Quality by Design: Risk-Based Approach to Clinical Trials

Internet gamblingLast week, ARITHMOS attended the GIQAR conference in Italy which focused on managing changes to GxP guidelines. ARITHMOS’ Stefano Piccoli presented at the conference on the topic of Quality by Design and how to prevent failure in monitoring by anticipating and mitigating risk when it comes to technology solutions.

The overall problem is that current practices in clinical research are not proportionate to risk or well-adapted to achieving the desired goals. Some origins of this problem include:

  • The costs of clinical development
  • Globalization of clinical trials which complicates the regulatory and business environments
  • Risk Aversion
  • Poor study design and processes
  • Failing to identify the individual implementation needs of quality control activities

The goal of Quality by Design is to build in quality prospectively rather than “test it in” retrospectively. This means identifying in advance the risks to quality and planning how to avoid them.

In terms of Quality Risk Management, the FDA is expecting a shift from data-heavy NDA/BLA submissions to “knowledge-rich” submissions with insight from QRM practices. Likewise, the EU expects risks to be identified prospectively and concepts to be applied at the early program design stage before individual trials are running.

How can Quality by Design help in clinical drug development?

  • Designing optimal infrastructure
  • Optimizing processes and systems
  • Mitigating risks associated with clinical programs and individual studies
  • “Fit-for-purpose” monitoring
  • “Fit-for-purpose” training and communication
  • Enhancing GCP compliance and reducing audit/inspection findings
  • Meeting health authority expectations
  • Reducing the likelihood of costly errors
  • Getting it right the first time and avoiding the need to “fix” it down the road

Risk Based Approach to CSV

Computerized systems that support GxP processes must be validated in proportion to the level of risk they present to patient safety, product quality and the integrity of regulated records. The validation effort should be concentrated on the areas with the most risk.

There are 5 steps to a Quality Risk Management process which is designed to scaled according to the level of risk, complexity and characteristics of individual systems.

  • Step 1: Perform Initial Risk Assessment and Determine System Impact
  • Step 2: Identify Functions with Impact on Patient Safety, Product Quality, and Data Integrity
  • Step 3: Perform Functional Risk Assessments and Identify Controls
  • Step 4: Implement and Verify Appropriate Controls
  • Step 5: Review Risks and Monitor Controls

ARITHMOS’ team of expert CSV and Life Sciences Application consultants, certified in COBIT 5 and ITIL, provide two approaches to Computer System Validation. The strategic approach involves appropriate expert planning, risk assessment, business process analysis and defining user requirements. In the maintenance approach, on-going project management and periodic compliance reviews ensure technologies are safe and accurate for end users through a continuously documented process. 

To schedule a pre-assessment meeting with one of our experts, contact us at info@arithmostech.com.



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