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

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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.

Clinical Trial Trends in 2024: Innovations and Evolutions in Inspection-Readiness

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The year 2024 has brought significant innovations to the clinical trial sector, especially in terms of inspection-readiness. This article provides an overview of how these trends are influencing preparedness for regulatory inspections. For a deeper understanding of the importance of quality in this evolving landscape, read “Why Quality is Everyone’s Business“.

Technological Advancements in Inspection-Readiness

Technological integration is at the forefront of enhancing inspection-readiness. Digital documentation systems and AI-driven compliance tools are now vital in streamlining the inspection process. These technologies ensure continuous compliance and readiness, significantly reducing the risk of non-compliance during inspections. For practical insights into establishing an effective training program in this area, consider “Tips on Establishing an Inspection Readiness Training Program“.

Real-Time Data Monitoring

A notable trend is the adoption of real-time data monitoring systems. These systems provide ongoing oversight, immediately identifying and addressing areas of concern. This proactive approach ensures that trials maintain high standards of data integrity and regulatory compliance.

Decentralized Trials: Challenges and Solutions

The rise of Decentralized Clinical Trials (DCTs) poses unique inspection-readiness challenges. The article discusses strategies to ensure DCTs maintain the same level of regulatory compliance as traditional trials, focusing on remote monitoring and digital data validation methods.

Evolving Regulatory Expectations

Regulatory bodies are continuously evolving their expectations in response to these technological advancements re-shaping the future of clinical trial inspections.

Adapting to New Standards

Pharmaceutical companies and CROs are adapting their strategies to meet these new standards. Emphasis is placed on training, technology integration, and developing robust internal audit systems to ensure continuous inspection readiness. Explore the importance of establishing a quality culture in this context through “The Benefits of Establishing a Quality Culture In Clinical Operations“.

In conclusion, 2024 has marked a pivotal year in reshaping how clinical trials prepare for inspections. The trends discussed here highlight the industry’s move towards more efficient, technology-driven approaches to meet evolving regulatory standards.

Your Opinion Matters

What do you think will be the next big innovation in clinical trial inspection-readiness?

 

 

 

Why Quality is Everyone’s Business

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World Quality Day, celebrated on a global scale every year on the second Thursday in November, serves as a reminder that quality is not just a buzzword or a department in your organization—it’s everyone’s business. Whether you work in clinical operations, healthcare, manufacturing, or any other industry, ensuring quality should be a shared responsibility. In this blog post, we’ll explore why quality is crucial, how it impacts various aspects of your business, and why fostering a culture of quality is essential for long-term success. 

Quality Breeds Trust

Quality is the cornerstone of trust. When you consistently deliver high-quality products or services, your customers and clients develop trust in your brand. Trust is not just important for customer satisfaction but also for building lasting relationships. In clinical operations, trust is paramount, as patients rely on healthcare professionals to provide accurate diagnoses and effective treatments. The link between trust and quality is evident, making it clear that quality is everyone’s responsibility.

Quality Enhances Efficiency

Poor quality can lead to inefficiencies, causing wasted time and resources. When a product or service lacks quality, it often requires rework, leading to increased costs and delays. By prioritizing quality, each team member can contribute to streamlined processes, reducing errors, and boosting productivity. In clinical operations, efficiency can save lives, making the pursuit of quality a shared mission.

Quality Reduces Risk

Quality control and risk management go hand in hand. Ensuring high-quality products or services minimizes the potential for defects, recalls, or adverse events. In clinical operations, such as drug development, the consequences of poor quality can be catastrophic. By making quality everyone’s business, organizations can proactively identify and mitigate risks, safeguarding the well-being of patients and the reputation of the company.

Quality Drives Innovation

Innovation and quality are interconnected. When every team member is committed to delivering high-quality results, they’re more likely to seek creative solutions and improvements. Quality-driven innovation can lead to better products, services, and processes, setting your organization apart from the competition. In clinical operations, innovation can lead to groundbreaking treatments and advancements in patient care.

Quality Fosters a Culture of Excellence

A culture of quality doesn’t happen by chance; it’s a result of collective effort. When quality is everyone’s business, it becomes a part of your organization’s DNA. This shared commitment to excellence encourages employees to take pride in their work and continuously strive for improvement. In clinical operations, a culture of quality can save lives and contribute to the development of groundbreaking treatments.

In conclusion, quality is not a solitary responsibility but a collective one. From the boardroom to the front lines, everyone plays a vital role in ensuring quality. By fostering a culture where quality is valued and upheld by all, organizations can build trust, enhance efficiency, reduce risk, drive innovation, and ultimately achieve long-term success.

Now that we’ve established that quality is everyone’s business, it’s time to take action. The success of your clinical operations depends on a collective commitment to quality. As we acknowledge WORLD QUALITY DAY, let’s make a collaborative effort to act on the principles discussed in this article. Implement a culture of quality within your clinical operations. Start discussions within your team, set quality benchmarks, and continuously strive to exceed them. Remember, quality is not a destination but a journey, and it’s a journey that’s everyone’s business.

Together, we can build a future where the quality of our work is synonymous with the quality of life for countless patients. It’s a journey worth taking, and it starts with you.

Take the First Step towards Quality Excellence

Quality is not a department. It’s not a job title. It’s a mindset, a commitment, and a culture. Make it everyone’s business, and you’ll be one step closer to achieving excellence in clinical operations. So, let’s celebrate World Quality Day by embracing quality as everyone’s business, and don’t forget to join our mailing list and subscribe to our newsletter for regular quality insights and updates.

Steps To Establishing a Quality Culture in Clinical Research

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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!

The Benefits of Establishing a Quality Culture In Clinical Operations

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Imagine this…you are recently hired as a Quality Associate to assist in improving inspection-readiness in the clinical operations department.  You immediately realize the following based on your observations:

  1. You are not formally introduced to the organization’s quality vision and values at your orientation session.
  2. Your mandatory training and development courses do not include or emphasize the importance of quality.
  3. The implementation of quality is rarely mentioned in the discussion of department metrics and goals.

These are warning signs of a weak quality culture within the department and minimal involvement of the quality assurance department in organization overall. 

Consequences of a weak quality culture

Quality culture in clinical research refers to an organizational mindset and set of practices that prioritize the quality and integrity of research data and the safety and well-being of study participants. Failure to establish a strong and robust quality culture in clinical research results in the following:

    • A greater risk of errors leading to serious adverse events or even death in extreme cases which can damage the reputation of the organization.

    • A trend of noncompliance with regulations which can produce poor quality data that hinders reliable conclusions from the research.

    • Poor quality control which may also result in delays and additional costs associated with correcting errors and addressing issues that arise during the research.

The benefits of establishing a quality culture

Establishing a quality culture in the workplace produces the desired clinical outcomes of clinical trials and also provides additional benefits such as:

    1. Assurance of patient safety – as clinical research involves human subjects who may be vulnerable and require protection from harm. A strong quality culture promotes adherence to strict ethical and regulatory standards, ensuring that the highest level of care and safety is provided to patients.

    1. Provision of high-quality data that is reliable and trustworthy -A quality culture ensures that data is collected, managed, and analyzed with accuracy and consistency, which enhances the credibility of the research and increases its value for future research and healthcare decision-making.

    1. Promotion of compliance to regulatory GCP requirements and standards – Compliance with these standards is necessary to gain approval for the research and to ensure that the results are acceptable for regulatory purposes.

    1. Protection of the organization’s reputation – Poor quality research can damage the reputation of the organization and undermine public trust in the research and healthcare industries.

    1. Cost reduction – Costs associated with correcting errors and addressing issues that arise during the research can be substantial. A quality culture ensures that issues are identified and addressed early on, minimizing the risk of costly mistakes and delays.

Conclusion

Establishing a quality culture promotes adherence to strict ethical and regulatory standards, ensures the collection and management of accurate and consistent data, and enhances the credibility of the research.. In addition, a quality culture helps to reduce the risk of costly mistakes and delays while protecting the organization’s reputation.  If your department is looking for ways to strengthen the quality culture in the workplace,  Contact us! We’d love to hear from you to discuss strategies!

5 Reasons Why QA Is Essential in Clinical Trials

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The coordinated and impartial review of all clinical trial-related activities and records is known as quality assurance. In the case of a clinical study, the quality assurance department has a wide range of responsibilities. Quality Assurance (QA) departments frequently aid in inspection readiness by establishing investigator site selection guidelines and identifying service providers to be audited, such as laboratories, packaging and supply chain vendors.

The Ongoing Challenge

The continuous monitoring of data collection processes and data management policies at every level of the study is an ongoing challenge in managing the quality of clinical data and maintaining compliance. This includes the following:

  • verifying that the data collected during the trial is consistent with the procedure (case report form [CRF] vs. protocol)
  • ensuring the validity of the data in the CRF and data acquired in source documents (CRF vs. source documents)
  • guaranteeing that the analyzed data correspond to the CRF data (database vs. CRF)

This confirms the need for QA involvement in clinical trials specifically in terms of inspection readiness.

Reasons Why Quality Assurance (QA) is essential

  1. Time Saver

While continuous monitoring during a clinical trial is a taxing task, it can save you from wasting hundreds of hours rectifying shortcomings within the trials at a later stage. Errors recognized in their initial stages are easier to modify to achieve desired outcomes. Whereas, delays can worsen the problem in clinical trials and inevitably push back the desired result, which can hinder the inspection readiness process.

  1. Money Saver

While many believe that investing in quality assurance from the get-go is not only time-consuming and costly, it is quite the opposite. Errors during the trial stage lead to millions of dollars lost during the production stage and major delays in inspection readiness, which can further add to the cost. Sometimes dropping the trial before entering the production stage due to a lack of quality assurance become inevitable.

  1. Boosts Client Confidence

Businesses that are known to ensure quality assurance are more likely to retain trust and confidence from clients and customers alike. During clinical trials, clients are more likely to follow the lead and trust the process when their standards of expectations align with the trials working. When boosting clients’ confidence, it is essential to highlight both the “whats” and “hows” of the trial, and quality assurance helps deliver the “hows” of the trial to keep your clients’ mind at ease.

  1. The Backbone of Consistency

When it comes to clinical trials, it is of utmost importance that each drug produced be of the same quality to prevent ill-desired outcomes. In clinical research, the quality assurance process ensures internal consistency by scheduling regular operational checks at each level of the trial process and data collection processing to validate trial procedure compliance and data validity.

  1. Leads to Accountability

When quality assurance is the working foundation of a clinical trial, each individual involved plays a vital role in ensuring that they deliver top-notch results in making the trial a success. Hence, the need for excellence permeates every aspect of a company in which quality assurance is at play.

Conclusion

Maintaining integrity and precision during a clinical trial is an ongoing, dynamic process that is the key to inspection readiness. This continuing process necessitates modifying processes and effectively conveying these adjustments to all investigators and support staff. This is why quality assurance involvement is essential and a key component to the clinical Quality Management System (cQMS) overall.

Need to strengthen or supplement your QA component? Contact us for a free consultation! We would love to hear from you to discuss strategies!

 

References

  • BROWN, C., 2019. Price Check: How to Cut Costs in Clinical Trials. [online] Anjusoftware.com. Available at: <https://www.anjusoftware.com/about/all-news/insights/cut-costs-clinical-trials> [Accessed 8 April 2022].
  • JLI Blog | Global Training & Education Provider. 2018. Quality Control and Quality Assurance in Clinical Trial | James Lind Blog. [online] Available at: <https://www.jliedu.com/blog/clinical-trial-quality-control-assurance/#:~:text=In%20clinical%20research%2C%20quality%20control,and%20reliability%20of%20the%20data.> [Accessed 8 April 2022].
  • Manghani, K., 2011. Quality assurance: Importance of systems and standard operating procedures. Perspectives in Clinical Research, 2(1), p.34.
  • Parashar, P., 1995. Patient Satisfaction – A valid tool of quality assurance (C. Q. I). J Family Community Med, 2(2), pp.7-8.
  • The Important Site. 2022. 10 Reasons Why Quality Assurance Is Important – The Important Site. [online] Available at: <https://theimportantsite.com/10-reasons-why-quality-assurance-is-important/#:~:text=Quality%20assurance%20is%20a%20process%20all%20organizations%20should,who%20could%20be%20with%20the%20company%20or%20independent.> [Accessed 8 April 2022].
  • Valania, M., 2006. Quality Control and Assurance in Clinical Research. [online] Applied Clinical Trials Online. Available at: <https://www.appliedclinicaltrialsonline.com/view/quality-control-and-assurance-clinical-research> [Accessed 8 April 2022].
  • WCG Avoca. n.d. Inspection Readiness: What is it and how do we get there?. [online] Available at: <https://www.theavocagroup.com/inspection-readiness-what-is-it-and-how-do-we-get-there/> [Accessed 8 April 2022].

The Importance of a Clinical Quality Management System (CQMS)

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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.

 

Our Mission and Purpose

The mission of 2K Clinical Consulting, Inc. is to ease the burden of GxP compliance and to transform the effectiveness of professionals and compliance systems worldwide.

Our History

2K Clinical Consulting, Inc. is the vision of former FDA Investigator, Kimberly Kiner, who empathized with facilities and sites that struggled with understanding and complying with regulations. After years in the field, Kimberly transitioned into the private sector and acquired international experience in compliance, monitoring and study management while she worked for pharmaceutical and invitro/medical device companies as well as CROs. This work experience is what sparked her desire to work as a consultant for organizations such as the Association for Clinical Research Professionals and the Society of Clinical Research Associates. Kimberly later went on to train providers such as Compliance Online and Fx Conferences. This exposure became the gateway to connecting with other experts and teaching professionals resulting in an engaging experience for clients that closes the gap in best practices within the realm of compliance.