It is well-established, as in the financial markets, that past performance is no guarantee of future success. However, it serves as a good proxy, and study feasibility, including a detailed outreach to sites, is an essential part of any clinical-regulatory plan.
As part of any study development, Celerion conducts study feasibility at the country, site and protocol levels to both inform the clinical development plans and budgets as well as to better understand the current treatment environment for your indication. It is imperative that a sponsor understand the current treatment options, standards of care – and how they may vary in different geographies – and the competitive landscape that they propose to enter. Further, understanding the regulatory pathway to approval at the site, local and country levels will help to make better and more informed decisions regarding site selection and allow one to understand the trade-offs, e.g. is it worth waiting longer for a site to start if they have greater enrollment potential in the long run?
As with most processes at Celerion, our feasibility process is driven by strong science and is led by therapeutic experts. Evaluating such factors as the mechanism of action, pre-clinical and prior clinical data will assist in assessing risk to the target population as well as critiquing study design elements; most notably the inclusion and exclusion criteria for potential patients. This assessment then provides awareness regarding the patient safety and help to establish the risk-benefit proposition.
Celerion believes that the key to unlocking the value of feasibility analysis with you is the assignment of resources tailored to your needs and requirements. Celerion optimizes utilization of resources by leveraging our organizational strengths, medical and clinical services, gaining process efficiencies and saving time and costs.
Specifically, Celerion provides you with exceptional strategic guidance to support the feasibility and site identification for your study. Experts in the development of protocols and study designs, as well as regulatory and monitoring strategies, all contribute to creating a robust feasibility analysis that will be the basis of your clinical study. Additionally, a strong layer of therapeutically-focused expertise supports the team’s efforts with a deep understanding of the opportunities and risks for your study.
Full Service Global Clinical Development
Celerion, a full-service, early clinical CRO, is the leader in accelerating development for Phase I-IIb. Our unique combination of medical expertise, clinical operations experience and scientific excellence, enables you to make timely decisions with expert advice and high-quality data. Our leadership in clinical pharmacology through Proof-of-Concept is focused on helping you translate your science to medicine.
