Why Quality by Design Is Still Underused in Emerging Biotech, and What Can Be Done About It

Quality by Design (QbD) is widely recognized as a best practice for improving clinical trial quality, ensuring regulatory readiness, and avoiding costly delays So why do so many early-stage biopharma and biotech companies still treat it as optional? 

The answer lies within a mix of misconceptions, resource constraints, and unfamiliarity. And that’s a missed opportunity because, when applied early, QbD can be both scalable and cost-effective. Especially for companies aiming to avoid risk and accelerate development timelines. 

What is QbD, Really? 

At its core, QbD is about building quality into the clinical trial process from the start, rather than inspecting for it later. It is rooted in the principles outlined by the International Council for Harmonisation (ICH), particularly reflected in ICH E6(R2) and E8(R1), and involves identifying critical quality factors early, like essential data elements, high-risk operational activities, and protocol dependencies, and designing trials to minimize risk and ensure alignment across functions. 

When used correctly, it’s a framework that supports better decision-making, clearer communication, and more robust outcomes. But too often, small and mid-size biotechs underestimate its impact and, often, their ability to implement QbD effectively. 

Common Misconceptions in Emerging Biotech 

Among emerging biotech companies, the most common reasons for skipping QbD are more about misconceptions than any disagreement with the principles: 

• “QbD is just for big pharma.” There’s a persistent myth that QbD requires massive infrastructure or large quality management teams. In reality, QbD can be tailored to fit any company size. The earlier it’s adopted, the easier it is to scale as a company grows. 
• “We’ll worry about that later.” Many small sponsors think they can delay formal quality planning until closer to submission. This ignores QbD’s ability to help reduce the need for remediation, which is costly, and avoid delays caused by late-stage fixes.
• “It’s too disruptive.” Changing existing processes can feel risky. But skipping QbD can result in much bigger problems, like poor data quality, database delays, or regulatory rejections. 

Why Starting Early Makes a Difference 

The earlier QbD is incorporated into a trial design, the more powerful and cost-effective it becomes. MMS Holdings often hears clients say, “We don’t need that right now,” but this mindset can backfire. The truth is: 

• Starting small is perfectly acceptable and often ideal. 
• Building a roadmap early sets the stage for future scalability. 
• Early adoption helps sponsors comply with regulatory expectations and avoid submission surprises. 
   

QbD doesn’t always require massive overhauls to existing workflows, in fact that’s rare. It’s really just about taking practical steps to build smarter from the outset. Biotechs don’t need to go it alone, either. Partners like MMS can help, bringing together expertise from cross-functional teams (clinical operations, biostatistics, programming, regulatory strategy, etc.) to embed QbD at the right scale for each sponsor’s needs. This kind of cross-functional alignment is key to success, as it ensures that everyone is working toward the same goals, using the same language, and focused on the same risks. 

For MMS, this approach reinforces a culture of collaboration. With QbD, there’s less ambiguity, fewer handoff errors, and stronger continuity between teams like medical writing, data management, clinical operations, and statistical programming. 

Where QbD Adds Value 

Biotechs implementing QbD can make a noticeable impact across several areas of clinical development. Here are some examples: 

• Protocol design: Ensures alignment with critical endpoints and helps reduce protocol amendments.
• Case Report Form (CRF) design: Captures only what is essential, avoiding unnecessary complexity and burden.
• Edit checks: Targets the data that matters most, improving accuracy and reducing downstream queries. 
• Database go-live: Reduces delays by catching quality issues before lock. 
• Submission readiness: Helps ensure that the dataset and trial narrative stand up to regulatory scrutiny.

Proactive biotechs can avoid a lot of problems. For example, failure to apply QbD in the above areas can result in delays, rework, and even trial failure. On the other hand, MMS has seen many trials where, by adopting a QbD mindset early, helped sponsors to avoid rescue situations and enabled timely regulatory approvals. 

How to Get Started (Even with Limited Resources) 

For early-stage companies with lean teams, the best way to integrate QbD is to start small and bring in the right expertise. 

Here’s how to begin: 

• Engage early with experienced partners. Teams like those at MMS can help emerging sponsors understand what’s essential now versus what can scale later. 
• Use a pilot project. Even a small or simple trial can serve as a proof-of-concept for embedding QbD. 
• Educate the team. Not everyone needs to be a QbD expert, but basic understanding across functions improves implementation and alignment.
• Build a roadmap. Define where the company is now, where it’s going, and how QbD practices can evolve along the way. 

Evolving with the Industry 

QbD isn’t static. As technology advances and regulatory expectations evolve, so must the approach. 

This is why MMS continues to refine its QbD methodologies, including through the integration of advanced tools like KerusCloud. MMS also monitors emerging technologies, including AI applications, as we remain committed to ensuring our client partners have the most effective solutions available.

For Biotechs, Early Quality is a Strategic Advantage 

No sponsor wants to hear late in development that their trial is in trouble. But that can happen when quality is treated as a checkbox or an afterthought. Building QbD into the foundation of a study reduces risk while creating a path for faster, more confident trial execution. 

For emerging biotech companies, it can be overwhelming to consider making changes to long-standing processes. But the results are worth it, and with the right partners, integrating QbD can be smooth and painless, while delivering real, measurable impact on risk, costs, and timelines. 

To learn more about MMS’ solutions across the data lifecycle, click here