Phase I and IIa
Whether you therapy is first time in human or a reformulation of an existing treatment, taking a product into early phase development requires careful planning and adept study designs.
Today’s clinical studies are burdened by cumbersome designs leading to increased costs, delays and study failures. More than ever, in early phase studies a design needs to be clear, concise and straightforward, to ensure not only the safety of the participants but also the high quality of each data point entered. Small participant numbers mean if there is missing data as a result of complexity or human error, that can have a profound impact on results.
Additionally, early phase studies should provide insights into the potential of a new therapy. The ability to detect signals predictive of desired clinical outcome early in development can save costs and improve the likelihood of success for later, more costly studies. To do so, it is important that modern clinical development tools and techniques are utilized where appropriate to decrease error and increase efficiency.
As such, we have collected a team of clinical design and protocol development specialists, as well as biostatistics and regulatory experts to understand the requirements of your product and methodically address all considerations. This enables Armstrong Clinical to help you design effective and efficient early phase clinical studies tailored to meet your clinical development objectives.
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