4 Imperatives For Updating Our Clinical Quality Systems Approach For 2022 Pharma

Industry standard practices and business models of the 1980s and ‘90s informed the development and establishment of clinical quality systems, bringing new efficiencies to our industry that aligned with applicable regulations. As skyrocketing technological advances began to rain down upon us, we were determined to maintain industry standard quality assurance and compliance approaches. It seemed to work well for a while. Yet, over time, the industry standards began to make less and less sense, even as the regulations held steady.

A gap has been widening over the past 10 to 15 years. In 2020, the COVID-19 pandemic drove us toward a new level of digitalization at an unexpected speed. Social distancing requirements accelerated the already occurring movement toward decentralized clinical trials (DCTs). Now, restrictions are lifting; life – and the pharma industry – have fundamentally changed. However, excitement is in the air! There is a tremendous amount of discussion and movement to explore how our industry can develop new and innovative approaches for collecting and managing data, monitoring investigator sites, and adapting traditional site activities. Clinical timelines have grown shorter and shorter. Operational deliverables are being met at faster and faster rates. Yet when it comes to innovation and change in the clinical quality systems, quality assurance, and compliance arena, crickets are chirping. Sure, electronic systems are popping up everywhere but, in case you’re unaware, assurance and oversight of quality and regulatory compliance is about much more than an electronic system.

Since 1991, we’ve seen dramatic industry changes in the following aspects: outsourcing, remote monitoring, career development for pharma professionals, general technology, and the use of electronic systems in clinical research, sponsor oversight, pharma company ownership/leadership, and global logistics. The clinical quality management systems approach developed 20 years ago is not sustainable in the today’s industry.

Quality assurance and compliance professionals and functions − the discipline − were beginning to make an impact when, somewhere around the late 1990s, technology knocked on the door, and then seemed to bust it down. We were learning about Six Sigma, Lean, and Malcolm Baldridge – and the C-suite was intrigued. We did our best as the industry began to morph until we, too, were outsourced. This was great for those of us who have considerable experience in the industry; however, the career development pathways for those following us were weakened. This has become the case for many industry functions, pushing up the complexity level when the question is: What do we do now?

If establishing a foundation through traditional means is no longer feasible, a builder doesn’t simply shrug it off and start laying wire. Instead, they put on their thinking cap, develop a novel approach, and get it done. This is the hallmark of human ingenuity, and it’s exactly what our industry needs. We must begin asking questions and questioning why we do what we do.

I propose that the most important question for our 2022 industry is: What does a quality system capable of ensuring data integrity and patient safety in a highly decentralized, technology driven drug development process look like?

Following are recommendations for how clinical research and development operational and quality assurance professionals can begin to tackle this exciting challenge.

1. Form new avenues of communication and collaboration.

To remodel the outdated clinical quality management systems approach, pharma and regulators must form new avenues of communication and collaboration. Such a remodel is not solely within our scope of influence as clinical pharma professionals; however, we can begin to take stronger actions to influence our regulatory counterparts in this area. This is the trickiest challenge; it’s not easy for individuals and companies to feel comfortable approaching regulators about industry quality and compliance gaps due to our long-established mindset of “only answer the questions asked – never proactively offer information that wasn’t requested.” There is a logical rationale for that mindset, and it remains in place; however, as an industry, nothing is going to change if nothing changes and if no one speaks up. The big industry picture is the best place to start.

Actions to consider and further develop include:

• Commit to taking advantage of the existing opportunities we do have to interact directly with regulators. Spend time on regulatory websites to explore these options, reach out, and encourage others to do so.
• Use available resources to proactively appeal to the FDA to develop and offer more opportunities for personal interaction. We need to move beyond waiting for an annual conference to ask regulators questions. Pick up the phone, email, create and send petitions, etc. to bring quality management systems-related industry gaps to the table for discussion.
• Use available resources to suggest roundtables that include key participants, based on their expertise, to discuss both big picture and specific quality systems topics.
• Explore avenues to establish a more formal joint industry/FDA commission to explore clinical (and GxP-wide) quality management system gaps forming due to industry changes.
• Provide mentoring to staff on how to reach out to regulators on behalf of themselves as experienced, qualified pharma industry professionals rather than as a representative of the company. This is tricky, but pharma professionals need to be comfortable to discuss big picture industry gaps and collaborate with regulators as independent professionals.

2. Invest in a solid clinical compliance strategy from Day 1.

As early as possible in corporate formation and development, senior leaders must commit to investing the time and funds required to establish and execute a solid clinical compliance strategy.

Actions to consider and further develop include: 

• When building your C-suite, give a chair to a chief compliance officer with knowledge of both corporate and GxP compliance.
• Include appropriate budgeting for quality and compliance activities from Day 1.
• Invest your own time in researching and gaining insight and information about the science of quality management and the regulatory requirements in which you intend to operate. This enables you to make more informed decisions regarding risk-based compliance strategy.
• Engage highly qualified quality and compliance consultants to assist in screening and interviewing staff for key positions. Who better to assess whether a candidate is qualified for clinical (and other GxP) roles and responsibilities than those who have spent their careers conducting regulatory audits and assessments?
• Engage and trust experienced quality and compliance professionals to adapt existing or develop foundational, compliant quality management systems that support decentralized clinical development.
• Create and communicate a quality policy and stand behind it from Day 1.
• If Day 1 is behind you, start now. Assess your state of compliance. Create storyboards to document and prepare to discuss the past. Move purposely forward today.

3. Prioritize regulatory education for all employees and foster interest in strengthening pharma industry knowledge.

In this expanding decentralized environment, management must ensure that employees have the time and resources to build their knowledge of the regulatory requirements that apply to their areas of operational expertise and the overall drug development process. Training on standard operating procedures is not enough to support progression to positions with greater responsibility and ensure functions are compliant and processes are designed to support compliance. We are developing too many managers and leaders who do not fully understand the big picture or the regulatory requirements and their critical importance in the future of our industry.

Actions to consider and further develop include: 

• Seek to create a culture where employees understand that a key developmental goal is to become experts on the regulations that apply to their areas of operational expertise.
• Tie the regulatory expertise expectation to employee annual goals; ensure that annual goals are established from Day 1 in your corporate history.
• Take specific actions to ensure that job candidates have excellent written and verbal communications skills and expert knowledge of regulatory requirements. These common points on job descriptions are in jeopardy of becoming only words on the page. They are truly critical to success on multiple levels.
• Budget for regulatory training activities and opportunities.
• Encourage or require staff to spend one hour a week reading information on one or more regulatory websites.

4. Hold employees accountable for quality & compliance requirements and goals from Day 1.

Documenting and communicating quality and compliance expectations comes first. Senior leaders must proactively build and foster a quality culture in which employees understand and believe that the documentation goes far beyond words on paper. There are powerful, proven methods for building such a culture, most of which include accountability. A key concept in the proven science of quality management is root cause analysis. Although we accept that human error exists, quality management teaches us to have a systems and process perspective. However, it’s critical to have a top-down leadership mindset and message that the processes and standards that our industry, regulators, and companies require are important. Independently, each item and action may not seem to make a significant difference, yet it is the culmination of each action, decision, etc. taken by each person who touches a regulated process that ultimately builds or inhibits data integrity and patient safety. If Day 1 is behind you, start today.

Actions to consider and further develop include: 

• Actively communicate the importance of adhering to quality and compliance requirements.
• Tie compliance requirements for individuals to annual goals. Examples are on-time completion of assigned training or demonstrating respect for compliance by completing required forms. There are ways to hold individuals accountable without blame or having unrealistic expectations related to human error.
• Challenge company requirements. If it’s truly not important or is inefficient, why is it required? Implement the mindset and suggested actions above to actively seek to understand what is required by regulators due to the impact on data integrity and patient safety -- and do it. Throw the rest of it out the door; it may be busy work. If you’re unsure, refer to item 1: Pick up the phone and ask a regulator.

My next article will take a deeper dive into the specific types of clinical quality management system changes that are well suited for a more decentralized model of drug development and commercialization. I’ll provide more specific ideas on how to address the complex gap that’s forming right under our noses as we thrill to vendor fever and celebrate electronic everything.

About The Author:

Penelope Przekop is a corporate quality management expert. Throughout her 30+ year career, she has worked with numerous Fortune 100 pharma companies, including Pfizer, Merck, Lilly, and Glaxo Smith Kline, and held leadership positions at Novartis, Covance, Wyeth, and Johnson & Johnson. She is the founder and CEO of PDC Pharma Strategy and serves as the Chief Compliance Officer for Engrail Therapeutics. She is the author of Six Sigma for Business Excellence (McGraw-Hill). Przekop earned a BS in biology from Louisiana State University and an MS in quality systems engineering from Kennesaw State University. She is a graduate of the Smith College Program for Women’s Leadership and the Rutgers University Senior Leadership Program for Professional Women. Her new book, 5-Star Career: Define and Build Yours Using the Science of Quality Management launches in November 2021 from Productivity Press.