As a Chief Medical Officer at a clinical-stage biopharmaceutical company, you’re not just juggling science and execution of clinical trials. You’re also tasked with optimizing development timelines, mitigating risk, and maximizing ROI on every clinical decision. This pressure is heightened by board expectations, investor scrutiny given the current fundraising climate, and the urgency to bring innovative therapies to patients faster.

That’s why our Miracle team was honored to attend and speak on a panel at the 2025 Chief Medical Officer 360º Summit in Boston on April 7-8, 2025. Our CEO, Jin Kim, drew on our collaborations with cutting-edge biotech sponsors to share how stronger collaboration and smarter oversight can drive clinical trials forward faster. Beyond our session, the conference featured a wide array of insights from industry thought leaders, covering everything from protocol design to AI-driven trial optimization.

Below, we’ll highlight three broader takeaways from the summit before digging into our panel discussion and why these insights matter to anyone involved in clinical trial management and operations.

Key Takeaways

1. R&D Trends and Operational Efficiency (Keynote by Ken Getz)

• Kenneth Getz of the Tufts Center for the Study of Drug Development revealed that roughly 30% of trials fail due to operational inefficiencies, such as enrollment issues, protocol deviations, and excessive complexity.
• For many sponsors, ROI on R&D has dipped to just 2–3%, making it more important than ever to streamline trial execution—especially given the difficulty of accessing capital post-COVID.
• Protocol complexity has skyrocketed over the last decade, with the number of data points collected in Phase 3 trials quadrupling. Keeping protocols lean and focusing on essential endpoints can help reduce costs and timelines.

2. AI and Data-Driven Approaches

• Multiple sessions showcased how AI and machine learning can turbocharge site selection, patient recruitment, and real-time data cleaning, with some solutions claiming to reduce enrollment times by 40%.
• A big caveat: panelists stressed that AI can “hallucinate,” or produce misleading outcomes if data quality or oversight is lacking. Manual human review and quality checks remain critical to ensure reliability and accuracy.

3. Medical Affairs, Policy, and the Evolving CMO Role

• Medical Affairs sessions spotlighted the need for “Triple Threat” professionals: those with strong scientific expertise, business acumen, and emotional intelligence. This cross-disciplinary skill set can bolster internal collaboration and stakeholder engagement.
• Policy-oriented keynotes addressed the IRA’s “pill penalty,” Medicare coverage changes, and IP concerns. In today’s global R&D landscape, forming strategic relationships with regulators and advocating effectively on policy matters are essential skill sets for CMOs.

Recap of Panel Discussion on Clinical Operations

1. Creating a Shared Sense of Urgency

One of the biggest challenges in clinical trials is ensuring that every team—Clinical Operations, Medical, Safety, Data Management, executive leadership, and even the board—feels equally invested in hitting important milestones. A raw number, like four patient randomizations in a month, might sound fine to some and alarming to others. Translating that progress into a context that resonates with every team is crucial. For instance, providing a concrete projected finish date (e.g., January 24, 2026 vs. a target of Q3 2025) highlights exactly how far off the timeline is, prompting teams to discuss how they can help unblock barriers and correct the course.

A tangible example: By pulling actual enrollment data from your Electronic Data Capture (EDC) system and reviewing recent screening rates, screen failures, and average enrollment timelines, you can determine when to close screening to avoid overshooting enrollment. This prevents the study from remaining open longer than necessary. Then, factoring in the timeframe from Last Patient Last Visit (LPLV) to database lock (including data cleaning) yields a more accurate estimate for your topline data (TLD).

Takeaway: Use clear, tangible metrics that resonate across different functions and teams. When everyone sees precisely how behind (or ahead) the project is, it spurs action.

2. Accountability Can’t Be Outsourced

While CROs and vendors often manage day-to-day tasks, ultimate responsibility for timelines, quality, and success still rests with the sponsor. If you rely solely on their progress reports, there's always a chance that you may discover problems too late, after you’ve spent precious time and budget. Many conferences echo the frustration that “vendors sell you the A-team but gradually switch to the C-team.” To keep your trial on track, it’s vital to monitor performance consistently and verify that you always have the A-team driving your studies forward and finish on schedule.

Takeaway: Don’t let delegation become abdication. Stay closely connected to the work and hold vendors (and yourself) accountable to avoid missing key deadlines. For example, one of our clients used continuous oversight to recoup $50k in credits from their CRO by meticulously tracking data-cleaning effectiveness, site monitor visits, and overall data management performance.

3. Visibility Drives Momentum

Visibility and transparency can drastically reduce surprises and minimize blind spots, which naturally increase as your biotech team expands and cross-functional collaborations intensify. The panel shared examples of teams using iPads or TV screens in hallways to display real-time dashboards, while others embed dashboards into Microsoft Teams. Having immediate insight into potential risks and bottlenecks, rather than waiting for monthly or quarterly updates, allows you to address issues before they escalate.

From a leadership level, you may already receive neatly packaged reports in your inbox or on your desk. However, compiling those reports can be time-consuming for your team. The key is having the right processes and tools in place so that everyone can see and respond to potential challenges quickly.

Takeaway: The sooner you see a roadblock, the sooner you can solve it. Make trial progress visible and accessible to everyone, so problems don’t linger in potential blindspots.

Why This Matters Now

With the biotech fundraising landscape tightening and global events contributing to market volatility, the pressure to bring innovative therapies to market efficiently has never been greater. Meanwhile, there are growing concerns about regulatory requirements under the new administration. In this environment, efficient clinical trials aren’t merely beneficial. They’re critical to your company’s success. By prioritizing transparency, accountability, and urgency, sponsors can streamline clinical trial operations while maintaining the highest standards for patient safety and data integrity.

Looking Ahead

If you missed Jin’s session at the CMO Summit, these key points are a great place to start. At Miracle, we’re passionate about helping sponsors harness better oversight strategies and best practices to accelerate clinical trials. We believe that by bridging the gap between scientific vision and operational execution, we can help bring life-changing treatments to patients faster.‍

Stay Connected

Be sure to follow our blog for more insights on best practices in clinical trial operations, updates from industry events, and practical tips to help your team succeed. In the coming weeks, we’ll be sharing more on how Miracle can help you streamline trial oversight, manage data more effectively, and foster a truly collaborative culture.

If you have any questions or want to learn more about how Miracle can support your clinical trials, feel free to reach out here.