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Medical writing
Preparing essential documentation for regulatory and scientific audiences.
Clinical Study Operations
Bringing a new medical device or product to market comes with a unique set of challenges—from regulatory hurdles to collecting the necessary clinical evidence.
At QbD Group we understand these complexities and offer solutions to help you overcome them. We focus on setting up and managing your clinical landscape to meet your specific objectives.
Whether you need end-to-end clinical study support or assistance with specific aspects, together, we can turn your vision into reality.
A partnership built on trust and expertise
We approach clinical study operations as a partnership. Our process is centered on clear communication, transparency, and mutual trust. By understanding your unique challenges and goals, we create tailored plans to ensure the success of your clinical study.
Focused project management
Our experienced project managers act as your primary point of contact, ensuring your clinical trial is executed smoothly from start to finish. They manage:
- Planning, execution, and completion: delivering successful clinical studies with precision.
- Budget management: keeping your project on track financially.
- Timelines and objectives: Monitoring progress and meeting milestones.
- Study team coordination: Building and managing the clinical study team.
Expert Clinical Research Associates (CRAs)
Our CRAs bring unmatched expertise to the table. Their strengths include:
- Local language proficiency: seamlessly navigating cultural and linguistic nuances.
- Therapeutic expertise: supporting a wide range of therapeutic areas.
- Commitment to quality: focusing on deliverables and adhering to the highest standards.
Customized team building
We know that the right team and therapeutic expertise are key to a successful clinical study. At the start of each project, we assess your needs to build a team with the ideal skills and experience.
Your dedicated project manager is the single point of contact, oversees all activities, and coordinates with vendors when necessary. We are also investing heavily in involving CTA's in our projects, which adds administrative value by supporting our PMs and CRAs to efficiently and successfully manage the project.
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A partnership built on trust and expertise
We approach clinical study operations as a partnership. Our process is centered on clear communication, transparency, and mutual trust. By understanding your unique challenges and goals, we create tailored plans to ensure the success of your clinical study.
Focused project management
Our experienced project managers act as your primary point of contact, ensuring your clinical trial is executed smoothly from start to finish. They manage:
- Planning, execution, and completion: delivering successful clinical studies with precision.
- Budget management: keeping your project on track financially.
- Timelines and objectives: Monitoring progress and meeting milestones.
- Study team coordination: Building and managing the clinical study team.
Expert Clinical Research Associates (CRAs)
Our CRAs bring unmatched expertise to the table. Their strengths include:
- Local language proficiency: seamlessly navigating cultural and linguistic nuances.
- Therapeutic expertise: supporting a wide range of therapeutic areas.
- Commitment to quality: focusing on deliverables and adhering to the highest standards.
Customized team building
We know that the right team and therapeutic expertise are key to a successful clinical study. At the start of each project, we assess your needs to build a team with the ideal skills and experience.
Your dedicated project manager is the single point of contact, oversees all activities, and coordinates with vendors when necessary. We are also investing heavily in involving CTA's in our projects, which adds administrative value by supporting our PMs and CRAs to efficiently and successfully manage the project.
Why QbD Group?
Choosing QbD Group means choosing a partner with the expertise, resources, and dedication to support your clinical studies from start to finish. Here’s why:
- Trusted expertise: a proven track record of successful clinical studies.
- Local and global reach: combining regional insights with international experience.
- Regulatory knowledge: deep understanding of medical device and IVD regulations.
- Tailored solutions: crafting strategies to meet your unique challenges.
- Comprehensive services: offering a wide range of in-house expertise to streamline your clinical research.
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Get in touch
Ready to start your clinical trial journey?
Contact us today to discuss your project, and let’s work together to bring your innovations to life.
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