Clinical Development from Phase 0 to IV

Clinical Trials (CT) are part of our life.

Juergen started being engaged in CTs in 1987 at UKE with a CT on IBDs. Since that time clinical trials and everything related is his highest challenge and at the same time the most fulfilling work.

Problem solving, looking for unexpected solutions and for new ways is his experience and strength. Combining RA, GCP and related legal and regulatory requirements is the target. The result anticipated should be the most reliable way to Market Approval and Market Access.

  1. To start with, designer drugs or products having no „families“ should be evaluated by an expert.
  2. If reasonable the Innovation Offices of BfArM, PEI or EMA should be involved and their expertise used.
  3. Phase 0 to ensure that such a compound is checked to be as far as possible w/o unexpected risks.
  4. Phase II to ensure that all aspects regarding Market Approval and Access are looked at and that all advises offered are looked at and used if helpful.
  5. Phase III is the key and therefore the prep-work is the basis to success.

All this should be standard. But is it?

Especially in startups and SME the day to day work is so challenging and time consuming that quite often things like the above are not in the focus. Maybe an important point for you and a point where we offer help and solutions.

CT Clinical Trials Toolkit-Roadmap

UK offers an interesting and challenging solution to become really familiar with all the aspects making clinical trials from the idea to the report so challenging. This Blue Print is a motivation for us to provide comprehensive, state-of-the-art knowledge!

The Toolkit as of November 2022