Clinical Trial Operations

The Clinical Operations (ClinOps) team covers the full spectrum of clinical trial activities setting for pre-market to post-market follow-up studies, including project management, site selection & qualification, site training and management, risk-based monitoring (on-site/remote) and project logistics.

What?

How

Analytical-method-validation-and-development-Services-QbD-Oct-07-2024-11-22-19-7246-AM

Why QbD Group?

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Question 1

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Question 1

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Resources

Case study

Validating a Complex Autoclave Load to Enhance Sterilization Efficiency

Discover how QbD Group helped a pharmaceutical facility in Barcelona optimize and validate a complex autoclave load, improving sterilization efficiency and manufacturing flexibility.

Case study

Fast-Tracked Site Qualification for Clinical Trial Submission

QbD Group helped a biotech company complete 5 site qualification visits in just 3 weeks enabling a timely and compliant clinical trial submission.

Webinar

Pharmacovigilance and Risk Management in Innovative Therapies: A Challenge in Drug Safety

Explore pharmacovigilance in cell, CAR T, and RNA therapies. Join our webinar to tackle tomorrow’s drug safety and risk management challenges.

Webinar

Extractables & Leachables in Pharma: Navigating Evolving Regulations and Toxicological Challenges

This webinar aims to provide a comprehensive overview of Extractables and Leachables (E&L) in pharmaceutical products, highlighting regulatory complexities, toxicological challenges, and practical approaches to study design and risk assessment across the product lifecycle.

Whitepaper

A Complete Guide to Computer System Validation

This guide aims to bring context and define the necessary and appropriate strategies for the validation of computerized systems. Download now.

Whitepaper

Digital Health - Exploring the landscape and future opportunities

This whitepaper informs you about digital health, key technology pillars, and new opportunities to anticipate future trends in your healthcare sector.

Whitepaper

ISO 13485:2016 - Compliance Checklist

Are you up to date with the latest medical device QMS requirements? Download our free ISO 13485:2016 checklist to ensure compliance.

Case study

Enhancing data integrity & aseptic manufacturing compliance

QbD Group helped a leading medical tech company improve MDR compliance and enhance aseptic manufacturing for long-term regulatory readiness.

Case study

A Decade of Excellence: Linguistic Review Support for a Global Pharma Leader

QbD Group streamlines linguistic reviews for a leading pharma client, ensuring compliance and accuracy across 25 EU/EEA languages while meeting stringent regulatory deadlines.

Whitepaper

ICH Stability Studies on Pharmaceuticals

This whitepaper discusses the importance of different methods for testing the stability of pharmaceutical products, stability study guidelines, and other aspects related to the stability of pharmaceutical products.

Whitepaper

EU GMP: How to import your products into the EU?

Are you a medicinal product manufacturer looking to import your products into the EU in line with the latest EU-GMP import regulations? Download our guide.

Case study

Scalable MSAT validation support for seamless compliance & efficiency

Discover how QbD Group helped a global pharmaceutical company address fluctuating validation demands across multiple teams.

Case study

Restoring manufacturing timelines through expert deviation management

Discover how QbD Group helped a leading biotechnology company overcome a backlog of deviations, restoring timely batch release through expert QA support.

Case study

Guiding a global biotech company through ATMP facility qualification

Discover how QbD Group supported a global biotech company in commissioning and qualifying two ATMP therapy production sites, ensuring compliance and efficiency.

Whitepaper

How to keep computerized systems in the operational phase

Ensure compliance and efficiency with best practices for maintaining computerized systems in the operational phase. Download our expert whitepaper now!

Whitepaper

Medical Device Regulation (MDR) Checklist

Implement the Medical Device Regulation (MDR) with ease. Download our checklist of mandatory documents for MDR compliance.

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

Regulatory Affairs for Pharma and Biotech

In this flyer, you will learn more about the regulatory services QbD Group provides for the pharmaceutical and biotechnology industries.

Webinar

From Requirements to Code: a unified MDSW development cycle that covers all requirements

Watch our webinar on demand to master medical device software development. Learn about IEC standards, cybersecurity, AI integration, and FDA expectations.

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.

Webinar

From Concept to Market: Comprehensive Market Access Strategies for Medical Device Software

Learn how to launch your Medical Device Software successfully with expert insights on market access and commercialization strategies. Watch our webinar on demand.

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.

Webinar

Drug-Device Combination Products and Article 117

Explore the regulatory complexities of Drug-Device Combination Products. Learn about Article 117 requirements, Notified Body Opinions, and more.

Whitepaper

Mobile health on the rise: exploring the regulatory landscape for reimbursement

This whitepaper will help you navigate the maze of the DTx regulatory environment, highlighting several important countries and regulations.

Whitepaper

Clinical investigations under MDR: key insights and practical experiences

This whitepaper covers clinical investigation authorization under MDR, the EU Legal Representative's role, and the MDR's impact on study conduct and post-market surveillance.

Whitepaper

The pathway from idea to patient under MDR

This guide explains the pathway and steps needed to test your device in human subjects, aiming to get your product to market. Download now.

Webinar

Unlocking Strategic Value in Drug Safety for Life Sciences Organizations

Explore how drug safety teams can transform into proactive benefit drivers with the right tools & resources in this webinar on demand.

Case study

CE Mark Renewal for bioXtra Products: A Success Story

Discover how Lifestream Pharma successfully renewed the CE mark for their BioXtra Dry Mouth products under the EU MDR. Learn about the challenges faced, the approach taken for compliance, and the results achieved.

Webinar

Technical Documentation Essentials for Medical Device Software

Gain practical insights on crafting MDR-compliant technical documentation for Medical Device Software.

Whitepaper

GAMP 5 Software Validation Approach for GMP, GCP and GLP regulations

Learn how to comply with GMP, GCP, and GLP regulations using the GAMP 5 Software Validation Approach. Download the whitepaper for more insights.

Webinar

How to manage mandatory communication of Toxicological Risks?

Learn how to effectively manage toxicological risks in the pharmaceutical industry by addressing, reporting, and mitigating potential harm.

Webinar

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Watch our webinar on demand and learn about regulatory obstacles, MDR, AI Act, and best practices for medical device software development and market entry.

Whitepaper

Standards and regulations for software used in Medical Devices

Explore the essential standards and regulations for software used in Medical Devices, including IEC 62304 and IEC 82304. Download now.

Webinar

Setting up ATMP Quality Management Systems: Strategies for Compliance and Success

Discover strategies for establishing a compliant and successful ATMP Quality Management System. Watch our webinar on demand.

Webinar

Mastering Clinical Performance Studies under IVDR

In the evolving regulatory landscape of IVDs, demonstrating clinical performance is more crucial and challenging than ever. Discover more in this webinar on demand.

Webinar

The Basic Concepts of the QbD Methodology

Learn the basics of QbD methodology with industry experts in this on-demand webinar.

Whitepaper

Clinical evidence for In Vitro Diagnostics under IVDR

In this whitepaper, we will guide you through the documents required for the demonstration of clinical evidence under the IVDR. Download now.

Webinar

ATMP Supply Chain: Navigating the Challenges and Exploring the Vein-to-Vein Strategy

Explore the transformative ATMP journey and vein-to-vein strategy in our webinar. Learn how to navigate challenges and unlock the full potential of ATMPs.

Whitepaper

Achieving laboratory compliance

This whitepaper explores the multifaceted aspects of laboratory compliance, including data integrity, quality control measures, and regulatory adherence.

Whitepaper

Annual Product Quality Review in Pharma

Want to learn more about the importance, benefits, and key challenges related to the Annual Product Quality Review in Pharma? Then read on quickly!

Whitepaper

New GMP Facility Qualification: set-up, process and best practices

This whitepaper delves into the challenges of establishing a new GMP facility, focusing on potential pitfalls and best practices. Download now.

Whitepaper

The One-Vigilance strategic roadmap to corporate excellence

This whitepaper introduces the concept of One Vigilance within the context of the current drug safety landscape. Download now.

Case study

Guiding KU Leuven's glioblastoma research to the clinic with precision business planning

Helping KU Leuven advance glioblastoma research to the clinic with strategic business planning, funding support, and a roadmap for clinical impact.

Webinar

Post-Market Surveillance Requirements for Medical Devices and IVDs

Learn about post-market surveillance requirements under MDR and IVDR regulations. Gain insights from industry experts in this on-demand webinar.

Whitepaper

21 CFR Part 11 compliance checklist

Want to assess whether a computer system generates electronic records and uses electronic signatures, and whether the system complies with Part 11 of 21 CFR? Download this free checklist.

Whitepaper

Ensuring compliance and quality in Pharmacovigilance

The whitepaper emphasizes the importance of a robust pharmacovigilance QMS and a well-maintained Pharmacovigilance System Master File (PSMF). Download now.

Webinar

Second edition of GAMP 5: A Risk-Based Approach to compliant GxP Computerized Systems

This webinar on demand will tell you more about the second edition of GAMP 5.

Whitepaper

Organic and mutagenic impurities in pharma

Ensure pharmaceutical quality and safety by controlling organic and mutagenic impurities. Download this whitepaper to learn more.

Whitepaper

The key role of Regulatory Affairs in the pharmaceutical industry: from drug development to commercialization

Discover the key role of Regulatory Affairs in pharma and how Regulatory Affairs teams support product lifecycle management in this whitepaper. Download now.

Webinar

Verification & Validation of Artificial Intelligence/ Machine Learning Medical Devices

Explore the impact of Artificial Intelligence and Machine Learning on medical device validation and verification processes.

Whitepaper

GAMP categories for computerized systems: what are they and what are they for?

In this whitepaper, you will learn what GAMP is, what GAMP categories are for, and where to start if you are facing computerized systems validation.

Whitepaper

Analytical Method Validation

In this whitepaper, we will give an overview of the criteria to consider when validating your analytical method.

Whitepaper

EUDRALEX Volume 4 Annex 11 Compliance Checklist

Assess your computer system's compliance with EudraLex Volume 4 Annex 11 guidelines using our checklist. Download now for GMP assurance.

Webinar

3D Printing in the Healthcare World

Explore the challenges and opportunities of 3D printing in healthcare, featuring expert insights on regulations, pitfalls, and efficiency.

Whitepaper

From V-model to Agile: how to embrace automation as part of the computerized system validation approach

This white paper explores why IT is shifting to agile, focuses on the prevalent Scrum methodology, and concludes with guidance on adapting system validation processes.

Webinar

IVDR Extension Explained: Tips & Strategies

Gain valuable insights on the IVDR extension and its impact on IVD manufacturers with our webinar on demand.

Whitepaper

Innovations in ATMP: state of the industry in 2024

This whitepaper explores the innovations in ATMP and solutions in detail, with a focus on the current landscape as of April 2024. Download now.

Case study

Optimizing pharmacovigilance for a biotechnology leader

Discover how QbD Group improved pharmacovigilance for a global leader in biotechnology, ensuring regulatory compliance and patient safety.

Case study

Ensuring timely launch: QbD Group's role in establishing a hemophilia drug production line

QbD Group has facilitated the launch of a new drug production line for treating hemophilia, overseeing the qualification of over 100 pieces of small-scale supporting equipment.

Case study

Ensuring pharmaceutical production quality: cleaning validation for government agency

Discover how QbD Group helped a client tackle dual validation challenges for their production lines, ensuring GMP compliance and AEMPS approval.

Case study

Revolutionizing pharmacovigilance: a success story of strategic partnership and seamless integration

Discover how QbD Group's expert support enhanced a pharmaceutical company's pharmacovigilance, leading to a favorable inspection outcome by the local Regulatory Authority (AEMPS).

Case study

The journey toward IVDR compliance for the LVOne device

QbD Group helped Upfront Diagnostics gain entry into the MD/IVD industry by supporting them on their path to ISO 13485 certification.

Case study

Patient Support Program (PSP)

Learn about our patient support program (PSP) and how it helps manage customer support for a PV Spanish client. Resolve quality issues and ensure stability with QbD Pharma.

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.

Case study

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

QbD Clinical assisted Minze Health, a urology-focused medical devices company, in obtaining CE marking under MDR through clinical evaluation.

Webinar

The Medical Device CE Certification Pathway Explained: From Classification to Conformity Assessment by the Notified Body

Learn about the Medical Device CE Certification Pathway, from classification to conformity assessment by a Notified Body. Join our webinar on demand.

Case study

Helping Relu to comply with changing regulations

QbD Group supported software company Relu with their expertise to comply with changing regulations.

Case study

Helping Abraca BioSystems to obtain ISO 13485 certification

QbD Group helped Abraca Biosystem gain entry into the MD/IVD industry by supporting them on their path to ISO 13485 certification.

Case study

Help BioLizard build their Quality Management System

QbD Group helped BioLizard document the fundamental processes of their QMS and enabled them to continue building it on their own.

Case study

Supporting Oncomfort in developing and certifying their ISO 13485 QMS

QbD Group helped Oncomfort quickly implement and certify an ISO 13485 compliant Quality Management System.

Case study

Quickly bringing a new COVID-19 medical device to market

Obtaining the required government certifications for a medical device is always a challenge. Especially when the COVID clock is ticking.

Discover all

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QbD Group welcomes Diane Fairweather as Division Head Clinical

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QbD Group welcomes Dr. Diane Fairweather as Division Head...

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10 Feb 2025

Clinical Trial Operations

What?

How

Why QbD Group?

Question 1

Question 1

Question 1

Question 1

Lorem Ipsum

Resources

Validating a Complex Autoclave Load to Enhance Sterilization Efficiency

Fast-Tracked Site Qualification for Clinical Trial Submission

Pharmacovigilance and Risk Management in Innovative Therapies: A Challenge in Drug Safety

Extractables & Leachables in Pharma: Navigating Evolving Regulations and Toxicological Challenges

A Complete Guide to Computer System Validation

Digital Health - Exploring the landscape and future opportunities

ISO 13485:2016 - Compliance Checklist

Enhancing data integrity & aseptic manufacturing compliance

A Decade of Excellence: Linguistic Review Support for a Global Pharma Leader​

ICH Stability Studies on Pharmaceuticals

EU GMP: How to import your products into the EU?

Scalable MSAT validation support for seamless compliance & efficiency

Restoring manufacturing timelines through expert deviation management

Guiding a global biotech company through ATMP facility qualification

How to keep computerized systems in the operational phase

Medical Device Regulation (MDR) Checklist

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

Regulatory Affairs for Pharma and Biotech

From Requirements to Code: a unified MDSW development cycle that covers all requirements

Clinical Evaluation for Medical Devices under MDR

IVDR extension: what does this mean for you?

From Concept to Market: Comprehensive Market Access Strategies for Medical Device Software

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

Drug-Device Combination Products and Article 117

Mobile health on the rise: exploring the regulatory landscape for reimbursement

Clinical investigations under MDR: key insights and practical experiences

The pathway from idea to patient under MDR

Unlocking Strategic Value in Drug Safety for Life Sciences Organizations

CE Mark Renewal for bioXtra Products: A Success Story

Technical Documentation Essentials for Medical Device Software

GAMP 5 Software Validation Approach for GMP, GCP and GLP regulations

How to manage mandatory communication of Toxicological Risks?

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Standards and regulations for software used in Medical Devices

Setting up ATMP Quality Management Systems: Strategies for Compliance and Success

Mastering Clinical Performance Studies under IVDR

The Basic Concepts of the QbD Methodology

Clinical evidence for In Vitro Diagnostics under IVDR

ATMP Supply Chain: Navigating the Challenges and Exploring the Vein-to-Vein Strategy

Achieving laboratory compliance

Annual Product Quality Review in Pharma

New GMP Facility Qualification: set-up, process and best practices

The One-Vigilance strategic roadmap to corporate excellence

Guiding KU Leuven's glioblastoma research to the clinic with precision business planning

Post-Market Surveillance Requirements for Medical Devices and IVDs

21 CFR Part 11 compliance checklist

Ensuring compliance and quality in Pharmacovigilance

Second edition of GAMP 5: A Risk-Based Approach to compliant GxP Computerized Systems

Organic and mutagenic impurities in pharma

The key role of Regulatory Affairs in the pharmaceutical industry: from drug development to commercialization

Verification & Validation of Artificial Intelligence/ Machine Learning Medical Devices

GAMP categories for computerized systems: what are they and what are they for?

Analytical Method Validation

EUDRALEX Volume 4 Annex 11 Compliance Checklist

3D Printing in the Healthcare World

From V-model to Agile: how to embrace automation as part of the computerized system validation approach

IVDR Extension Explained: Tips & Strategies

Innovations in ATMP: state of the industry in 2024

Optimizing pharmacovigilance for a biotechnology leader

Ensuring timely launch: QbD Group's role in establishing a hemophilia drug production line

Ensuring pharmaceutical production quality: cleaning validation for government agency

Revolutionizing pharmacovigilance: a success story of strategic partnership and seamless integration

The journey toward IVDR compliance for the LVOne device

Patient Support Program (PSP)

Ensuring a smooth MDR transition for Oystershell's medical devices

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

The Medical Device CE Certification Pathway Explained: From Classification to Conformity Assessment by the Notified Body

Helping Relu to comply with changing regulations

Helping Abraca BioSystems to obtain ISO 13485 certification

Help BioLizard build their Quality Management System

A Decade of Excellence: Linguistic Review Support for a Global Pharma Leader