Trials

Becker Consulting supports the development of new healthcare products through all phases of product testing. We utilize our clinical and regulatory experience in combination with our expert network to design efficient product testing programs responsive to both client business needs and the latest standards of scientific evidence and clinical practice.

We regularly develop complete testing programs for clients, providing study summaries, timelines and budgets for bench, animal and clinical trials in the United States and abroad.  Our recommendations are optimized to meet companies' internal milestones and fundraising targets.  Throughout the testing program, we offer expert support as needed, by assisting with study organization and setup, protocol and report authoring, good clinical practices training, regulatory interactions, statistical analysis, and presentation of study results in regulatory and other forums.		 Becker™ Trials Services:
  • Preclinical and Clinical Testing Strategy and Study Design
  • Statistical Analysis Plans, Data Analysis, Study Reports
  • US and EU Regulatory Requirements, including FDA and Notified Body Interactions
  • IDE, IND, IRB and Other Submissions
  • Study Site and Investigator Selection
  • Contract Research Organization (CRO) Management
  • Clinical Trial Forms and Document Management
  • Monitoring Services, Good Clinical Practices Training
  • Analysis, Interpretation and Presentation of Study Results