About me
About me
Dr. Godela U. Bittcher is the founder of Godela Health GCP GmbH (LLC), your partner in best clinical practice.
From teacher to scientist: after being a secondary school teacher for many years, she resumed her studies and in 2004 graduated from the University of Basel with a PhD in Neuroscience. Godela then worked for over 15 years in pharmaceutical companies, specialising in clinical practice during patient-based clinical studies.
By developing her knowledge and experience in Good Clinical Practice (GCP), she succeeded in creating an alignment between the operational and quality teams, and encouraged a strengthened collaboration between departments to ensure that it was seamless. She also excelled in preparing clinical teams for audits and inspections by the regulatory authorities.
Foundation
Her enthusiasm to train and guide clinical professionals to excel in GCP-related processes, lead to the foundation of Godela Health GCP GmbH (LLC) in 2023. The goal is to provide a bridge between clinical excellence and trial patients, for start-ups and existing companies within the healthcare and pharmaceutical industries.
Consulting services provided by the company, include training, guidance and assistance with implementing GCP as part of clinical trials, completing GCP documentation, and preparation for internal and external agency inspections (see «Key Services»).
Guiding Principles
Adhere to ethical principles according to the Declaration of Helsinki to protect the health, rights, integrity, and confidentiality of trial participants
- Close and transparent cooperation with all stakeholders to ensure that all clinical trials progress smoothly and successfully
- Continuous improvement of strategies and processes
- Ensure strict adherence to regulatory requirements, to be compliant with the relevant authorities
- Comprehensive guidance in the complex field of governing regulations