Introducing CentaurAI: AI-Accelerated Regulatory Submissions
Generating a robust, focused, and convincing nonclinical (sometimes called 'preclinical') data package is critical. Failure to appropriately plan and execute a suitable nonclinical development program is a common source of regulatory application failures and delays. We can provide extensive in-house subject matter expertise to assist you in successfully planning and executing such a program.
We help you to define and describe your nonclinical development plan as well as related safety and efficacy endpoints to optimally support your regulatory and clinical strategies.
An effective roadmap to FIH (first-in-human) studies considers both efficacy and safety through the lens of the client's business strategy and risk tolerance. It addresses timeline and budget, including an in-depth expectation of what the client's future capital needs will be over time.
Study design and oversight can take many forms, from package design to execution, data compilation to analysis, and more.
We write and/or review your study protocols, reports, and regulatory submissions, ensuring that essential items are thoroughly and appropriately addressed as well as clearly communicated. Includes preparation of briefing books.
We work with you to understand your development strategy, pipeline asset, Agency interaction timelines, geographical considerations, and operating budget, all with the end goal of identifying, appraising, auditing, and recommending the most appropriate vendor(s) to successfully achieve your objectives.
We oversee your project to achieve your milestones in a timely fashion, including maintaining up-to-date project timelines, organizing project team meetings, capturing meeting minutes, establishing RACI (responsible, accountable, consulted, informed) matrices, and following up on achievement of action items.
.png)
