Taking your medical innovation from concept to approval is filled with strategic decisions and the path to approval you follow can increase or decrease your chances of success. The environment in which you are operating in is changing and your strategy must adapt accordingly. We help you find the right strategy for your product and re-evaluate it regularly by comparing strategies, assessing the competitive landscape and collecting feedback from the right experts.
Each study in your clinical development program addresses specific questions about your product’s safety and efficacy profiles. Designing the study to address these questions effectively is a balance between complexity and feasibility. Restricting the study to a well-defined patient group and capturing the desired amount of measures is met with the challenges of subject recruitment and retention in the study. Previous success and failure will help guide your decision on study design then validate it in consultation with the different stakeholders.
Your selection of contract research organization (CRO) and investigator sites has everything to do with obtaining quality results on budget and on time. Selecting a CRO with the right capabilities and experience is the obvious part but there’s much more to consider, including for example the types of sites the CRO has access to, the teams assigned to your study, the quality assurance measures in place and the risk mitigation strategies. Past performance and stability (both financial and organizational) are also critical factors to consider. We regularly assess and evaluate sites and CROs to give you quick access to the right teams to execute successfully.
Launch Your Project
Leverage historical data to avoid operational failure in the clinical development of your product. Our tools help you optimize your development plan, improve your study design, and strengthen your execution strategy.