2k Clinical Consulting, Inc.

Inspection Readiness Outlook 2024: Navigating FDA Expectations in the Clinical Industry

As the clinical industry ventures into 2024, the landscape is increasingly shaped by the FDA’s evolving expectations. This year, a greater emphasis is placed on data integrity, technological integration, and the adaptation to new inspection models. In this context, insights from previous blogs such as “Why Quality is Everyone’s Business“, “Steps To Establishing a Quality Culture in Clinical Research“, and “How Changes in E6 (R3) of ICH GCP are Changing the Future of Clinical Trials” become particularly relevant.

  1. Emphasizing Quality as a Universal Responsibility

Echoing the sentiments of “Why Quality is Everyone’s Business“, it’s imperative to recognize that quality in clinical trials is not just the responsibility of the quality assurance team but of every individual involved. This collective approach ensures thorough preparation for FDA inspections and enhances overall trial integrity.

  1. Establishing a Quality Culture in Clinical Research

Drawing from “Steps To Establishing a Quality Culture in Clinical Research”, it is crucial for organizations to cultivate a culture where quality is ingrained in every process. This involves regular training, proactive risk management, and an environment that encourages transparency and continuous improvement. Such a culture not only aids in inspection readiness but also ensures adherence to the highest standards of clinical research.

  1. Adapting to Changes in ICH GCP Guidelines

The blog “How Changes in E6 (R3) of ICH GCP are Changing the Future of Clinical Trials” highlights the significant updates in the ICH GCP guidelines, especially E6 (R3). These changes, focusing on risk-based approaches and enhanced data integrity, have direct implications on inspection readiness. Organizations need to adapt their strategies and processes to align with these updated guidelines, ensuring compliance and readiness for FDA inspections.

  1. Integrating Technology and Data Management

With the FDA’s technology-driven approach, organizations must integrate advanced data management systems and adopt technologies like AI and blockchain for better traceability and security. This also includes ensuring that electronic health records (EHRs) and electronic data capture (EDC) systems are leveraged effectively for streamlined data collection and analysis.

  1. Remote and Hybrid Inspection Readiness

Adapting to remote and hybrid inspection models is essential. Organizations must ensure their digital infrastructure is secure, compliant, and capable of providing necessary documentation and data remotely.

  1. Global Regulatory Compliance

For organizations involved in international trials, understanding and adhering to global regulatory standards, including those set by the FDA, is crucial.

Conclusion

As the clinical industry progresses through 2024, a multifaceted approach to inspection readiness is key. Emphasizing quality as a collective responsibility, establishing a strong quality culture, adapting to changing guidelines, and leveraging technology are integral components of this strategy.

We Value Your Input:

How have the changes in ICH GCP guidelines impacted your organization’s approach to inspection readiness? Share your experiences and insights, and let’s discuss how these evolving standards are shaping the future of clinical trials.

Steps To Establishing a Quality Culture in Clinical Research

 

A quality culture pertains to the shared beliefs, values, and attitudes that incorporates a quality mindset which also influences the actions taken by individuals within an organization. It is essential to establish a quality culture in the workplace in clinical trials to ensure high-quality data is collected and patient safety is maintained.  Establishing a quality culture in clinical research is not just about having policies and procedures in place, it is also about ensuring that everyone follows them. This requires implementing several important steps.

Step One: Define quality expectations

The first step in establishing a quality culture is to identify the quality standards, processes, procedures, and timelines that must be followed to ensure high-quality research. It is required to develop clear expectations for data collection, monitoring, and reporting, as well as define requirements for maintaining compliance with regulatory requirements and industry standards. Make sure that everyone involved in the research understands what is expected of them in terms of quality and patient safety.

Step Two:  Develop quality metrics

The next step is to create a set of measurable indicators that can be used to monitor and evaluate the effectiveness of the quality management system. These metrics should be clearly defined and aligned with the organization’s quality expectations. Examples of quality metrics in clinical trials may include the number of protocol deviations, the percentage of completed monitoring visits, and the number of audit findings.

Step Three: Establish a quality management system

Establishing and implementing a clinical quality management system involves creating a set of policies, procedures, and practices that ensure that all processes are in place to achieve quality expectations. It is crucial to develop standard operating procedures (SOPs) for data collection, analysis, and reporting, as well as implement a training program to ensure that all staff members understand their roles and responsibilities and create a system for documentation and record-keeping.

Step Four:  Provide training and education

All staff members involved in clinical trials must be appropriately trained and educated on the importance of quality and patient safety. This includes providing training on the quality management system, relevant regulations, and the importance of patient safety. Training is essential for ensuring that everyone has the knowledge and skills needed to carry out their roles effectively. Provide regular training sessions to ensure that everyone is up to date on the latest procedures and regulations.

Step Five:  Promote effective communication

Effective communication is essential to ensure that everyone is aware of their responsibilities and can communicate openly. The training sessions, regular meetings, and feedback mechanisms are required to encourage everyone involved in the research to provide feedback on the quality culture and any issues or opportunities for improvement. This will help to identify areas that need to be addressed and provide opportunities to enhance the quality of the culture in the workplace.

Step Six:  Encourage continuous improvement

Monitor and evaluate the quality management system to identify areas for improvement. It involves conducting internal audits, analyzing quality metrics, and implementing corrective and preventive actions to address any deficiencies and continuously improve the quality management system. Recognize and reward individuals who demonstrate a commitment to quality culture. This could be in the form of bonuses, promotions, or other incentives.

Step Seven:  Demonstrate leadership commitment

Leaders within the organization should model the desired behavior by following the established policies and procedures. This will help to reinforce the importance of quality culture and inspire others to do the same. Ensure that leaders are committed to establishing and maintaining a quality culture in the workplace. Demonstrate leadership commitment by promoting and supporting a culture of quality and patient safety, providing the necessary resources and support to implement and maintain the quality management system.

Conclusion

 Incorporating a quality culture in the workplace not only increases compliance but also increases public trust in research while also advancing the field of clinical research with positive patient outcomes. If your department is looking for ways to establish or  strengthen the quality culture in the workplace, Contact us! We’d love to hear from you to discuss strategies!

How Changes in ICH E6 (R3) Guidelines are Changing the Future of Clinical Trials

ICH E6 (R3) Guidelines for Good Clinical Practices (GCP) have been a work in progress to put forward changes to the previous R2 version.  The overall purpose is to revise principles that account for ethical trial conduct, participant safety, and clinical trial outcomes that may be reliable. The ICH E6 R2 Guidelines for GCP consists of three key components:

  1. The overarching principle that will apply across the board
  2. Annex 1
  3. Annex 2

Annex 1 currently reflects the principles in E6 (R2), with necessary updates and modifications. While Annex 2 contains additional information that should be considered in the case of non-traditional interventional clinical studies that are not included in Annex 1.

Besides Annexes 1 and 2, the modifications in R3 consist of 12 major principles.  These 12 principles heavily focus on conducting clinical trials based on ethical principles, designing and conducting research that ensures patient rights, safety, and well-being.

Moreover, the principles highlight the need to acquire informed consent where participants are aware of all the trials. Subjecting the clinical trial to an objective review is another critical principle, along with ensuring that all trials adhere to the requirements based on the latest scientific knowledge.

Additionally, the principles highlight the importance of conducting the trial by an expert within the field and the necessity to include it in the scientific and operational design and execution of clinical trials. There is also an emphasis on designing the trial so that it’s comparative to patient risk and trial results while also ensuring that it’s clear and concise.

R2 vs. R3 What is The Difference?

R2

R3

Risk-based approach – The focus of E6 (R2) was on a balanced, risk-based approach to clinical trial design and execution.

Risk-based approach -ICH E6 R3 is intended to promote this notion while also encouraging interested parties to incorporate this approach.

Technology – E6 (R2) isn’t entirely equipped to deal with new technology.

Technology – The rising usage of electronic data sources and risk management procedures is addressed in E6 (R3).

Principle/Annex – R2 consisted of the overarching principle and annex 1.

Principle/Annex – R3 has revised the overarching principle and annex 1. Moreover, there is an addition of annex 2.

Is Clinical Research Industry Going to Face New Challenges?

Any change can bring about challenges; however, the gravity of the challenges depends on the quality design of the trial(s) currently in place. There is an evident need to ensure the reliability of clinical trial results. Without this, all the resources used to accomplish the findings would result in a loss of millions of dollars. This is precisely why the ICH E6 R3 has emphasized using Risk-Based Quality Management (RBQM) and Risk-Based Monitoring (RBM).

Many of the methods and technologies that researchers are already using in clinical trials will be simplified by the new ICH advice, especially when it comes to risk-based monitoring (RBM). The industry may anticipate guidelines on remote evaluation and observation, as well as a technical design that is flexible enough to accommodate both existing platforms and future developments, assuring trial integrity while removing the effort of confirming non-critical evidence.

Conclusion

Although many clinical researchers have yet to get accustomed to the ICH E6 R3 or implement it, the clinical importance of applying these guidelines will streamline research and produce more accurate and reliable results. Moreover, ICH E6 R3 will ensure inspection readiness ensuring no hindrance to clinical trials, which is why immediate implementation of ICH E6R3 guidelines are truly beneficial.

The process of building quality into the design of a trial can be arduous without the sound quality management system (QMS) in place.  Don’t have the time to ensure your system has the quality that exceeds compliance to the ICH E6 R3 standards?  Contact us and let us help you implement compliance strategies and a streamlined process for your QMS prior to the rollout! 

 

References

CITI Program. 2021. ICH Releases Draft Principles for GCP | CITI Program. [online] Available at: <https://about.citiprogram.org/blog/ich-releases-draft-principles-for-gcp/> [Accessed 15 March 2022].

ICH, 2019. Final Business Plan ICH E6(R3): Guideline for Good Clinical Practice. [online] Available at: <https://database.ich.org/sites/default/files/E6-R3_FinalBusinessPlan_2019_1117.pdf> [Accessed 15 March 2022].

ICH, 2021. ICH-E6 Good Clinical Practice (GCP). [online] Available at: <https://database.ich.org/sites/default/files/ICH_E6-R3_GCP-Principles_Draft_2021_0419.pdf> [Accessed 15 March 2022].

Mauri, K., 2021. Rewriting the Rules: How to Prepare for ICH E6 (R3). Pharmaceutical Outsourcing, [online] Available at: <https://www.pharmoutsourcing.com/Featured-Articles/579132-Rewriting-the-Rules-How-to-Prepare-for-ICH-E6-R3/> [Accessed 15 March 2022].

The Importance of a Clinical Quality Management System (CQMS)

There has never been a better time to be in clinical research. From constant scientific innovation to being a part of a community of academic experts, there are seemingly endless opportunities to grow. While it all might seem exciting from the outside, organizations still face some internal challenges.

One such obstacle is the current clinical quality management systems (CQMS) in place at many start-ups or small firms. Their QMS are often not in line with global regulatory authority regulations or are deficient in the level of documentation needed to reconstruct and defend every aspect of clinical trials.

This can be fixed by having the basic quality systems embraced at every level of the organization in order to set the foundation for internal compliance and vendor oversight. In this article, we’ll discuss in detail about what the CQMS is, its key elements, and why it is important to implement in your organization.

What is a Clinical QMS vs QMS?

Every organization has a blueprint by which it operates under called the “quality system”, also known as the “quality management system” (QMS). It is a dynamic mechanism that overlooks and aims to improve core processes at maximum efficiency. The goal of the QMS is to provide a high-quality product at the lowest cost. In action, the QMS implements specific concepts, standards, methodologies, and tools to achieve quality-related goals.

On the other hand, the CQMS is a quality system more specific for clinical research and study management. It helps manage documents, processes, quality events, audits, and many more activities that occur throughout a clinical trial. More specifically, this system facilitates activities across the Clinical Quality and Clinical Operations sectors to improve efficiency, promote risk mitigation and risk management practices, and expedite drug development and delivery.

Key Elements of a Clinical QMS: Quality Management System Solutions

When setting up and implementing a CQMS, these are the key elements that should be highlighted:

  • Any processes should be well-defined prior to documentation. The organization should then determine the level and detail of procedural documentation that is needed to describe these processes. Procedural documents should detail policies, standard operating procedures, working instructions, etc.
  • Resources, Roles and Responsibilities. Both material resources and staff should be described in this part of the CQMS. Staff members should have clear roles and responsibilities that will directly affect operations and quality of outcomes. Leadership should be proactively managing resources on a consistent basis.
  • This includes collaborations, such as joint product development or outsourced activities. An organization has to understand the needs, expectations, limitations, and risks that will be carried out in such partnerships.
  • Risk Management. While you cannot predict every scenario that will happen, a risk management process will allow an organization to better predict such situations and prioritize resources to address the most significant risks that do arise.
  • Issue Management. This type of framework gives an organization the ability to quickly identify, investigate, assess, elevate, and communicate significant issues. Ideally, it should work in a way that issues will not recur and continue to improve the quality of clinical studies.
  • Knowledge Management. Knowledge is critical to the success of an organization’s performance. A knowledge management framework allows information to be applied by employees faster.
  • Documentation Supporting Achievement of Quality. There should be an appropriate level of documentation to back up the risks and significance of a clinical trial activity that will satisfy quality objectives and stakeholder requirements.

Important Benefits of QMS

An effective QMS system will result in better outcomes across all areas of your organization. Some of the most important benefits of a QMS include:

  • Identifying and improving processes
  • Improving patient safety in clinical trials
  • Providing a consistent framework for regulatory authorities
  • Streamlining clinical trial processes
  • Assuring data integrity
  • Reducing delayed studies
  • Resolving repetitive quality issues
  • Lowering costs

Conclusion

One of the reasons why some organizations struggle to achieve quality results is because of the lack of a framework that could help them better guide their processes and performance. A CQMS empowers organizations to define, learn, and improve upon every aspect of their process not only to improve performance and outcomes, but to also meet different stakeholders’ expectations. Implementing a CQMS will enhance an organization’s performance and inspection readiness and will ultimately facilitate the approval of investigational products.