Clinical Development

How we operate

The clinical development department is comprised of three teams who integrate their activities in order to co ordinate all activities relating to the conduct of Phase I to III clinical studies.

The Clinical Operations team consists of clinical trial managers and clinical programme managers, who are responsible for the timelines, budget and overall quality of the clinical trials.  Although Norgine outsources the majority of clinical trials to specialist service providers, the in-house managers retain oversight of the trial process and form the key liaison to the rest of Norgine. The managers ensure that patient safety, data quality, scientific validity and the integrity of the trial is maintained throughout by adhering to the principles of Good Clinical Practice, local legislation and guidelines.

The Medical Writing and Data Management team is responsible for generating documents relating to individual studies, such as the clinical trial protocol and the clinical study report, which is provided to the Regulatory Affairs department within Norgine for submission to the Regulatory Authorities, as well as for the collection and processing of data throughout the study.  In addition, the Medical Writing and Data Management team generates documents summarising all studies that have been performed with each compound, such as safety reports which are required by the Regulatory Authorities on an annual basis, and the clinical overviews required for first registration.  Finally, this team is responsible for ensuring that details of all clinical trials conducted by Norgine appear on regulated databases available to the public, and where appropriate, that any data generated are available in the public domain.

The final arm of the clinical development department is that of Clinical Science.  The aim of Clinical Science is to work with Norgine’s Exploratory Opportunities Team and external academic experts to identify new concepts, development opportunities and research strategies.