Clinical Development Strategy

With increasingly complex regulatory protocols, it is vitally important that clinical development plans are evaluated early and deliberately to avoid costly delays. Our experienced researchers and professionals work closely with you to identify product value, market access and positioning strategies, and offer full-scale support from improving your protocol with the latest market to eliminating the risk of delays.

Fit-For-Purpose Solutions and Strategy

With 17 years of clinical studies experience, Tigermed provides a complete, full-cycle clinical development strategy. We create individualized clinical development plan (CDP) and protocol design service based on the product characteristics and registration application goals.

First-in-class innovation drugs
We develop an overall research and development (R&D) strategy based on the mechanism of action and preclinical data. The strategy includes the selection of indication, design of the key elements of CDP and protocols from Phase I trials to Phase II proof-of-concept trials. The strategy also includes information about first-in-human (FIH) dose determination, PK/PD results interpretation during and after the trial, dose selection and dosing regimen recommendations for late-stage trials, phase II study design, and feasibility analysis of accelerated approval.
Class 1 innovation drugs with competitors on the same target
For Class 1 innovative drugs with competitors on the same target: we analyze the potential advantages and disadvantages of the investigational product based on the results of previous studies, and provide suggestions for the future market positioning of the investigational product; we reference the development situations of similar drugs to optimize the current CDP &protocols, shorten the R&D time, and reduce the R&D cost; or help to explore the path of differentiated development combining the market competition situation.
Improved new drugs
To formulate a clinical research and development plan for an improved new product, we analyze the relationship between the improved product and the unmet clinical need based on the enhanced characteristics of the new product and the clinical application of the originators. After analyzing the disclosed clinical pharmacological factors and the dose-efficacy relationship of the originator, we develop a clinical pharmacology study protocol for the improved new drug and demonstrate whether it is possible to reduce or waive clinical efficacy and safety trials.
The originators marketed overseas under application for being listed in China
We draft a cross-regional population bridging analysis report for the originators marketed overseas under application for being listed in China. The report is formulated based on the indications' characteristics, clinical practice, and clinical pharmacology research data.
Class 3 generic drugs
For Class 3 generic drugs, we combine the product information of the originators and their approved indications. This research ensures that we explore the possibility of waiving clinical trials or designing bridging studies and clinical study protocols with Chinese patients as the study population.

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