Feasibility Assessment Application

With drug development being highly competitive, pharmaceutical companies are facing a wide diversity of challenges, such as the market selection, local clinical research policies and regulations, and patient recruitment. In order to form an effective clinical development plan, a scientific feasibility assessment may be used.

Professional feasibility assessment will help to identify the suitable markets, estimate the number of clinical research sites, establish the basic timeline in clinical trial, and define a feasible clinical development strategy at early planning stages. By taking a close look at existing clinical trial data and relevant regulatory guidelines, feasibility assesments can also minimize risk in the trial by reducing delays and controlling time and cost of R&D.

Parexel’s feasibility assessment covers six core areas. Through data, industry information and practical application, this module goes through the process of constructing a complete clinical research strategy using feasibility assessments.

Werkstatt Objective

• Acquire the basic planning ability for clinical trials: “the mindset of feasibility assessment”
• Master the key strategic consideration in feasibility assessment: country selection, schedule planning , risk analysis, etc.

Workshop Outline

• Protocol Acceptance and Motivation
• Benchmarking Analysis
• Country Selection Strategy
• Site Profile and Investigator Consideration
• Scenario Modeling
• Risk Assessment and Mitigation Strategy