Development process

 
 


Actelion’s mission to bring innovative medicines to patients can only be realized when vigorous testing of the compounds in its pipeline has been performed, and the resulting data analyzed. Actelion’s Clinical Development department aims to fully explore and describe both the benefits for patients and any potential risks of the compounds. The group works to efficiently develop and bring to the market, on a global scale, innovative pharmaceutical products.

The process is achieved through creative and targeted clinical and pharmacological research – supported by high performance strategic clinical development, biometry, drug safety, drug regulatory, life cycle, and operations functions.

Through life cycle project teams, strategic clinical development initiates and consolidates the processes, from defining the target profile to submission to regulatory authorities. These processes are required to advance innovative compounds through the different phases of clinical development in a rapid and cost-effective manner.

Actelion’s Clinical Science function ensures that all clinical programs adhere to the highest standards of science and medicine, while also ensuring the appropriate generation of all the information required by health care authorities worldwide.

Through global, cross-functional life cycle teams organized by the development function, Actelion ensures the timely development of a product to its full potential – from entry-into-humans through to introduction to the market – and that all appropriate measures are undertaken to maximize the full value creation potential of each product until the patent expires.

The Biometry function with its expertise in the field of statistics and data management, supports the development of Actelion's compounds and, together with Drug Safety, the safety monitoring of marketed products.

 
 

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