Non-interventional Studies In-House Training

Sophisticated Non-Interventional Studies (NIS) can achieve higher case-numbers, especially in shorter times, needing lower budgets and resources and have to follow less regulatory requirement.

Overview

RCTs (Randomized Controlled Trials) are the Gold Standard for obtaining data on the safety and efficacy of medical therapies in humans - either medical products (“drugs”) or medical devices. But RCTs have some limitations – they are time-consuming with lengthy application processes, low case-number and demanding high budgets and many resources. Sophisticated Non-Interventional Studies (NIS) can achieve higher case-numbers, especially in shorter times, needing lower budgets and resources and have to follow less regulatory requirement. In addition, NIS provide Real-World-Data. NIS might also be helpful to obtain information forming hypotheses for new research projects. In addition, NIS are very suitable to collect long-term-data.

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RECOMMENDATION

Who should attend?

• Project Managers

• Medical/Scientific Advisers

• Medical Affairs Specialists

• in the pharmaceutical or biotech Industry or CROs

• or Staff from Academia, Investigator Site Staff, planning and performing scientific projects

• for Participants from North America, Rest of World, but also from “Europe”