgeable staff members ready to assist you.

Quality Training of Clinical Associates Ensures Quality Outcomes

CRAs undergo a thorough instructional regimen and are trained on Synteract’s clinical standard operating procedures, clinical guidelines, and monitoring tools. In addition, clinical team members are educated on FDA regulations and ICH guidelines related to clinical trials, as well as good clinical practices. These learning processes, along with protocol-specific training prior to monitoring, ensure your study will deliver the quality outcomes you expect.

Responsible Study Start-up and Clinical Trial Monitoring

Synteract’s clinical team can help ensure the right investigational sites are identified, coordinate regulatory submissions with sponsor personnel, and manage the monitoring process both domestically and globally. We’ll set up and maintain the Trial Master files and will define a monitoring plan that supports the study design. By anticipating and resolving potential problems early, our clinical group keeps studies on track.

CRAs at Synteract are experienced personnel, and serve as the primary point of contact for the study sites. They are responsible for monitoring a site's activities throughout the clinical study, including site qualification, initiation, interim and closeout visits. We provide our monitors with all the tools they need to ensure monitoring activities are consistent and of the same high quality across all of our projects.

Monitoring Tasks Handled for You by Synteract

• Study Start-up including regulatory document management
  
• Site identification
  
• Site qualification
  
• Site initiation
  
• Interim monitoring
  
• Site closeout
  
• Site management and support