Clinical Safety Management

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.

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.

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.

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).