Clinical Safety Management

Managing clinical investigations requires more than precise planning—it’s about placing safety and compliance at the heart of every decision.

At QbD Group, we’re dedicated to protecting participants and meeting the highest regulatory standards. With our expert guidance and safety management solutions, we’ll support your clinical investigations every step of the way.

What is clinical safety management?

Clinical Safety Management encompasses the processes and practices that ensure the safety, integrity, and ethical conduct of clinical investigations.

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Clinical safety reporting in EU for medical device studies

We manage safety reporting for medical device studies, ensuring that the necessary safety data is communicated to the Competent Authorities (CA) and Ethical Committees (EC) as outlined in the European Medical Device Regulation (EU MDR) and national regulations. This includes:

Safety Management Plan (SMP) creation: tailored safety plans for investigations, covering procedures for monitoring, reporting, and management of adverse events.
Adverse event collection & review: implementing systems for timely collection, documentation, and classification of adverse events.
Safety monitoring & oversight: providing ongoing monitoring and oversight of safety data throughout the study.
Regulatory compliance: ensuring adherence to EU MDR, and national and local site requirements in safety reporting.
Periodic reporting: creation and submission of periodic safety progress reports, data listings, narratives, and other safety-related information.
Training & education: offering safety reporting training for clinical investigation staff.
Clinical expert services: providing Clinical Safety Specialists to support your team. Discover more here.

Learn how we can support you

Clinical event committees and data and safety monitoring boards

The establishment of independent committees like a CEC or a DSMB is applicable to all organizations conducting clinical trials across various therapeutic areas. Regulatory agencies such as FDA and EMA often require the implementation of such bodies to ensure safety, integrity and ethical conduct of clinical investigations.

QbD Group offers complete services for Clinical Event Committee (CEC) and Data and Safety Monitoring Board (DSMB) Management:

Set-up of the CEC and DSMB committee (selection and contact of members, set-up and collection of essential documents e.g. confidentiality agreements, conflict of interest statement, contract,…)
Creation of CEC and DSMB charter
Set-up and facilitating regular meetings
Source documentation collection and review
Safety package preparation

Discover how we can support you every step of the way

How we can support you

Clinical safety reporting

We help Medical Device Manufacturers seeking assistance with safety management of their pre-market as well as post-market medical device studies.

Initial consultation: We assess the scope of your clinical project, current progress, and regulatory needs to design a customized approach.
Ongoing support: Our team provides continuous monitoring, documentation, and reporting, ensuring that safety and regulatory compliance are consistently upheld throughout the study.
Timely risk management: We identify and manage potential risks swiftly to protect the safety and well-being of participants.

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Clinical Event Committees (CECs) and Data and Safety Monitoring Boards (DSMBs) Management

The independent committees that we can establish for you ensure that clinical investigations are conducted ethically and safely:

Safety monitoring: DSMBs regularly review safety data to assess participant safety and ensure that any risks are managed appropriately.
Data integrity: DSMBs also ensure that the data collected is reliable, adhering to protocol and regulatory standards.
Interim analysis: DSMBs conduct interim analyses of the study's data to evaluate the intervention’s effectiveness and make necessary adjustments or halt the study if required.
Ethical oversight: Both DSMBs and CECs provide ethical oversight, protecting participants' rights and welfare.
Adverse event review: CECs evaluate adverse events to determine whether they are related to the investigational product and recommend appropriate actions.

Did you know that outsourcing the CEC and DSMB management in your studies is cost-effective compared to maintaining in-house resources?

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Why choose QbD Group?

With extensive experience in managing clinical safety, QbD Group is your trusted partner in ensuring clinical investigations run safely, efficiently, and in full regulatory compliance. And this is why:

Expertise in regulatory compliance: deep knowledge of EU MDR, national regulations, and best practices, ensuring your study remains compliant at every stage.
Dedicated clinical safety specialists: our team provides hands-on support throughout your pre-market and post-market medical device studies.
Tailored solutions: we offer customized services for every clinical investigation phase, ensuring your specific needs are met.
Unbiased oversight: independent and impartial oversight through our CEC and DSMB services ensures the integrity and safety of your investigation.

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

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

Clinical Safety Management

What is clinical safety management?

What we offer

Clinical safety reporting in EU for medical device studies

Clinical event committees and data and safety monitoring boards

Clinical safety reporting in EU for medical device studies

Clinical event committees and data and safety monitoring boards

How we can support you

Why choose QbD Group?

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

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