SERVICES

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We offer a wide range of clinical trial management and support services to the pharmaceutical and medical device industries, including project management, clinical site monitoring, quality assurance, and medical writing services.

Consulting

• Product evaluation and strategy
• Organization of external consultant meetings
• Regulatory submissions to FDA and IRBs

Data Management

• Case report form design
  
• Database creation and validation
• Adverse event and medication coding

Project Management

• Customized tracking of patient and site status
  
• Investigator meetings

Medical Writing

• Medical writing of protocols, regulatory applications, study reports, and publications
  

Study Start-up

• Protocol development
  
• Feasibility studies
• Identification and recruitment of qualified study sites and investigators
• Review and negotiation of study budgets and research agreements
• Regulatory document collection and tracking

Statistical Analysis

• Organization and oversight of Data Safety Monitoring Boards
  
• SAP generation and execution
  

Report Submissions

• Investigational New Drug submissions
  
• Institutional Review Board submissions and regulatory document tracking
  

Monitoring

• Clinical site monitoring and data collection
• Good Clinical Practice site compliance

Quality Assurance

• Clinical site audits
  
• Database, report and file audits
  

Specialty Projects

We can also provide experienced, well-trained clinical trial resources to help ease your short-term work crunch and meet impending deadlines. And without any long-term commitments or contracts! LEARN MORE

We welcome the opportunity to discuss your needs or answer any questions you may have about our company or services. Contact us today or complete our inquiry form and we'll get back to you as soon as possible.