Proven Experience

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Regulatory Submissions

Since its incorporation, Veristat has been instrumental in the production of 14 successful and pending NDA/CTD and BLA filings, including the design, statistical production, and writing of clinical study reports, integrated summaries, and other summary documents. This experience is specifically within the context of Veristat itself. Veristat employees individually have additional NDA and BLA experience from previous positions in the pharmaceutical industry.

FDA Interaction

In his role as a strategic statistical consultant, John Balser has represented clients at 20 meetings at FDA since 2000. In addition, Veristat personnel have prepared FDA briefing documents, responses to FDA questions, and slides for presentation at Drug Advisory Committee meetings. Veristat personnel also have attended Drug Advisory Committee meetings to assist clients with real-time data presentation in response to committee member questions.

Statistical Analyses and Medical Writing

Veristat has extensive experience with the production of statistical analyses and clinical documents. Descriptions of tasks performed in specific indications are available upon request.

Therapeutic areas of experience include:

• Allergy
  
• Anti-Infectives
  
• Cardiovascular
  
• Diagnostic Agents
  
• Gastrointestinal
  
• HIV/AIDS
  
• Medical Devices
  
• Metabolic and Endocrine Disease
  
• Oncology
  
• Respiratory
  
• Reproductive Health
  
• Rheumatoid Arthritis
• Transplantation
  
• Vaccines