Guiding Principles

Godela Health GCP GmbH (LLC) was founded by Dr. Godela U. Bittcher to provide a bridge between clinical excellence and patients for start-ups and existing companies within the healthcare and pharmaceutical industries.

GH GCP is a consultancy for start-ups and existing companies. In close cooperation with stakeholders, GH GCP advises on questions concerning compliance with quality requirements for Good Clinical Practice, according to ICH-GCP E6(R2).

The International Conference of Harmonization – Good Clinical Practice is an international ethical and scientific standard for planning, conducting, documenting, and reporting clinical trials on human patients. The consulting provided by GH GCP includes training, assistance with completing GCP documentation, and preparation for internal and external agency inspections.

  • Adhere to ethical principles according to the Declaration of Helsinki,to protect the rights, integrity and confidentiality of trial participants
  • Provide a bridge between clinical excellence and human participants in clinical trials
  • Strictly follow regulatory requirements to be compliant with the relevant authorities
  • Ensure comprehensive guidance for clients in the complex field of governing regulations
  • Pursue close and transparent cooperation with all stakeholders
  • Ensure continuous improvement in all strategies and processes