Clinical development consulting

Yes, Nuvisan offers clinical development consulting services across a broad range of areas. These include advice on specific scientific and regulatory questions, preparation and review of documents required for clinical trials in humans, and support for the design and refinement of clinical trials. Nuvisan also supports the transition from the preclinical to the clinical phase, including assessment of non-clinical requirements, calculation of the maximum recommended safe starting dose and definition of dose steps in first-in-human studies. In addition, Nuvisan provides broader regulatory consulting, including support for scientific advice procedures at national and European regulatory agencies, as well as preparation of integrated clinical development plans.

No. Nuvisan offers regulatory and clinical consulting as standalone services. These services can support an ongoing clinical development program, help prepare clinical trials in humans or address specific questions that arise during the regulatory approval process. Nuvisan can contribute at any stage of development. Where Nuvisan provides both consulting and trial delivery, the process may be more efficient for the customer. However, customers can choose the services that best meet their needs.

Yes, Nuvisan’s clinical and regulatory consultants bring extensive experience in the pharmaceutical industry and the CRO sector. The team includes specialists with experience in clinical development and regulatory consulting, including board-accredited expertise in clinical pharmacology. Where specialist input is required in a particular therapeutic or scientific area, Nuvisan can also arrange advice from external clinical experts.

Consulting fees depend on the scope, type and duration of the work. Where consulting relates to a specific study, the cost can be included in the study budget. For standalone consulting services, Nuvisan can agree an hourly rate and an estimated range of hours in advance. Only the hours worked are billed, and time is recorded accordingly. Where a customer requires ongoing access to consulting support over a longer period, Nuvisan can also offer a retainer or service agreement.