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Clinical Research & Development Consulting
The increasing capacities of modern science have created new opportunities for molecular medicine and clinical science along the principles of evidence-based medicine. We support the translation of research advances into clinical applications with special emphasis on robust scientific principles and development methodologies. We facilitate the design, development, and implementation of clinical research solutions to meet your specific needs. With more than 20 years of experience in clinical development and basic research, our goal is to help evaluate and optimize the potential of your drug candidate.

We offer support in:

  • Clinical development strategies and programs
  • Target Product Profiles & Risk Management
  • Development Plans, Clinical Trials Plan
  • Study designs and protocols, with a focus on early phases of clinical development and translational medicine:
    • First administration in human, initial dosing
    • Single or multiple dose tolerance studies, dose-escalation studies
    • Pharmacokinetics (PK/LADME) and pharmacodynamics
    • Mechanism-of-Action studies
    • Proof-of-Concept studies
    • Interaction studies (drug-drug, drug-food, and other interactions)
    • Special population studies (elderly, chronic diseases, etc.) 
  • Study data review and analysis
  • Scientific issues
With thorough knowledge on the requirements of global drug development programs in combination with high expertise in the field of basic sciences, we help you to prove the value of your ideas: competence, experience and commitment for your project.

“Action expresses priorities.”
                                   Mahatma Gandhi (1869-1948) 

© Glasschroeder, 2018, all rights reserved Dr. rer. nat. Birgit Glasschröder