This is part of our new series of short-form expert discussions spanning regulatory, quality, and clinical domains. Our goal is to quickly deliver actionable insights that industry teams can immediately apply within their organizations. If you have best practices that could benefit fellow life science and medtech professionals, we invite you to share your expertise by filling out this form to become a contributor.
Posts like this will be behind a paywall in the future. If you haven't already, upgrade to a paid subscription and join the hundreds of other professionals there.
Based on his experience in the field, Klaus Goodwin, a former biopharma senior executive and now an independent consultant, shares his insights into the common pitfalls of CQM and offers strategies to overcome them. (See Klaus’s previous insights into writing effective SOPs here.)
Need expert clinical quality management assistance? Whether you need to fill a single role or multiple roles on your clinical team, we connect you to professionals with experience and expertise across all phases, therapeutic areas, and locations. We augment and scale your in-house clinical operations team through contracted staff augmentation or direct-hire arrangements, maximizing cost-effectiveness, flexibility, and scalability. We typically serve as a resourcing partner for companies preparing to enter Phase 2 or 3 trials that need to contract with skilled ClinOps professionals. We help fill select roles as needs fluctuate with new R&D initiatives. Whether you manage clinical operations yourself, contract some functions to a CRO or FSP, or take a combined approach, we have the deep clinical expertise and large talent network to fill select roles whenever and wherever they arise. Learn more about our clinical operations consulting services.
Talk to us when you need to support staffing assignments, lead and manage related activities, bridge staffing gaps, and access long-term or interim leadership.
The following has been edited for brevity.
Reflecting on your career and experience, could you share some common challenges you’ve seen and 'lessons learned' from clinical quality management?
One of the biggest challenges I've seen time and time again is when quality professionals aren't involved enough in clinical programs. A lot of companies seem to think that their clinical operations teams can handle quality management all on their own, but that often leads to gaps in quality oversight. You need quality professionals on hand to provide advice, keep an eye on vendor quality, and manage any quality-related issues that come up. They should be embedded right there within the clinical teams to make sure any quality questions or concerns are dealt with quickly.
Another big issue I often notice is when clinical trial protocols aren't evaluated thoroughly enough for risks. It's absolutely essential to establish quality measures and acceptable levels, especially once you get to Phase 2 and beyond. Quality professionals can really help out the clinical development and operations teams by digging into those protocols, identifying the major risk factors, and coming up with effective metrics for ongoing monitoring during the trial. Without those evaluations, it's a real struggle to keep up with continuous monitoring and proactive risk management throughout the trial.
I've also seen many cases where there just isn't enough resourcing for quality management in general. Some pharma companies tend to underinvest in quality resources, assuming that quality will just take care of itself without dedicated oversight. Making sure quality professionals are involved in developing core plans for clinical trials, like monitoring plans and safety management plans, helps ensure these documents are rock-solid and make sense for the sponsor overseeing the CRO's activities.
Another common problem is when there aren't any quality agreements in place with CROs. While GCP guidelines don't always require them, these agreements add a ton of value by strengthening vendor oversight. They spell out the exact quality metrics that vendors need to report, which boosts compliance and performance. Standard metrics like protocol deviations and deviations to clinical trial endpoints should be monitored frequently to manage risks effectively.
Relying on outdated or insufficiently detailed SOPs can also dampen clinical quality management. SOPs need to be living, breathing documents that are regularly reviewed and updated to reflect current practices, technologies, and regulatory changes. It's crucial to embed a culture that sees SOPs as dynamic rather than static. Regular updates, driven by a structured review process that includes feedback from all stakeholders, help keep the SOPs relevant and practical over time.
In your experience, what are the key metrics or indicators that reliably predict clinical trial quality, and how should organizations prioritize these metrics?
When it comes to key quality metrics in clinical trials, there are a few that I've found to be critical in predicting and ensuring the overall quality and success of the trial. In my experience, protocol deviations, adherence to clinical trial endpoints, and patient compliance — especially with electronic data capture systems like eDiaries — are the ones to watch out for.
Protocol deviations, in particular, can be a major red flag. They can happen for all sorts of reasons, like mistakes in execution, participants not following the rules, or unexpected situations popping up, which certainly happens during a trial. Keeping a close eye on these deviations is crucial because they’re often the first solid indicator you have to know where the trial isn't running according to plan. If you're seeing a lot of deviations or really significant ones, that's a sign that there might be some serious issues with the trial design or how it's being carried out. That's why regularly reviewing these deviations is so important; it lets you spot systemic problems early on and take corrective actions to keep the trial on track.
Adherence to clinical trial endpoints is another big one. Sticking closely to endpoints is obviously essential for the validity and reliability of the trial. So, continuously monitoring and reporting on how well the trial is adhering to these endpoints is key to maintaining the overall quality and reliability of the trial.
When it comes to prioritizing these metrics, it's all about assessing the risk they pose to the trial's success. For example, if an endpoint is heavily dependent on patient-reported outcomes, then compliance with eDiary entries becomes super important. Organizations need to take a hard look at the potential impact of each metric on the trial's outcomes and prioritize monitoring and managing the ones that could cause the most problems.
Establishing a solid reporting mechanism for these metrics is also crucial. You want to make sure they're being reviewed regularly to maintain the integrity and quality of the clinical trials. Having regular, systematic reporting keeps all stakeholders in the loop about the trial's progress and any issues that might be arising. This kind of transparency is key for making timely decisions and taking corrective actions, which reduces the risk of the trial failing because of quality issues that went unnoticed or unmanaged.
In one of the clinical trials I worked on, the primary endpoint was linked to electronic data capture through eDiaries. We spent a lot of time discussing eDiary compliance and set up a daily reporting mechanism to monitor compliance rates. This allowed us to identify and address compliance issues early on, ensuring that the data we collected was accurate and complete.
Do you have any advice for industry teams on how to better engage various stakeholders (e.g., sponsors, CROs, participants) in the quality management process, and what strategies motivate their active participation and cooperation?
First off, establishing clear quality agreements with CROs is an absolute must. These agreements need to spell out the exact metrics, reporting requirements, and responsibilities of everyone involved. It's essentially the game plan that keeps everyone on the same page.
Another strategy is involving stakeholders in developing SOPs and assessing protocols. When they're part of the process, they're simply more likely to understand and follow those procedures. Plus, it ensures that the SOPs and protocols are practical and cover all the bases.
Regular meetings and transparent reporting are also key to keeping stakeholders engaged throughout the trial. These meetings give us a chance to step back, look at the progress, discuss any challenges, and make adjustments if needed. Collaborative review processes, where stakeholders review and update SOPs and protocols, are also super effective for ensuring that we're always improving and adhering to quality standards.
When engaging sponsors and participants, you need to tailor your approach. For sponsors, regular updates and clear communication are critical, and involving them in decision-making processes helps build that trust. For participants, it's all about clearly communicating the trial's purpose, procedures, and their role in maintaining quality.
Motivating active participation is all about recognizing and addressing the needs and concerns of each stakeholder group. For CROs and clinical staff, providing training, resources, and recognition can really boost their engagement. And for participants, making sure they're comfortable and acknowledging their contributions to the trial's success can go a long way in motivating them to actively participate.
In one trial I worked on, we set up a quality council that had representatives from all the stakeholders. This council met regularly to collaboratively review metrics, discuss challenges, and come up with solutions. And let me tell you, it made a huge difference in the trial outcomes.
So, to sum up, clear agreements, involving stakeholders, regular communication, collaborative reviews, a quality-driven culture, tailored engagement strategies, and recognizing and addressing needs are the secret sauce for getting stakeholders on board with the quality management process.
What are some ways organizations can proactively identify and manage risks in clinical trial quality management, and could you provide an example of an effective risk management strategy?
First and foremost, proactive risk management starts with thorough risk assessments during the protocol development stage. When developing the protocol, you need to systematically identify all the potential risks that could impact the trial. This includes patient safety, data integrity, regulatory compliance, operational efficiency —everything.
Identifying potential risks means looking at every aspect of the trial: the design, participant selection criteria, data collection methods, regulatory requirements, and more. You need this assessment to pinpoint areas that could pose significant risks, like complex inclusion/exclusion criteria, relying heavily on patient-reported outcomes, or navigating stringent regulatory requirements.
Once you understand the potential risks, the next step is to establish key quality indicators (KQIs) and determine the acceptable levels for these indicators. KQIs are like the vital signs for the trial — specific metrics that provide insight into the quality and performance. These could include things like the rate of protocol deviations, patient adherence to treatment regimens, or the speed of data entry. Tolerance levels are like the acceptable range for these indicators; they establish the benchmarks for what's considered acceptable. If any of these indicators exceed the tolerance levels, it's a warning sign that potential risks need attention.
I tend to suggest using planned process deviations for minor changes. This method allows for quick adaptation to minor changes without having to start from scratch with SOPs. Essentially, you pre-approve minor deviations from standard procedures under specific conditions, ensuring these changes are documented and controlled. This flexibility helps maintain operational efficiency while effectively managing risks.
Another important aspect of risk management is the establishment of a strong reporting mechanism. This involves creating systems to continuously monitor key quality indicators and promptly report any deviations or issues. Regular reporting acts as an early warning system, allowing you to quickly identify emerging risks and take corrective actions. For instance, generating daily or weekly reports on patient compliance, protocol deviations, and data integrity can help you keep a close watch on the progress of the trial and pinpoint areas that require attention.
Developing and implementing comprehensive risk mitigation plans based on the risk assessments and identified KQIs is crucial. These plans should spell out specific actions to be taken when risks are identified, including who's responsible for what, setting timelines, and establishing follow-up procedures. Regular training and simulations can help ensure that everyone on the team is ready to execute these plans effectively.
Engaging all stakeholders in the risk management process is also key. This means looping in sponsors, CROs, investigators, and regulatory authorities. Regular meetings and transparent communication about identified risks and mitigation strategies foster a collaborative approach to risk management. When everyone's aware of potential risks and their roles in managing them, it's a recipe for success.
Lastly, implementing feedback loops and promoting a culture of continuous improvement is vital for effective risk management. Regularly reviewing risk management outcomes and soliciting feedback from all stakeholders helps identify areas for improvement. Adjusting risk management strategies based on lessons learned and emerging best practices ensures that the approach remains effective and relevant.
What role does technology play in enhancing clinical quality management, and can you recommend any specific tools or platforms that have been particularly effective that might be overlooked?
Technology plays a huge role in supporting QMSs by automating a lot of the manual processes involved in clinical trial management — everything from SOP management and deviation tracking to document control and inspection readiness. Organizations that master their tech reduce human errors, ensure timely updates and reviews, and maintain a robust and compliant QMS.
One tool that I think is essential for managing trial documentation is an Electronic Trial Master File (eTMF) system. These systems are like a central hub for all trial-related documents, making them easily accessible and ensuring they're always up-to-date. They’re also a game-changer when it comes to inspection readiness. They provide a comprehensive and organized repository of all necessary documents, which can be quickly accessed during an audit or inspection. Not only does this save a ton of time, but it also ensures that the trial is complying with all the regulatory requirements.
Another set of tools that I highly recommend are QMS platforms like Veeva Systems. These platforms offer robust solutions for managing various aspects of clinical trials, including SOP management and deviation tracking. What's great about these platforms is that they automate reminders and updates, ensuring that SOPs are regularly reviewed and updated to reflect current practices and regulatory changes. Take Veeva's QMS, for example. It supports SOP management by providing tools for document creation, approval workflows, and training management. This reduces reliance on manual processes and ensures that everyone on the team is aware of the latest procedures and regulations.
Deviation tracking tools within QMS platforms are also crucial for identifying and managing deviations from SOPs and protocols. These tools provide a systematic approach to logging, investigating, and resolving deviations, helping to maintain trial integrity. Automated deviation tracking ensures that all deviations are documented and addressed promptly, reducing the risk of non-compliance and improving overall trial quality.
One aspect of QMS platforms that I think is sometimes overlooked is the power of automating reminders and updates. This feature helps maintain compliance by ensuring that all required actions are completed on time, including SOP reviews, training updates, and corrective actions. Automated systems send reminders to relevant team members, making sure that nothing falls through the cracks and that all tasks are completed in a timely manner.
Klaus’s CQM action items at a glance
Embed quality professionals in clinical teams: They provide critical oversight and risk management.
Regularly assess and update protocols: Ensure that quality indicators and tolerance levels are defined and monitored.
Develop and enforce quality agreements with CROs: Clearly outline quality metrics and reporting requirements.
Foster a strong quality culture: Leadership must drive quality initiatives and support a proactive approach to quality management.
Utilize technology for QMS: Leverage digital tools to enhance compliance and streamline quality processes.
A few questions for self-assessment
Do you have quality professionals integrated into your clinical teams?
Are your clinical trial protocols regularly assessed for risk?
Have you established clear quality agreements with your CROs?
Is there a strong quality culture driven by leadership within your organization?
Are you leveraging technology to support your QMS?
Need expert clinical support? Talk to us.
About Klaus Goodwin
Klaus is a distinguished biopharma senior executive with over 25 years of experience, now serving as an independent consultant. His career is marked by success in providing quality oversight and direction, utilizing a risk-based and stakeholder-driven approach to enhance operational efficiencies and ensure compliance across all phases of clinical development. Klaus's expertise spans Clinical Compliance, Auditing (Phase I – IV), Vendor Quality Governance (GMP/GLP/GCP/GVP), Clinical Quality Management System Design, M&A Due Diligence, and QMS Integration.
His approach combines empowering leadership with strategic execution, emphasizing education and supportive frameworks to achieve high-quality outcomes. He is also a Lean Six Sigma Black Belt, skilled in GCP Process Development and Design, Quality Risk Management, and CAPA program design and execution. Based in Dubois, Wyoming, Klaus continues to influence quality assurance and auditing practices globally, ensuring his strategies align with current industry standards and regulatory expectations.
Contact us to put these practices and principles to work for your organization.
The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates.
Need expert help planning and executing compliance projects or connecting with a quality and compliance professional? Get in touch with us. If we haven’t worked together yet, watch our explainer video below or head to our company introduction page to see if we could help you execute your projects now or in the future.
Our service areas:
Quality Assurance | Regulatory Affairs | Clinical Operations | Commissioning, Qualification, and Validation | Chemistry, Manufacturing, and Controls (CMC) | Expert Witness
Our engagement models:
Consulting Projects | Staff Augmentation | FTE Recruitment | Functional Service Program
Our podcast:
Apple | Spotify | YouTube | Web + Others
Modernizing Clinical Quality Management: A Q&A with Klaus Goodwin, EQSM, LSS BB