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 provides a useful framework and ensures the quality of clinical trials involving the participation of human subjects, adopting and following the «ICH GCP Guidelines of Declaration of Helsinki».

As GCP Specialist, Godela Health offers consultancy services to ensure compliance and offers training and tailored solutions for your organization. Contact us now for personalised support on your GCP matter.

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. The idea was born out of a deep passion and enthusiasm for training and guiding clinical professionals to excel in GCP related processes. As GCP Specialist, the company provides project-based and tailored GCP solutions for each individual client. Services include start-ups as well as established companies in the field of clinical studies.

Dr. Godela U. Bittcher envisioned a company that would not only address the immediate needs of clinical trial stakeholders but also elevate the standards of practice within the industry.

The company operates with a clear mission: to empower start-ups and established businesses in the healthcare and pharmaceutical sectors by providing knowledge, training and support in meeting the necessary GCP requirements in clinical studies.

The company is dedicated to bridging the gap between clinical excellence and patient care, ensuring adherence to the ethical commitment according to the «ICH GCP Guidelines of Declaration of Helsinki», protection of rights, integrity, and confidentiality of clinical trial participants. With an unwavering focus on quality, with deep knowledge and expertise, acquired in over 15 years of experience as GCP specialist, the company guarantees high quality standards in all GCP related matters.

Driving Excellence in Clinical Studies

In today’s rapidly evolving healthcare environment, the need for robust, ethical, and efficient clinical trials has never been greater. As GCP Specialist, the company believes that every clinical trial is an opportunity to advance medical science and to improve patient outcomes. By partnering with us, companies can navigate the complexities of GCP with confidence, knowing they have a trustworthy advisor by their side.
Whether you are a new start-up navigating the complexities of clinical research or an established company seeking to enhance your GCP processes, we offer a comprehensive suite of key services, including:

GCP Compliance Expertise
With more than 15 years of experience, GCP Specialist Dr. Godela U. Bittcher leads the company with unparalleled knowledge and insights into clinical trial processes. Her hands-on approach ensures that every client benefits from her expertise. And ensures compliance in all clinical studies.
Regulatory Documentation
Training and assistance in preparation and submission of an end-to-end regulatory documentation ready for audits and for the approval by the Authorities
Project-Based Tailored Solutions
We recognize that no two projects are the same. Our solutions are project-tailored to meet the specific needs of each client, ensuring relevance and effectiveness.

Questions Concerning GCP
At Godela Health GCP GmbH, we are passionate about what we do. Our dedication to enhancing GCP processes translates into better outcomes for patients, companies, and the broader healthcare industry, by advising on questions concerning compliance with quality requirements for GCP.
Training
Godela Health GCP GmbH provides an in depth understanding of the necessity of closed-loop documentation to be compliant.
Archiving
working on an easy-to-search archive and implement easy-to-use databases
Patient-Centric Approach
promoting an awareness that while maintaining compliance during clinical trials, the health of the participants must come FIRST
Process Optimization
By taking a close look and assessing your Process management, the GCP specialist identifies gaps in current practices and implements strategies to improve efficiency and quality in clinical trials
Bridge Between Stakeholders
Our mission extends beyond compliance; we strive to build meaningful connections between clinical trial patients, healthcare companies, and pharmaceutical organizations. By fostering collaboration, we help create a more efficient and ethical clinical trial ecosystem.

Collaboration lies at the heart of Godela Health GCP GmbH’s philosophy. We understand that the landscape of clinical research is dynamic and complex, requiring a nuanced approach that balances regulatory requirements with the practical needs of stakeholders.

Driven by deep understanding and meaningful collaboration

Our focus is on building strong collaborative relationships, which form the foundation for delivering human centric consultative services as projects progress. In order to form a meaningful and sustainable consultancy, the main pillars of our work are:

Expert advice and guidance
on GCP compliance, from protocol development to regulatory submissions
Support
in inspections and audits of clinical processes to guide informed decision-making
Empowerment
of clinical professionals with the knowledge and skills needed to excel in GCP processes

The collaborative and consultative ethos of our GCP specialists not only fosters strong partnerships but also ensures, that every project the company undertakes delivers measurable value to our clients.

Partner with Godela Health GCP GmbH to ensure your clinical trials are built on a foundation of compliance, quality, and ethical integrity. From start-ups to established organizations, we tailor our GCP solutions to your unique challenges. Contact us now and let’s drive excellence together.

Godela Health GCP GmbH – Your Partner in Good Clinical Practice.