Clinical Trials and Related Consultation Services

If you need help with conducting your research study or any aspect of turning your research into a publication or presentation or if you need an expert’s advice about the scientific process, then Dr. Lewis is happy to share his 25+ years of experience. He has been the principal investigator or co-investigator of over 100 studies in his career, and he can be your go-to source for helping you attain your scientific goals. Some of the specific areas and tasks where Dr. Lewis can help you are:

  • Participate in conceptualization of study design to create a complete study protocol, including target population, sample size, outcome variables, appropriate statistical methods, and other key components
  • Participate in conceptualization of study design to create a complete study protocol, including target population, sample size, outcome variables, appropriate statistical methods, and other key components
  • Write study protocols for institutional review board approval, including modifications, continuing reports, study close-out reports, and other study-related documents
  • Supervise preparation of and deliver product- and protocol-specific presentations to data safety and monitoring boards, internal and external review committees, funders, partners, and collaborators as appropriate
  • Work closely with co-investigators and other study site staff, providing guidance and training as required
  • Ensure trials are completed to the highest standards of quality and ethical conduct
  • Serve as a monitor or evaluator for clinical trials, provide timely review of adverse events, and help ensure compliance with safety reporting requirements
  • Coordinate plans for statistical analyses and blinding and unblinding of data in conjunction with the biostatistician and other study personnel responsible for data management
  • Some statistical analyses can be provided
  • Review data analysis plan and interpret findings in conjunction with co-investigators
  • Generate, review, and approve interim and final study reports and prepare documents for publication and presentation in conjunction with co-investigators
  • Provide input for selecting proper journals for article publication
  • Prepare white papers that are:  (a) well-researched and authentic, based on published science; (b) informative regarding the subject matter; and (c) compliant with all regulatory limitations on valid claims and product statements
  • Ensure timely preparation and submission of clinical investigator brochures and updates, periodic investigational product reports, final study reports, and integrated summaries of safety and efficacy
  • Provide input and expertise to internal groups or external partners/collaborators to help guide product development
  • Attend trade shows and conferences to present study findings and/or products and services
  • Create and maintain clinical and evidence-based sections of target product profile(s) and product development plan(s) for assigned product(s)
  • Serve as a scientific or medical advisory board member

All statements made about any products or services mentioned on this website have not been evaluated by the FDA. Products and services are not intended to diagnose, treat, cure, or prevent any disease.
Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.

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