Well-designed translational studies, prototype development, and validation are essential first steps in the process of obtaining the data required for FDA approval to commence clinical studies. The principals at IGBS have decades of experience managing translational research and development efforts for various biotechnology products. IGBS will assist your efforts to design, manage and implement an effective and efficient translational research and prototype development program, thus facilitating successful clinical studies and commercialization. We offer a variety of services to assist conversion of your product concept into a medical device or service ready for clinical validation. · Prototype design and specifications: This begins with an analysis of market needs, market size, and a regulatory precedent review of the government requirements necessary for commercialization. Prototypes can be designed to meet these needs and a cost/benefit analysis can be provided to estimate product feasibility. Specifications detail the performance characteristics that must be achieved to meet market demand and regulatory requirements. We can also provide a SWOT analysis that compares your technology with currently available competing technologies and other technologies that are likely to be competitors in the future. · Technical evaluation and assistance: The principals at IGBS have broad experience in molecular and cellular biology, especially in relation to cancer biology and infectious diseases. In addition, IGBS has a network of highly experienced Ph.D. level scientists with complimentary experience and expertise that extend the knowledge and services that we provide to our clients. We are ready to help you develop and manage a translations research project and analyze the data when the experiments are complete. · Statistical support: IGBS can help you with early statistical support to facilitate down stream project success. IGBS can also assist with robust statistical analysis of preclinical study results. IGBS understands that any good research program begins with a comprehensive statistical power analysis, which in turn lays the foundation for translational research and clinical study design. Good statistical analysis conducted before studies actually begin can reduce expense and risk of inconclusive results. · Strategic Business Planning: We can help our clients write business plans, extramural grant applications and investor presentations. A good research plan is an essential component for all of these documents.