Vantage Data Designs provides both Biostatistical and Data Management Strategic Consulting. We have experience in both planning and conducting clinical trials. Not only have we participated in all aspects of clinical trials, but we have practical knowledge in a wide variety of therapeutic areas.

Biostatistical strategic consulting services include:

• Trial Design
• Sample Size Calculations
• Protocol Writing
• Case Report Form Design
• Interim Analyses (planning, execution, reporting)
• Data Safety and Monitoring Board (DSMB)
• Statistical Analysis Planning
• Randomization Schedule(s)
• Regulatory Guidance and Planning
• Clinical Trial Rescue

Data Management strategic consulting services include:

• Selection of data collection methodology utilizing “best fit” technology specific to the criteria of the project trial
• Data Management department setup involving the recommendations for:
  • Data Management organizational structure and job descriptions
  • Hardware and software evaluation, acquisition, and validation
  • Generation and implementation of standard operating procedures
  • Productive and expedient data flow
• Critical review of Protocol and Case Report Form design to optimize accurate and timely data collection, database setup, and data management, statistical and reporting activities
• Preparation and/or review of Data Management documentation to include any or all of the following: Data Management Plan (DMP), Quality Control Plan, Edit (validation) Specifications Document, Clinical Data Review Manual, Data Management QC (quality control) Checklists, Data Management Project Binder
• Definition, creation, and maintenance of validated standardized data collection and data cleaning systems
• Review and selection of Data Management equipment and service providers; negotiation of Data Management contracts
• Regulatory Submissions

Since incorporation, Vantage Data Designs has been instrumental in the production of numerous successful and pending NDA and BLA filings; including the design, statistical production, and writing of clinical study reports, integrated summaries, and other summary documents. We have represented clients at numerous meetings at FDA since 2005. Additionally, Vantage Data Designs has prepared briefing documents, responses to FDA questions, and slides for presentation to the FDA. With our experience, we help guide clients through the regulatory process, from regulatory strategy to client representation at FDA meetings.