«The purpose of human life is to serve, and to show compassion and the will to help others»
Albert Schweitzer
Contact us now for personalised support in all questions related to GCP
Godela Health GCP GmbH –
Your trusted GCP Specialist
In the fast-evolving world of healthcare and pharmaceuticals, the importance of Good Clinical Practice (GCP) cannot be overstated.
GCP ensures an appropriate quality for clinical trials involving human subjects, by providing a framework that follows the ICH*-GCP Guidelines that are mandatory within the European Union, Switzerland and most developed countries.
Godela Health offers you consultancy services that guarantee statutory compliance, deliver upstream expertise to ensure effective trials, and provide expert training. Godela Health can also offer carefully-tailored solutions for your organisation, with project-based GCP solutions that are suitable for both existing companies and start-ups in the field of clinical studies.
*International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
GCP Consultant with over 15 years of experience
Established in November 2023, Godela Health GCP GmbH (LLC) was founded by Dr. Godela U. Bittcher, a specialist in collaborative and consultative GCP. Godela envisioned a company that would not only address the immediate needs of clinical trial stakeholders but also ensure the highest standards of practice within the industry. She is passionate about being able to spread knowledge of GCP more widely, by training and guiding clinical professionals to excel in GCP related processes.
Godela Health operates with a clear mission: to empower established businesses and start-ups in the healthcare and pharmaceutical sectors, by providing support, expert guidance and training to meet statutory GCP requirements in clinical studies.
Godela Health is dedicated to strengthening the link between clinical excellence and patient care, ensuring adherence to ICH-GCP guidelines that are based on the WMA Declaration of Helsinki. This protects the rights, integrity, and confidentiality of clinical trial participants. With an unwavering focus on quality, underpinned by an in-depth knowledge and expertise acquired during over 15 years working as a GCP specialist, the company guarantees the highest standards in all GCP related matters.
Driving Excellence in Clinical Studies
In today’s rapidly evolving healthcare environment, the need for robust, effective and ethical clinical trials has never been greater. As a recognised GCP Specialist, Godela Health believes that every clinical trial is an opportunity to advance medical knowledge and improve patient outcomes. By partnering with us, companies can navigate the complexities of GCP with confidence, knowing that they are accompanied by an expert guide and advisor that will ensure the best possible outcomes.
Our Services
- Whether you are an established company seeking to enhance and strengthen your GCP processes, or a new start-up navigating the complexities of clinical research, we offer a comprehensive suite of key services. These include:
- GCP Compliance Expertise
With more than 15 years of experience, GCP Specialist Dr. Godela U. Bittcher leads the company with an unparalleled knowledge and understanding of clinical trial processes. Her hands-on approach ensures that every client benefits from her expertise, while ensuring full ICH-GCP compliance in all clinical studies.
- Project-Based Tailored Solutions
We recognize that no two projects are the same, so our solutions are carefully tailored to meet the specific needs of each client and every project, ensuring maximum effectiveness and optimised outcomes. - Project Optimisation
By carefully assessing and reviewing your process management, as a GCP specialist we can help to identify gaps in current practices and implementation strategies and thus ensure maximum effectiveness and optimum quality during clinical trials. - Regulatory Documentation
We provide training and assistance in the preparation and submission of end-to-end regulatory documentation in readiness for audits and approval by the authorities. - Data and Archiving
We help to set up easy-to-use databases and an easy-to-search archive.
Our Approach to GCP
- Advice and guidance
At Godela Health our mission is to enhance GCP processes and deliver better outcomes for companies, patients and the broader healthcare industry. We are thus dedicated to providing advice and guidance on all aspects of compliance and requirements for GCP. - A Bridge between Stakeholders
We also strive to build meaningful connections between healthcare companies, pharmaceutical organisations and clinical trial patients. By fostering collaboration, we aim to create a more effective and ethical ecosystem for clinical trials.
- Patient-Centered Approach
While maintaining full compliance during clinical trials, we also encourage an ethos where the health of participants is paramount. - Training
Godela Health provides training that ensures a full understanding of the necessity of closed-loop documentation that is compliant.
Meaningful and effective collaboration
Collaboration lies at the heart of Godela Health’s working philosophy. We understand that the landscape of clinical research is dynamic and complex, requiring a nuanced approach that balances regulatory requirements with the clinical and practical needs of stakeholders.
- Relationships
We focus on building strong collaborative relationships that form the bedrock for delivering consultative services that are centred on clinical research needs and patient welfare. To construct a meaningful and effective consultancy, the main pillars of our work are: - Expert advice and guidance
On GCP compliance, from protocol development to regulatory submissions.
- Dynamic support
During inspections and audits of clinical processes, and to guide informed decision-making. - Empowerment
Of clinical professionals, by providing the knowledge and skills needed to excel in GCP processes.
The collaborative and consultative ethos of Godela Health not only fosters strong partnerships, but also delivers measurable value for each of your projects. Partner with GCP specialist Godela Health to ensure that your clinical trials achieve maximum effectiveness and are built on a foundation of compliance, quality, and ethical integrity. From established organisations to start-ups, we tailor our GCP solutions according to your unique challenges.
Contact us now and let’s achieve excellence together.