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 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.

What is data management and analysis?

Our comprehensive data management services are designed to support the entire data lifecycle, from planning and Case Report Form (CRF) design to configuration, data handling, cleaning, and study close-out. We leverage a validated Electronic Data Capture (EDC) platform to ensure precision and compliance, making our services suitable for trials ranging from simple to highly complex.

Whether you’re a start-up, a large medical device manufacturer, or another CRO, our services can be seamlessly integrated into full-service CRO activities or provided as a standalone solution. Effective data management facilitates clear communication among stakeholders, ensures accurate data collection, and helps you achieve critical trial objectives.

Individuals reviewing reports or electronic case report forms eCRFs on a tablet or computer

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.

Learn how we work

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.

Regulatory focus

We prioritize compliance with applicable laws, regulations, and guidelines to guarantee data accuracy, integrity, and confidentiality while meeting ethical and scientific standards.

Clear communication

Open, transparent communication ensures alignment at every stage, enhancing collaboration and minimizing misunderstandings.

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.

Resources

Webinar

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Discover how to integrate clinical needs into medical device software design to meet MDR requirements. Watch our webinar on demand.

Whitepaper

Clinical Evaluation for Medical Devices under MDR

This whitepaper will guide you through crucial regulatory documents pertaining to the clinical evaluation process of your medical device. Download now!

Whitepaper

IVDR extension: what does this mean for you?

In this whitepaper, you will learn the impact of the IVDR transition extension and receive tips and strategies to navigate these regulatory changes.

Whitepaper

State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device

This whitepaper will walk you through the steps of conducting solid systematic SOTA literature searches for your clinical evaluation. Download now.

Discover all

Data Management and Analysis

What is data management and analysis?

The needs and challenges we address

How does it work?

Customizable processes

Customizable processes

Regulatory focus

Regulatory focus

Clear communication

Clear communication

Why QbD Group?

Get in touch

Resources

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Clinical Evaluation for Medical Devices under MDR

IVDR extension: what does this mean for you?

State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device