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Enhancing Compliance: Aligning Vendor Practices with FDA Requirements 

In the rapidly evolving landscape of healthcare and pharmaceuticals, sponsor companies face the critical challenge of ensuring that their vendor practices align seamlessly with FDA requirements. This alignment is not just a regulatory mandate but a cornerstone for maintaining trust, ensuring product safety, and fostering innovation. By delving into the strategies for achieving this alignment, companies can navigate the complexities of compliance while sustaining growth and market reputation. 

Understanding FDA Requirements – The first step toward alignment is a thorough understanding of FDA regulations, which encompass a wide array of areas including product development, clinical trials, manufacturing, and post-market surveillance. These regulations are designed to ensure that products are safe, effective, and of high quality. For sponsor companies, this means ensuring that every vendor, from raw material suppliers to contract research organizations, adheres to these stringent standards. 

Strategic Vendor Selection – The cornerstone of compliance is the meticulous selection of vendors. Sponsor companies must conduct due diligence to assess a vendor’s capability to meet FDA requirements. This includes evaluating their quality control systems, regulatory history, and operational capacity. By choosing vendors with a robust track record of compliance, companies can mitigate risks and foster a culture of quality and reliability. 

Fostering Collaboration and Transparency – Building a transparent and collaborative relationship with vendors is crucial for compliance. This involves clear communication of expectations, regular audits, and continuous feedback mechanisms. By fostering an environment where information and best practices are shared openly, sponsor companies and vendors can work together to identify potential compliance issues and implement corrective actions proactively. 

Implementing Robust Monitoring and Auditing – Ongoing monitoring and auditing of vendor practices are essential to ensure continuous alignment with FDA requirements. This includes regular inspections, performance reviews, and the tracking of compliance metrics. By establishing a systematic approach to monitoring, sponsor companies can promptly address any deviations and implement improvements, thereby minimizing compliance risks. 

Leveraging Technology for Compliance – In today’s digital age, leveraging technology can significantly enhance compliance efforts. Advanced software solutions can streamline compliance monitoring, facilitate data sharing between sponsors and vendors, and provide real-time insights into vendor performance. By harnessing technology, sponsor companies can achieve greater visibility and control over their supply chain, ensuring that every link aligns with FDA standards. 

In conclusion, aligning vendor practices with FDA requirements is a dynamic and ongoing process that demands diligence, collaboration, and innovation. By understanding the regulatory landscape, selecting the right partners, fostering transparency, and leveraging technology, sponsor companies can establish a robust compliance framework. This not only safeguards product integrity and patient safety but also enhances the company’s reputation and market success. 

Your Feedback Matters How is your organization aligning vendor practices with FDA requirements? Are there specific challenges or success stories you would like to share? Your insights are invaluable, and we invite you to share your experiences and feedback to foster a collaborative learning community. 

By engaging with these strategies and sharing insights, sponsor companies can not only comply with regulatory mandates but also pave the way for a future where safety, quality, and innovation go hand in hand. 

Mastering Inspection Readiness: A Strategic Approach

In the constantly shifting terrain of regulatory compliance, mastering inspection readiness is more crucial than ever. Central to this challenge is developing and implementing a robust Inspection Readiness Plan (IRP). This plan isn’t just a procedural necessity; it’s a strategic asset aligning resources, processes, and teams toward ensuring successful regulatory adherence.

Strategic Inspection Readiness Planning
• Blueprint for Success: An IRP serves as a comprehensive framework, not just a checklist. It outlines the inspection’s scope, identifies key focus areas, and sets clear objectives. The plan is a navigational tool guiding teams through compliance complexities, addressing potential challenges proactively.
• Resource Alignment: It strategically aligns an organization’s resources, ensuring that all elements work in harmony towards the common goal of compliance.

Collaborative Execution
• Unified Efforts: The effectiveness of an IRP hinges on collaboration across various departments. Each department contributes its expertise, ensuring comprehensive compliance coverage.
• Responsibility Sharing: This collaborative approach evenly distributes responsibilities and fosters a unified response strategy.

Data Management and Transparency
• Clear Data Insights: At the heart of the IRP is data management. Organized and accessible data is vital for setting accurate inspection criteria, identifying compliance gaps, and implementing corrective actions.
• Informed Decision Making: Effective data management provides a transparent view of the organization’s compliance status, enabling informed and timely decisions.

Digital Tools: Enhancing Efficiency
• Streamlining Processes: Integrating digital tools into the IRP enhances its efficiency. These tools aid in data collection, document management, and real-time compliance monitoring.
• Reducing Error: Digital tools simplify complex processes, minimize manual errors, and ensure that compliance information is readily accessible.

Constant State of Readiness
Dynamic Adaptability: A well-executed IRP maintains an organization in a constant state of readiness, prepared for both scheduled and unexpected inspections. The plan should be flexible, reflecting the latest regulatory requirements and industry best practices.

Continuous Improvement Cycle
• Learning and Adapting: The IRP is part of a continuous improvement cycle, learning from each inspection and adapting processes    accordingly.
• Staying Ahead: This approach ensures that the organization stays ahead of regulatory changes and incorporates lessons learned into future readiness strategies.

Cultivating a Culture of Compliance
• Excellence and Quality: An effective IRP fosters a culture where quality and compliance are integral to every process and decision.
• Community Engagement: How is your organization nurturing this culture of excellence and compliance?

Conclusion: Your Role in Shaping Compliance
As we navigate the future of regulatory compliance, the significance of a well-crafted IRP is undeniable. It symbolizes a commitment to excellence, quality, and adaptability. Your experiences and insights are pivotal in enriching this dialogue and fostering a culture of shared learning and continuous improvement.


Join the conversation on how to master the art of inspection readiness. Your perspectives are key in shaping effective compliance strategies and navigating the future of regulatory compliance. For further insights, explore our related article on “Why Quality is Everyone’s Business.”

A New Era: AI, Decentralized Trials, and Regulatory Compliance

In this article, we delve into the intricacies of the evolving landscape of clinical research in 2024 with Artificial Intelligence (AI), Decentralized Clinical Trials (DCTs), and regulatory compliance.

The AI Revolution in Clinical Research
Artificial Intelligence (AI) is no longer just a buzzword in the realm of clinical research; it’s a reality reshaping our approach towards drug discovery and development. The integration of AI in this field has brought about unprecedented efficiency and precision. AI’s capability to analyze vast datasets is not only accelerating the process of identifying potential drug candidates but also ensuring that these candidates are more tailored and effective.

This technological advancement extends beyond just drug discovery. AI is revolutionizing manufacturing processes, enabling us to monitor and analyze extensive datasets. This oversight is crucial in enhancing production procedures, minimizing waste, and upholding rigorous quality control standards. The result? A more efficient, cost-effective, and quality-driven manufacturing process.

Decentralized Trials: A Patient-Centric Approach
Decentralized Trials (DCTs) are another pivotal trend in 2024. By shifting clinical trials from traditional, centralized locations to virtual or remote environments, DCTs are making clinical research more accessible and inclusive.

This shift is crucial in addressing the historical challenges of patient recruitment and retention. DCTs allow for broader demographic participation, offering insights into diverse patient experiences and responses to treatments.

However, the rise of DCTs also brings forth new challenges. Ensuring data integrity, managing patient privacy, and maintaining rigorous regulatory compliance in a decentralized setting require innovative solutions and strategic foresight.

Regulatory Compliance: A Moving Target
In this rapidly evolving environment, regulatory compliance remains a critical focus. The landscape is shifting, with regulatory bodies like the FDA placing greater emphasis on data integrity, sponsor oversight, and risk management. It is more important than ever for organizations to stay abreast of regulatory changes and ensure compliance.

The focus is not just on meeting current standards but anticipating future regulations. Engaging with Quality Assurance (QA) teams and leveraging their expertise in mock inspections and preparation can be a game-changer. Organizations must also be proactive in understanding and implementing the latest guidelines to maintain inspection readiness.

The Road Ahead
As we move forward in 2024, the clinical research landscape will continue to evolve. The integration of AI and the rise of DCTs are just the tip of the iceberg. We’re heading towards a more patient-centric, data-driven, and efficient era of clinical research.

But this journey is not without its challenges. Balancing technological advancement with ethical considerations, data integrity, and regulatory compliance is key. It’s an exciting time to be part of this industry, and we’re here to navigate these changes together.

Your Role in Shaping the Future
As valued members of our community, your insights and experiences are crucial in shaping the future of clinical research. We encourage you to engage with these topics, share your perspectives, and be a part of the conversation.

Together, let’s redefine the boundaries of clinical research and usher in a new era of innovation and excellence.

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.

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

 

As we navigate through the new year of 2024, the clinical trial landscape is experiencing transformative changes, particularly in the aspect of inspection-readiness. This abbreviated article provides a focused look into how these changes are influencing trial preparedness for regulatory inspections.

  1. Advancements in Inspection-Readiness The integration of new technologies and methodologies has brought about a significant shift in how clinical trials prepare for inspections. Innovations such as digital documentation systems and AI-driven compliance tools are streamlining the process, ensuring trials are always inspection-ready.
  2. Real-Time Data Monitoring The adoption of real-time data monitoring systems is a game-changer. These systems provide continuous oversight of trial data, flagging inconsistencies and areas of concern well before an inspection, thus reducing the risk of non-compliance.
  3. Decentralized Trials and Inspection Challenges Decentralized clinical trials (DCTs), while offering numerous benefits, also present unique challenges in maintaining inspection-readiness. Our article discusses strategies to overcome these challenges, ensuring DCTs adhere to regulatory standards effectively.

Conclusion The full article, accessible to our subscribers, delves deeper into how these trends are reshaping inspection-readiness in clinical trials and explores the evolving regulatory expectations and how companies are adapting to meet these new standards.  🔗 Subscribe now for full access to in-depth insights.

Your Insight Counts How do you think technology will further impact inspection-readiness in clinical trials beyond 2024?  Let us know in the comments section.  We look forward to hearing from you!

Tips on Establishing an Inspection Readiness Training Program

The task of documenting and maintaining records can prove to be a daunting one in the world of clinical research.  Effective resource allocation constitutes a delicate equilibrium. Striking the right balance between dedicating resources to training and compliance initiatives while judiciously managing costs becomes an intricate endeavor for organizations. It is critical to be attentive to resource needs in addition to ensuring that employees receive comprehensive inspection-readiness training in preparation for health authority inspections.  The do’s and don’ts of inspection readiness training that contributes to readiness success includes the following:

Do:

  1. Consistent Training Plan – Establish a regular schedule for training sessions, ensuring that all team members acquire a comprehensive understanding of health authority regulations and adherence to documented standard operation procedures.
  2. Exemplary documentation standards – Stress the importance of meticulous and comprehensive documentation. Implement and practice the most effective methods for maintaining impeccable records.
  3. Comprehensive cross-training – Promote cross-functional training initiatives aimed at nurturing a corporate culture deeply ingrained in compliance across various departments within your organization’s structure.
  4. Realistic scenario simulations – Create mock inspection scenarios that closely resemble real-world situations. This valuable exercise will help identify weaknesses and areas in need of improvement.
  5. Proactive regulatory awareness – Continuously monitor and stay informed about regulatory updates, adjusting your training programs to align with these evolving regulations.

Don’t:

  1. Discount the gravity of compliance – Never underestimate the gravity of aligning with regulations. Forgoing due diligence or shortcutting compliance requirements can result in grievous regulatory issues.
  2. Neglect training documentation – Never depreciate the importance of documenting training, both in terms of accuracy and completeness. Neglecting to properly oversee and document training can furnish a breeding ground for critical compliance and data discrepancies.
  3. Neglect post-training reinforcement – The failure to revisit training and scrutinize employee compliance can vitiate the efficacy of the training initiative. Assure that senior leadership exudes unwavering commitment to the training program.
  4. Defer compliance or cultivate a culture of blame – Do not defer the serious consideration of compliance until impending regulatory inspections materialize. Shun the cultivation of a culture that lays blame upon employees who are may not be main contributors to the errors or data discrepancies.
  5. Underestimate resource allocation – Do not underestimate the resource allocation requirements for the efficacious execution of training and compliance endeavors. Insufficient resource allotment can enervate the quality of training and impede compliance endeavors.

In conclusion, maintaining inspection readiness is a continuous process that demands diligence, commitment, and a robust training program. The challenges posed by evolving regulations and complex documentation can be overcome by following the dos and don’ts outlined above. By investing in comprehensive inspection readiness training program, organizations can safeguard their reputation, product quality, and, most importantly, patient safety in an ever-evolving regulatory landscape.

If you need to develop an inspection-readiness training program and need assistance, Contact us for a free consultation! We would love to hear from you to discuss strategies!

Inspection Readiness Checklists: 

The Benefits & How to Utilize Them

Checklists are invaluable tools in Inspection Readiness programs within regulated industry of pharmaceutical, medical device and biotech companies. They provide a structured approach to ensure that all necessary preparations are made for inspections, audits, and regulatory assessments. The importance of checklists in Inspection Readiness cannot be overstated, as they help organizations mitigate risks, and ensure the quality and safety of their products or services.  They also help with:

  1. Standardization: They create a consistent framework for preparing for different types of inspections, promoting a structured approach to compliance.
  2. Accountability: Checklists assign tasks and responsibilities to individuals or teams, reducing the likelihood of oversights or delays.
  3. Training and Awareness: They educate employees about regulatory requirements and steps for inspection readiness, fostering a culture of compliance.
  4. Documentation Management: They ensure that all required documents are up to date, organized, and readily accessible, simplifying document retrieval during inspections.
  5. Continuous Improvement: Regularly updating checklists based on previous inspection experiences and changing regulations promotes a culture of continuous improvement.

What to Include in an Inspection Readiness Checklist

The following areas should be part of checklists that encompass your Inspection Readiness program:

  1. Regulatory Requirements: List and be aware of specific regulations, guidelines, or standards applicable to your industry or organization (ie. FDA, EMA, Health Canada, etc).
  2. Document Review: Verify the accuracy and completeness of essential documents, such as SOPs and regulatory records.
  3. Training and Competency: Document employee training and certifications to ensure competence and qualification.
  4. Facility and Equipment maintenance (if applicable): Regularly inspect and maintain infrastructure and equipment to meet regulatory standards.
  5. Quality Control and Assurance: Evaluate quality control and assurance processes to prevent deviations and non-conformances.
  6. Risk Assessment: Identify potential risks within processes and develop strategies to mitigate them.
  7. Corrective and Preventive Actions (CAPA): Track and address open CAPAs to demonstrate a commitment to improvement.
  8. Internal/Mock Inspections:  This will include internal and mock inspection schedules, simulations and documentation to help identify gaps and improve readiness.
  9. Communication Plan: This helps to outline how your organization will communicate with regulatory agencies and inspectors during the inspection.
  10. Emergency Response Plan: Prepare for unexpected situations with an emergency response plan.

In conclusion, checklists are indispensable. An effective checklist should encompass all relevant aspects of the organization’s operations, from regulatory compliance to documentation management, to guarantee a successful Inspection Readiness program. 

If you are seeking alignment within your team but are struggling with where to start in regard to creating an Inspection Readiness checklist for your company, Contact us! We’d love to hear from you to discuss strategies!

 

6 Steps to Creating SOPs for Quality and Compliance

SOPs are crucial for ensuring compliance and conducting clinical trials. SOPs provide a standardized approach to clinical research processes, which is essential for maintaining consistency and quality across all study sites and participants. The lack of SOPs may result in several issues, such as inconsistent practices that result in disparities in data collection, analysis, and reporting, which may weaken the accuracy and dependability of the study outcomes.

Adhering to ethical and regulatory requirements in a research study can be challenging. Failure to follow standard operating procedures (SOPs) in clinical research can result in reduced efficiency and waste of time and resources in trying to determine the optimal way to perform tasks.

Why SOPs are Important for Clinical Research?

SOPs are important to clinical research as they provide:

  1. Detailed guidelines for the implementation of GCP principles which ensure that clinical trials are conducted in conformity with the ethical considerations and scientific quality standards.
  2. A standardized and streamlined approach to study procedures reducing variability of study tasks while also increasing inspection readiness strategies.
  3. Increased assurance of the safety and well-being of study participants as alignment of procedures and ethical practices and are in place.

Steps to Creating Effective SOPs

Creating effective SOPs can be challenging, but a well-designed and executed SOP can save time and resources, improve the quality of research, and reduce the risk of errors.

1.     Establish the SOP development team

The first step in creating effective SOPs for clinical research is to establish an SOP development team. The team should consist of individuals with relevant expertise and experience, including clinical research professionals, study coordinators, regulatory experts, and other stakeholders. The team should be responsible for overseeing the development and implementation of the SOPs.

2.     Identify the process

The next step is to identify the process for which the SOP is being developed. It is important to clearly define the process and the scope of the SOP. The process should be well understood by the team, and it should be clearly defined in the SOP to avoid any confusion or misinterpretation.

3.     Conduct a process mapping exercise

A process mapping exercise is a useful tool for developing SOPs for clinical research. It involves visually mapping out the process and identifying the key steps, inputs, and outputs. This exercise helps to identify areas where the process can be streamlined or improved, and it ensures that all steps are accounted for in the SOP.

4.     Develop the SOP

The next step is to develop the SOP. The SOP should be written in a clear and concise manner, using simple language. The SOP should include the purpose of the process, the step-by-step instructions for executing the process, the roles and responsibilities of team members, and any relevant references or supporting documents. The SOP should also include a section for deviations and corrective actions.

5.     Review and approve

Once the SOP has been developed, it should be reviewed and approved by the appropriate stakeholders. This includes the SOP development team, the study sponsor, the regulatory authority, and any other relevant parties. Feedback should be incorporated into the SOP, and revisions should be made as necessary.

6.     Train and implement

Training and implementation of the SOP should be conducted by the SOP development team. The team should ensure that all relevant personnel are trained on the SOP, and that the SOP is implemented consistently and effectively. The team should also monitor the implementation of the SOP and make any necessary updates or revisions.

Conclusion

In conclusion, creating effective SOPs for clinical research is critical for ensuring regulatory compliance, data integrity, and risk management. By following these six steps, the development team can create an effective and efficient SOP that will benefit the research team and the quality of the research.

 

Preparing For Pharmacovigilance FDA Inspections

The concept of pharmacovigilance—derived from the Greek and Latin ‘Pharmakon’ (medicinal substance) and Vigilia (to keep watch)—emerged in earnest among physicians and other health experts almost 200 years ago. Initially, the practice amounted primarily to letters and reports written by physicians on the safety and effectiveness of various drugs given to their patients.

Pharmacovigilance inspections (Good Pharmacovigilance Practices, GVP) are designed to assess compliance with the legally prescribed mandatory reporting of adverse drug reactions in clinical trials as well as spontaneous reports. 

The three (3) most common findings noted from FDA’s Post-marketing Adverse Drug Experience (PADE) inspections according to the Bioresearch Monitoring (BIMO) Fiscal Year 2021 Metrics  are:

  • Failure to develop written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing adverse drug experiences
  • Late submission of 15-day Alert reports
  • Late submission of the annual safety report

This article will list ten (10) key areas or documentation to have ready for FDA in an upcoming GVP inspection.

What To Have Ready for an Inspection

  1. Written Procedures
    You must develop, maintain, and follow written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing safety information. This includes procedures for managing safety information with contractors and business partners, as applicable.
  2. Individual Case Safety Reports (ICSRs)
    ICSRs describe one or more adverse experiences related to an individual patient or subject. A valid ICSR contains a suspect drug, an adverse experience, an identifiable patient, and an identifiable reporter.
  3. Scientific Literature Reports
    Regarding scientific literature reports, ensure that there is documented evidence of:
     Scientific literature reviews and the frequency of each review.
     Submission of expedited ICSRs for adverse experiences obtained from the published scientific and medical literature that are both serious and unexpected
    • Foreign Post-marketing Adverse Experience Reporting
      For participating affiliates, subsidiaries, contractors, and business partners outside the United States, ensure the following:
       There are written procedures that address the surveillance, receipt, evaluation, and reporting of adverse experiences.
       There is documented submission of serious and unlabeled (i.e., unexpected) adverse experiences to the FDA within 15 calendar days.
    • Solicited Safety Data
      Solicited safety data arises from organized data collection systems, which may include patient assistance programs, patient support programs, physician engagement programs, or any active solicitation of information from patients or providers, when contact between the sponsor company and the patient or provider is predictable in the context of a specific program.
    • Aggregate Safety Reports
      For each approved application or biologics license, FDA requires the submission of Periodic Reports, which describe safety information obtained during the reporting interval. The reporting interval is quarterly for the first three years following the approval of the application or license, and annually thereafter, unless FDA instructs the sponsor otherwise.
    • Contractor Oversight
      Oversight of outsourced services may include a broad range of activities to ensure that all outsourced services and activities associated with post-marketing safety are performed according to applicable FDA regulations.
    • Electronic Submissions
      Determine if safety report submissions are in an electronic format that FDA can process, review, and archive, as required.
    • Waivers
      Any post-marketing safety waivers from the regulatory requirements must follow applicable procedures and terms of the waiver.
    • Recordkeeping
      For approved drugs or biologics, ensure that all records containing information relating post-marketing safety reports (whether submitted to FDA) have been maintained for a period of 10 years, or for combination products, the longest retention period applicable.

    Conclusion

    Post-marketing safety data collection and adverse event reporting is a critical element of the Food and Drug Administration’s post-marketing safety surveillance program for FDA-regulated drug and therapeutic biologic products.  Incorporating the FDA requirements and guidance into your inspection readiness program contributes to the success of your GVP inspection.

    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].