Clinical Safety Management

Protecting participants and meeting regulatory standards

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

At QbD Group, we’re dedicated to protecting participants and meeting the highest regulatory standards. Our services include adverse event review, regulatory reporting, CEC and DSMB management, and more.

How we can support you

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

Initial consultation

Assessing project scope and regulatory needs to design a customized approach.

Ongoing support

Continuous monitoring, documentation, and reporting upholding safety and compliance.

Timely risk management

Identifying and managing potential risks swiftly to protect participant safety.

Independent Committees (CEC/DSMB)

Establishing committees for safety monitoring, data integrity, interim analysis, and ethical oversight.

Why choose QbD Group?

With extensive experience in managing clinical safety, QbD Group is your trusted partner.

Regulatory compliance

Deep knowledge of EU MDR and national regulations.

Dedicated specialists

Hands-on support throughout pre- and post-market studies.

Tailored solutions

Customized services for every investigation phase.

Unbiased oversight

Independent oversight through CEC and DSMB services.

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 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.

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 CEC and DSMB management:

Set-up of the CEC and DSMB committee (selection and contact of members, set-up and collection of essential documents)
Creation of CEC and DSMB charter
Set-up and facilitating regular meetings
Source documentation collection and review
Safety package preparation

The independent committees ensure clinical investigations are conducted ethically and safely through: safety monitoring (DSMBs regularly review safety data), data integrity (ensuring data is reliable and adheres to protocol), interim analysis (evaluating effectiveness and making adjustments), ethical oversight (protecting participants' rights), and adverse event review (CECs evaluate adverse events and recommend actions).

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

Why QbD Group

Your trusted partner

Ensuring clinical investigations run safely, efficiently, and in full regulatory compliance.

Expertise in regulatory compliance.

Dedicated clinical safety specialists.

Tailored solutions.

Unbiased oversight.

Plan your clinical pathway

From gap assessment to full CRO delivery, our clinical experts are ready to support your MedTech journey.