Evolving our partnership with investigators and investigator initiated studies sponsors

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Investigator initiated clinical studies play a critical role in answering important medical and scientific questions regarding our products and related therapeutic areas.

Investigator initiated studies (IIS) are clinical studies initiated, managed and sponsored by non-pharmaceutical company researchers. They improve patient care because they contribute towards enhancing understanding of Roche products and their appropriate applications. These agnostic external studies, consistent with the company’s overall research and development strategies, enhance global understanding of Roche’s medicines and how they can be used to improve patient care. They also spark new ideas for further disease-related research aimed at creating improved treatment for patients.

Customer centric innovation requires a new process

We believe that a globally aligned and efficient IIS process is essential for maintaining an innovative pipeline.

Investigators have requested a simpler and more efficient way to connect with Roche. In response we have developed the IIS Portal. The industry standard IIS Portal enables a streamlined global submission process via a single point of entry, standardized proposal review, and real-time status updates.

The way forward

The new IIS Portal will supplement and enhance existing relationships with IIS sponsors by effectively providing internal and external stakeholders alike with insight into submission requirements, procedures, and IIS review status more effectively.

In summary, the IIS Portal offers a single point of entry for IIS submissions via the web, with a single venue to accumulate all  submission related data. With the more streamlined process, submissions will go directly where needed for review, offering greater transparency into local, regional and global IIS submission related data. This advances the development of medicines in accord with Roche’s commitment to delivering patient impact and innovative decisions and actions, at a speed which recognizes the urgent need for new medical solutions.

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The IIS Portal offers an excellent opportunity to further evolve our partnership with investigators and IIS sponsors alike by establishing a global, single point of access to IIS submissions, and offering visibility into the submission status for all internal and external stakeholders.
Niko Andre, Head of Product Development Medical Affairs

Learn more about our new IIS Portal:

Tags: Science