.png?width=109&height=108&name=Pharma%20(2).png)
.png?width=111&height=108&name=Medical%20Devices%20(2).png)
.png?width=84&height=107&name=IVD%20(2).png)
Customizable processes
Our team works with you to set up and configure electronic Case Report Forms (eCRFs), ePRO, eConsent, etc, adapting to your specific trial requirements.
Clinical Data Management and Analysis
Are you looking for a reliable partner to ensure your clinical data is collected, managed, and reported with the highest quality and compliance standards? At QbD Group, we understand that clinical data is the backbone of your study's success.
Our Contract Research Organization (CRO) offers a full spectrum of clinical data management services tailored to your study needs, ensuring accurate, efficient, and regulatory-compliant handling of your clinical study's data from start to finish.
The needs and challenges we address
-
Ensuring high-quality data: we deliver reliable, complete datasets that support clinical study analysis and conclusions.
-
Mitigating risks: by addressing data discrepancies and regulatory non-compliance, we reduce risks and enhance study reliability.
-
Adapting to regulatory changes: with the upcoming revision of ICH GCP (R3) emphasizing ALCOA++ principles, we ensure that your data is collected and maintained with the utmost integrity throughout the clinical trial lifecycle.
-
EDC platforms: we secure the use of fully validated electronic data capturing platforms to meet the latest industry standards.
-
User-friendly eCRFs: we ensure that electronic Case Report Forms (eCRFs) are designed with user-friendliness in mind for end-users, such as hospital site staff.
-
Digital transformation and patient-centric approaches: we can set up decentralized EDC solutions for your study, such as ePRO and eConsent, to align with remote and patient-centered trial models.
Our integrated approach streamlines operational activities, ensuring efficiency and precision throughout your trial. We specialize in managing clinical study data, providing the expertise you need for successful outcomes.
Why QbD Group?
A client-centric approach
We place your needs at the center of everything we do. Unlike single-service providers, our comprehensive approach ensures consistency, efficiency, and clear communication across all trial activities.
Multidisciplinary expertise
Our experienced team spans disciplines including data management, medical writing, clinical operations, statistics, and regulatory services. This enables quicker problem-solving and improved project outcomes.
Flexible solutions:
- Simplify the capture, processing, analysis, and reporting of clinical trial data with our advanced tools and methods.
- Avoid the challenges of managing multiple vendors, improving communication and streamlining workflows.
- Meet tight timelines and cost goals without compromising quality.
With QbD Group, you gain a reliable partner committed to your study's success from start to finish. Let us handle the complexities of data management so you can focus on achieving your clinical objectives.
Get in touch
Contact us today to learn more about how our Data Management and Analysis services can drive your clinical trial success!
Resources
Case study
Webinar
Whitepaper
Whitepaper
Whitepaper
Whitepaper
Whitepaper
Case study
.jpg)
Webinar
Webinar
Whitepaper
Case study
Ensuring a smooth MDR transition for Oystershell's medical devices
The landscape of medical device regulations is constantly evolving, making it a challenge for companies to keep up. Our collaboration with Oystershell, which began in July 2023, highlights our expertise in transforming complex challenges into success stories, all with a touch of QbD Clinical magic.
