One of the truly unique aspects of iCardiac is the deep scientific and regulatory expertise we are able to bring in helping sponsors of all sizes to navigate the challenges of conducting cardiac and respiratory studies. Our scientists, cardiologists and statisticians are highly experienced in the design and implementation of studies at all phases and of all complexity levels. Further, our scientists closely collaborate with regulators and other thought leaders in the industry, providing them with unparalleled insight into how studies should optimally be designed to satisfy regulatory scrutiny and into what methodologies will best serve a sponsor’s needs.
iCardiac provides the following consulting services:
- Initial feedback about study design and plans (complimentary as part of sponsor evaluating iCardiac)
- Drafting of study synopsis or protocol
- Development of Statistical Analysis Plan
- Standard or unique statistical analysis
- Drafting of cardiac safety and similar reports
- Assistance with regulatory submissions or interactions
- Review of past study results and re-analysis
Complimentary Scientific Consultation
Additionally, iCardiac recognizes that one of the most important times during which a sponsor could benefit from scientific consulting expertise is when it is deciding which centralized core lab to use. Therefore iCardiac provides complimentary scientific consultation to help sponsors evaluate our capabilities and expertise. These complimentary services often include iCardiac providing detailed feedback to the sponsor about its study plan, including ways that the study design may be optimized to maximize the likelihood of study success or to minimize cost.