Development Plan Design and Optimization
Not Just Consulting but Actual Support
To provide you with efficient support, our experts understand and analyze your concept in scientific and economic terms. Together we construct an appropriate development plan based on your specific objectives.
Our support is not limited to “consulting”. We act to help you to construct your development by following the most efficient workflow, step by step. We work to provide you with a relevant scenario for prompt and efficient decision-making should an unexpected event occur.
A Dedicated Methodology for Each Objective
In the early phases, there are two different objectives on which we can act:
The coordination of non-clinical studies in order to justify moving through preclinical studies and first-in-man studies. In this case, we strengthen your dossier and ensure the IND will be accepted by health agencies.
The coordination of Phases I, IIa and IIb, where you will need to manage multiple actors (regulatory agencies, clinicians, data management staff, etc.) and may need to prepare due diligence.
Be Efficient with MBDD
Return on investment is not always at your advantage, especially during the early phases of drug development. Based on your objectives, PhinC can solve this problem by optimizing your development using the principle of Model-Based Drug Development.