Clinical Development Reports: Path to Market
Start with the end in mind.
Demonstrating therapeutic efficacy and safety is necessary, but alone, not sufficient for a cost-effective development program or successful commercialization. A well-thought-out strategic development plan is an essential tool for improving efficiency, reducing costs, shortening timelines, and increasing the probability of success for a new therapy.
Complex process in drug development requires the coordinated efforts of diverse disciplines, including nonclinical, clinical, regulatory and commercial experts. At Armstrong Clinical we have the expertise to forecast a detailed clinical development plan that maps your path to market for your target indication. A multi-disciplinary project team of experienced experts collaborate in preparing this plan, which outlines the key nonclinical studies, regulatory strategy, Phase I-III clinical trials, chemistry, manufacturing, and controls (CMC) regulatory submissions and FDA/EMA health authority interactions.
Objectives required each stage development, targeted decision gates at critical junctures and major development milestones help provide confidence in accurate development forecasts, expectations and certainty in further development and investment decisions. The strategic plan can include alternative development options or scenarios that help companies avoid or mitigate risks.
Armstrong Clinical helps provide clients an integrated drug development plan, specific to the product, indication and current treatment practice provides a detailed roadmap for advancing a new compound though each stage of development, ultimately arriving at the envisioned marketed drug product Our specialists clinical development, regulatory, CMC, pricing and translational medicine will help ensure you are capturing the right information in the most effective means to enable you to confidently progress to the next stage of development and beyond.