DE
  • Expertise
  • Advanced Therapy Medicinal Product

ATMP Clinical Trials

Your specialists for personalized medicine

Our experienced team of specialists has broad knowledge in clinical studies with advanced therapy medicinal products.

 

Our core competencies in ATMP studies:

  • Coordination of complex clinical studies
  • Regulatory handling in different countries of the EU
  • Management of traceability
  • Addressing of ATMP-specific requirements (e.g. Control of donor etc.)

We have performed international first-in-man and first-in-patient studies.
 

Therapeutic approaches include:

  • Venous ulcer
  • Diabetic neuropathic ulcer
  • Ophthalmology
  • Balloons (also drug coated)
  • Heart failure
  • Haemophilia
  • Limbal stem cell deficiency
  • Peripheral arterial occlusive disease
  • Epidermolysis bullosa
  • Acute-on-chronic liver failure
  • Adenocarcinoma

  • Prof. Michael Hudecek, University Hospital Wuerzburg

    Chair of Cellular Immunotherapy

    "Since 2018, FGK has been an invaluable partner in our clinical early-phase CAR-T cell projects. Their extensive experience in advanced new therapies, like ATMP and cell therapy projects, has provided us with the expertise and support needed to navigate this complex field. Their commitment to high-quality research and their deep understanding of innovative therapies make them a trusted and essential partner in our development efforts. We look forward to continuing this successful collaboration.“

  • Christoph Ganss, Rheacell

    Founder & CEO

    “We have been collaborating with FGK for many years, and their professionalism, flexibility, and deep expertise in clinical trials have consistently exceeded our expectations. Their team's ability to adapt quickly while maintaining the highest quality standards has been instrumental in the success of our Phase I/IIa and Phase IIb studies across multiple indications. The involvement of the upper management in all kinds of discussions is highly appreciated, again during our ongoing Phase III trial. We highly value this partnership and look forward to continuing our successful collaboration.”

If you’re interested in our broad experience across managing the complexity of Advanced Therapy Medicinal Product trials, get in touch with us.