helps to optimize the value of innovation

February 29 – thirteenth international Rare Disease Day coordinated by EURORDIS

Strategy

How to collect the most optimal data?
How to avoid post-hoc analysis?
Full scope or subgroup?
Project management

 

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Every project, no matter how small, can be approached in a number of different ways in order to achieve the final objective. A poorly defined objective results in uncertainty, confusion and loss of efficiency. A good strategy begins with a clear definition of the objective and thus setting a measurable goal.

Which data to be collected?

Based on the defined goal (in the future), we look back in time (to the present) and chart the needs and decision points that will shape your final strategy.

The HEBIAS vision is to identify what (clinical) data you will need early in the process and how to best design your study to obtain it. Do you select a ‘single arm’ or a ‘head to head’ study? How many and what patients do you intend to include, and how will you handle follow-up? Do you use EQ-5D data or a simple VAS scale? Are you considering subgroup analyses? …

 

In short, there are a lot of variables to decide on that can directly or indirectly affect your process, and are crucial to making the most optimal decision.

Targeted or dynamic modelling?

And… what if the right data is collected (in a timely fashion), can they be implemented immediately in existing models, or would a custom model be more suitable? Will you choose a ‘targeted economic model’ or a ‘dynamic model’?

Tailor made market access

Let us assume you make the right choices – how will you tackle the process? How will you create a file that simply and convincingly combines the required science and leads to a strong conclusion?

Legislation

Are you familiar with the complex legislation? Do you have all of the required information?

Don’t worry, we will help you along step-by-step with confidence and focus. We are not traditional consultants – we do not want to make the mistakes we experienced back before we were consultants.

 

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MARKET ACCESS =

Clinical trials P & R activities Launch Post Patent activities