Clinical Data Consultancy Team

biometrics_consultancySponsors often need to overcome protocol design, data analysis and quality assurance challenges and need to be certain of providing satisfactory answers to regulatory bodies. CROS NT’s Clinical Data Consultancy Team anticipate, and resolve in advance, issues related to Biostatistics, Data Management and Quality Assurance.

Biostatistics Data Management Regulatory/QA
Protocol Design & Statistical Methodology Streamlining data management processes Implementing Quality Management Systems
Adaptive Trial Design & Bayesian Framework CDISC Implementation and Mapping Strategy SOP and QA Manual Support
Making Sense of Clinical Data: Data Mining, Reporting Clinical Data Transparency guidance GxP and Internal Audit Support
Special Considerations for Oncology Trials Guidance on EDC Technology selection Vendor Auditing
Special Considerations for Medical Device  Global Data Strategy Computer System Validation
Risk-Based Monitoring Risk-Based Monitoring Risk-Based Monitoring

The Team

The Consultancy Team is composed of members from across Europe and the United States who have experience in a variety of therapeutic areas and trial phases as well as supporting with meetings and answering questions from the EMA and FDA. The Team is led by Thomas Zwingers, Director of Consultancy Services, who has over 30 years of experience in the clinical trial environment. His team includes:

  • Biostatisticians in Europe and the U.S. with 15-25 years of experience with both the EMA and FDA
  • Data Management experts with over 20 years of experience on clinical data management processes
  • Quality Assurance Consultants with over 20 years of experience in implementing quality management systems in the GxP environment