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Enhancing Clinical Trial Outcomes Through Quality Improvement

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Continuous Quality Improvement (CQI) is essential in clinical research, impacting both data integrity and participant safety. By incorporating CQI throughout the clinical trial process, research teams can consistently meet and even exceed regulatory standards. This approach leads to more efficient, reliable, and impactful trials. Here’s how CQI can transform clinical research and why understanding its principles is valuable for professionals looking to elevate their expertise.

Optimizing Clinical Research Processes

First and foremost, CQI is about continuously refining processes at each stage of the clinical trial lifecycle. By analyzing protocols and outcomes consistently, research teams can quickly identify inefficiencies and correct errors that could otherwise compromise trial results. For example, CQI enables real-time adjustments, which boost data accuracy and reliability, ultimately making trials faster, safer, and more cost-effective. With a focus on process optimization, clinical sites can position themselves as leaders in both quality and compliance.

Putting Participant Safety First

Additionally, participant safety remains the top priority in any clinical trial. CQI emphasizes proactive monitoring and improvement of safety protocols, ensuring that risks are managed swiftly and effectively. By integrating CQI into safety practices, sites can enhance their response to adverse events, protecting participants while meeting essential ethical and regulatory standards. This commitment to safety not only builds trust but also strengthens the trial’s credibility and reliability.

Ensuring Data Integrity and Regulatory Compliance

Data quality is also critical for regulatory acceptance and the overall success of clinical trials. CQI strengthens data integrity through rigorous checks and balances, ensuring that collected data is accurate, verifiable, and compliant with FDA and EMA standards. With a robust CQI framework, regulatory compliance becomes an integral part of the trial process. High data integrity and strong compliance lead to more reliable outcomes, advancing the trial’s impact.

Building a Culture of Continuous Improvement

Beyond process and data improvements, CQI fosters a culture of continuous learning within research teams. Engaging staff in quality-focused practices encourages a proactive and motivated work environment, enhancing team performance and job satisfaction. Furthermore, a workplace culture grounded in CQI inspires staff to seek out new ways to implement continuous improvements, promoting innovation and operational excellence across the trial lifecycle.

How to Implement Effective CQI Practices in Clinical Trials

For clinical sites looking to adopt CQI successfully, several strategies can help:

  1. Provide Regular Training: Equip team members with up-to-date CQI techniques, ensuring that everyone understands their role in maintaining quality.
  2. Leverage Technology: Use technology to monitor performance metrics and quickly identify areas for improvement.
  3. Engage Stakeholders: Actively involve stakeholders, including patients, in quality initiatives to gain diverse insights for meaningful improvements.

Enhance Your CQI Knowledge with Targeted Training

For professionals interested in deepening their expertise in quality improvement, our course, Preparing for FDA GCP Inspections – Best Practices for Clinical Sites, offers invaluable insights. This program covers key areas like inspection readiness and CQI principles, providing practical tools to help you elevate clinical research quality. By mastering these practices, you can make a significant impact on trial outcomes and compliance standards.

Strengthening your understanding of CQI will empower you to contribute to higher standards in clinical research, ensuring both participant safety and trial success.

Navigating the Documentation Requirements for FDA GCP Inspections

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Proper documentation is critical for passing FDA GCP inspections. It demonstrates compliance with regulatory requirements while ensuring clinical trials are conducted with the highest level of accuracy, integrity, and transparency. For any clinical research site, maintaining thorough, organized, and accessible documentation is key to staying FDA inspection-ready. This article provides practical insights on what documents to maintain, best practices for record-keeping, and the benefits of utilizing technology to enhance your compliance strategy.

Understanding What to Document in Clinical Trials

To comply with FDA GCP guidelines, clinical trial sites must document every aspect of the trial to ensure there is a clear and complete audit trail. Essential documents include:

  • Patient consent forms
  • Trial protocols and amendments
  • Staff training records
  • Adverse event reports
  • Drug accountability logs
  • Monitoring visit reports
  • Correspondence with regulatory bodies

These records must be meticulously maintained to reflect all actions and decisions made during the trial. Complete and accurate documentation is vital for ensuring the trial’s integrity and protecting the safety of trial participants.

Best Practices for Maintaining Clinical Trial Documentation

Proper documentation management involves more than just storing files. By implementing these best practices, clinical sites can ensure their documentation is always prepared for FDA GCP inspections:

1. Implement a Robust Document Management System (DMS):
A well-organized DMS is essential for storing, organizing, and tracking documents. This system helps maintain version control, ensures document security, and makes retrieval easy during inspections.

2. Conduct Regular Audits and Reviews:
Internal audits are crucial for verifying the accuracy and completeness of documentation. Regular reviews allow you to spot inconsistencies or gaps in records, giving you the opportunity to resolve issues before an official FDA inspection.

3. Train Staff on Documentation Requirements:
Staff training is key to maintaining proper documentation. Make sure all staff members involved in the trial understand FDA GCP documentation requirements, version control, and the importance of accuracy. Properly trained staff ensure that documentation remains thorough and compliant with regulatory guidelines.

The Role of Technology in Managing Clinical Trial Documentation

Leveraging technology can significantly improve the management of clinical trial documentation. Utilizing electronic systems like eTMF (electronic Trial Master File) streamlines document storage and retrieval, enhances security, and ensures compliance. Key advantages of electronic systems include:

  • Centralized storage for easy access to all necessary documents during inspections.
  • Version control and audit trails to track changes and maintain compliance with regulatory standards.
  • Improved data integrity, minimizing errors commonly associated with manual documentation.

By incorporating electronic tools, clinical research sites can ensure that they stay on top of their documentation requirements and streamline the process of keeping records inspection-ready.

Conclusion: Ensuring Your Clinical Site is Ready for FDA GCP Inspections

Proper documentation practices are the cornerstone of successful FDA GCP inspections. By implementing a strong document management system, conducting regular audits, and leveraging technology, clinical research sites can stay compliant with FDA guidelines and protect the integrity of their trials.

Documentation is not just about compliance—it’s about upholding the ethical standards of clinical research and ensuring the safety and well-being of trial participants.

Is your clinical trial site prepared for an FDA inspection? To ensure your documentation is up to par, consider enrolling in our “. This course focuses on setting up and organizing a TMF, understanding applicable regulations and TMF findings, and mastering Quality Control (QC) strategies for audit-readiness.

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

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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!

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.

Tips on Establishing an Inspection Readiness Training Program

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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!

5Cs to Inspection Readiness Success (for Clinical Sites)

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By the 2K Blog /team

Q: When is the best time to start preparing for an inspection?   

    1. After database lock 
    2. After the inspection announcement 
    3. After IND/IDE Submission 

‎A: If you answered C, you are correct. ‎‎ ‎‎ ‎‎Inspection Readiness is an ongoing process that starts at the beginning of the trial. ‎

We all know that inspections can be quite stressful; however, a stressful environment can be minimized with proper preparation and inspection readiness techniques.  This article will discuss the 5C IRS (Inspection Readiness Success) Model as one of the strategies that can be utilized as an inspection readiness technique for clinical research sites.

The 5Cs are: 

  1. Collect Information – In collecting information, it’s important to consider researching from both internal sources (e.g., prior audits, inspections and monitor visit reports) to determine existing gaps in your processes in addition to external sources (e.g., websites of regulatory authorities such as USFDA, EMA, Health Canada, etc.) to review guidance materials, requirements and expectations.

  2. Collaborate with the sponsor – Be proactive in utilizing inspection readiness tools and collaborating with the monitor & sponsor’s inspection team for additional support in preparing for inspections and implementing effective inspection readiness strategies.

  3. ‎Communicate with stakeholders‎‎ – ‎‎Communicate with internal stakeholders (colleagues, PI, monitor) to address gaps in study-related documentation to ensure that they‎‎ ‎‎are present, ‎‎complete‎‎ and accurate.‎‎ ‎‎ ‎‎ I‎‎t’s equally important to ensure that staff are properly prepared to communicate with external stakeholders (e.g., regulatory authorities) and able to interact ‎‎effectively ‎‎with the Inspector/FDA Investigator prior to, during and after the inspection.‎‎ ‎‎ ‎‎ ‎

  4. Correct via CAPA (Corrective and Preventive Action) Plans – Part of having an effective Corrective and Preventive Action plan for each finding is to include all of the elements such as:

    • Root Cause – Why did this happen? Was it a systemic or isolated event? 
    • Correction – What correction was done to immediately resolve this finding?
    • Corrective Action – What will be your corrective action and how will you implement to ensure this finding does not recur?  For example, you may need to create, improve, revise SOPs and checklists/templates and retrain staff on the revised processes.
    • Preventive Action – What are you checks and balances?  Incorporate preventive measures within a timeframe (e.g., 3- 6 months) to ensure similar finding(s) never happens again.

       

  5. Conduct Compliance Checks – Compliance checks involve the evaluation of the implemented processes from your CAPA.   Utilize checklists at frequent intervals to reveal gaps and determine what’s working vs. what’s not.  In addition, review findings from monitoring visits as gauge for compliance checks especially if time and resources are limited at your clinical research site.

Remember, inspection readiness is an ongoing process.  Incorporating an Inspection Readiness strategy, such as the 5C IRS (Inspection Readiness Success) Model, in your daily operations not only creates a culture of compliance, but also allows your site to proactively prepares for and contributes to the success of future inspections.  

Need a checklist for your site? Become a subscriber to download our free Inspection Readiness Checklist!

 

 

Inspection vs Audit:  What’s the difference?

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Audit and inspections are critical methods in achieving compliance.  Both are systematic,  and documented processes conducted to verify that a certain set of standards, guidelines and procedures are being met; however, they are used interchangeably according to their processes.

As an FDA Investigator, the term “inspection” was used most often; however, as I ventured out into the industry to work for sponsor companies and CROs, I heard both terms “audit” and “inspection” used interchangeably depending on who was conducting them.   At the same time, professional organizations like ASQ (American Society for Quality) primarily used the term “audit”.   

According to the sponsor companies I have worked for in the industry, the term “audit” is used when it is conducted either internally within the organization or externally with a supplier.   The term “inspection” is used when conducted by a regulatory authority such as FDA, EMA, ISO, etc.

So, what’s the difference? 

Inspection vs Audit

Regulatory Authorities such as the USFDA(United States Food & Drug Administration), EMA (European Medicines Agency), etc.  use the term “inspection” which is routinely done to:

  • Determine the safety and protection of subjects
  • Ensure adherence to federal regulations
  • Determine the validity of clinicals trials supporting approval applications

According to professional organizations like ASQ (American Society for Quality), everything is considered an audit broken down into different types (e.g., process, product, system, etc.) and parties such as:

  • First-party audit
  • Second-party audit or
  • Third party audit

First party audits, or internal audits, are conducted within an organization to measure its strengths and weaknesses against its own procedures and processes against external standards. 

Second party audits, or supplier audits, are conducted externally on a supplier by a customer to determine that products are being handled properly according to the customers’ procedures / industry stands and services are done according to the requirements of contractual agreement.

Third party audits are conducted independently from outside organizations or regulatory authorities and can result in certification, registration, recognition, approval, etc.

According to the sponsor companies I have worked for in the industry, the term “audit” is used when it is conducted either internally within the organization or externally with a supplier.   The term “inspection” is used when conducted by a regulatory authority such as FDA, EMA, ISO, etc.

Key Takeaway

The best way to minimize confusion is to consider First and Second party audits conducted internally or externally by clients or consultant companies as AUDITS and Third-party conducted by regulatory authorities as INSPECTIONS both with the ultimate goal to achieve compliance and adherence to set standards, guidelines and procedures.

How are audits and inspections differentiated in your company or department?  Feel free to contact us with your comments, questions or feedback.  Looking forward to hearing your thoughts on this topic!

 

 

Inspection Readiness Checklists: 

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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!

 

Pharmacovigilance and Drug Safety

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Recently approved medications and those already on the market can benefit from pharmacovigilance to help ensure patient safety. While pharmacovigilance practices are highly regulated in the context of clinical trials, post-marketing incidence reporting is not properly adopted or enforced. As a result, it is anticipated that adverse events related to medications that are already in the market are underreported by about 90%. Therefore, it can be difficult to identify drug safety problems in individuals who have numerous comorbid conditions and complex disorders.

What is Pharmacovigilance?

The research and practices involved in the identification, evaluation, comprehension, and avoidance of side effects or any other issue involving medications is known as pharmacovigilance.

Before a treatment is approved for use, the only available proof of its efficacy and safety comes from clinical trials, in which patients are carefully chosen and monitored under carefully controlled settings. This indicates that a treatment has only undergone brief testing in a very small number of carefully chosen patients at the time of its authorization.

Following approval, the medication may be administered to a large number of patients, continuously, and in conjunction with other medications. In such cases, some adverse effects could manifest. Therefore, it is crucial to continuously assess the safety of all medications used in medical procedures.

How is Drug Safety Ensured?

For the evaluation of prescription medications, there are regulatory frameworks. First, the FDA examines the efficacy and safety of new pharmaceuticals that manufacturers want to market in the United States during the premarket approval process. The FDA’s examination of the studies in which people use the investigational new medicine in meticulously controlled, typically randomized trials such as Phase 1, 2 and 3 trials.

Second, the FDA takes action through its post market regulatory processes once a maker has sufficiently shown a drug or device safety and effectiveness for a specific population and set of conditions. Clinicians and patients may also report any significant or unusual adverse effects to the FDA.

According to the law, the FDA is authorized to take only limited action if it determines that a product’s post-approval use entails a higher risk of a negative outcome. However, many argue that in addition to needing a wider variety of enforcement measures, FDA also has to make better use of the authority it already possesses.

Six areas are discussed, including the FDA budget, the industry’s role, the opportunity to leverage the drug approval process to improve post market operations, the paucity of post-market data, and the limited public access to data obtained. The FDA is able to execute some of the recommended adjustments. Others would necessitate legislative action.

Conclusion

It is important to understand that no medication is 100% risk-free. A prescription drug is actually one that has “toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug,” according to the Federal Food, Drug, and Cosmetic Act.

Therefore, it is important to ensure that the drug safety plan is working in all areas of the healthcare sector to ensure utmost safety. Regulatory authorities and pharmaceutical medicine pupils must adhere to the fundamental principle and primary objective of pharmacovigilance.


References

Jones, R. (2022, April 16). Pharmacovigilance – a complete guide to Pharmacovigilance and Drug Safety – Clinical Research Certification. CCRPS Clinical Research Taininrg. Retrieved September 24, 2022, from https://ccrps.org/clinical-research-blog/pharmacovigilance-training

The theory and definitions of drug safety — pharmacovigilance. (2019). Cobert’s Manual of Drug Safety and Pharmacovigilance, 1–7. https://doi.org/10.1142/9789813278851_0001

Yehia, D. H. (2022, June 24). Introduction to pharmacovigilance: How drug safety is enforced by pharmacovigilance – pharmacovigilance foundations. Pharmacovigilance Foundations – Simplifying Healthcare Professionals Workspace. Retrieved September 24, 2022, from https://www.pharmacovigilancefoundations.com/pharmacovigilance-introduction/

The Benefits of Storyboarding in Clinical Research Trials

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As part of a sponsor’s inspection readiness activities, storyboarding is a crucial step that provides a solid framework for addressing challenging or important areas of noncompliance via corrective and preventive actions. With the aid of organizational and risk assessments, sponsor companies should be able to pinpoint issues and utilize storyboards to systematically discuss the implementation of action plans with inspectors as requested during an inspection.

Storyboard Benefits

Utilizing storyboards has various benefits.  The top five benefits include the following:

  1. They offer a structure for formulating concise content that the inspection team can convey reliably.
  2. They are particularly beneficial in circumstances where an organization has gone through a transition or considerable change, for closing gaps that have already existed, and in other exceptional cases of self-identified compliance.
  3. They point out the corrective measures taken to guarantee patient safety and maintain data integrity.
  4. They assist in removing ambiguity, potential disagreement, and pressured decision-making while responding to inspection questions about challenging and perplexing clinical trial components.
  5. They lessen the possibility of issues occurring during an inspection as a result of several facilitators or SMEs accidentally giving conflicting accounts of what happened, and the steps taken to address associated problems or gaps.

Storyboard Tips

Being proactive and starting development when a problem or situation emerges can save a ton of time and work later on when attempting to put together a summary later. Therefore, it is a recommended practice to generate storyboards as early as possible.

The following are useful tips regarding a storyboard:

  • A storyboard should be utilized as a tool to assist the facilitators in making sure that important information is accurately and succinctly communicated, and that those informing inspectors are on the same page.
  • The location of pertinent supporting paperwork should be listed on a storyboard so that facilitators can respond to inspection demand swiftly.
  • Storyboards should not be lengthy things of the past with background or unnecessary material, but rather brief and to the point. They are designed to contain minimum amount of information necessary to properly respond to an inspection request.
  • A storyboard’s content can be discussed verbally with an inspector but storyboards themselves should not be shared or mentioned because they are not meant to be discussed in full during an inspection.
  • Storyboards shouldn’t include statements that unintentionally encourage facilitators to disclose information that an inspector might not have otherwise asked, as this could raise further questions and create confusion or ambiguity.

Conclusion

In conclusion, storyboards can offer the foundation required to communicate important information in a clear and simple manner with assurance and in synchronization across all departments of the organization, making the inspection readiness process considerably simpler for all parties involved.

References

Gwizdak , S., & Marshall, M. (2020, December 10). 4 ways to Adapt Your Inspection Readiness Framework in a post Covid-19 World. Halloran Consulting Group. Retrieved August 1, 2022, from https://www.hallorancg.com/2020/06/19/4-ways-to-adapt-your-inspection-readiness-framework-in-a-post-covid-19-world/#:~:text=Storyboarding%20is%20an%20important%20activity,critical%20aspects%20of%20a%20study.

HealthResearchBC. (2020, October 27). Regulatory update: Clinical trial storyboards. Clinical Trials BC. Retrieved August 1, 2022, from https://www.clinicaltrialsbc.ca/regulatory-update-clinical-trial-storyboards/

LifeScienceLeader. (2020). 09.28.20 — bringing clarity to Regulatory Inspection Readiness & Facilitation. 09.28.20 — Bringing Clarity To Regulatory Inspection Readiness & Facilitation. Retrieved August 1, 2022, from https://www.lifescienceleader.com/doc/bringing-clarity-to-regulatory-inspection-readiness-facilitation-0001

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.