Clinical trials sit at the heart of medical advancement, yet they’re often hampered by paperwork, manual processes, and disconnected systems. This critical bottleneck doesn’t just slow down drug development—it directly impacts patients waiting for life-saving treatments. Sharon Kim, CEO of MPilotAI, has built a solution that’s changing how clinical documentation works. Her company’s AI platform addresses the most frustrating pain points in an industry still running on outdated tools.
Understanding the Documentation Load
Clinical trials run on paper. Lots of it. And despite all our technological advances, the process hasn’t changed much in decades. “Designing a clinical trial is one of the most high-stakes phases in drug development—and one of the most error-prone,” Sharon says. Teams juggle endpoints, eligibility criteria, dosing strategies—all while trying to keep regulators happy. The margin for error? Almost zero. Most outsiders don’t see the chaos behind the scenes. “The process is still largely manual, with decisions often made in silos and repeated across disjointed systems,” she explains. Picture smart people wasting hours fixing document versioning problems instead of solving medical challenges. That’s the reality.
Other challenges follow after approval. “Once a protocol is approved, teams face a mountain of follow-up documentation: amendments, study reports, and regulatory updates, all requiring rechecking and cross-referencing.” No wonder trials take years and cost millions. The consequences go beyond frustration. “These bottlenecks not only slow progress, but they introduce risk. Delays in submission timelines can cost companies millions and push life-saving treatments further out of reach.” Patients wait longer. Companies bleed money. Nobody wins.
Streamlining the System with MPilotAI
Sharon didn’t just identify the problem—she built a solution that fits how researchers actually work. “MPilot is a purpose-built AI platform designed to streamline the documentation process from the inside out,” she explains. The key? Working with existing tools, not against them. “We combine a secure, cloud-based environment with Microsoft Word integration, allowing users to work in familiar formats while leveraging AI in real time.”
The secret isn’t generic AI—it’s clinical expertise baked into the system. “What makes MPilot LLM different is our library of over 200 pre-engineered prompt templates built specifically for clinical trial content.” These aren’t ChatGPT prompts with a medical spin. They’re specialized tools built by people who understand the industry’s unique needs. “These prompts aren’t generic, they’re tailored to generate critical components like inclusion criteria, endpoint definitions, risk mitigation strategies, and in-text tables.” The result? Documents that satisfy both scientific and regulatory requirements without the usual headaches.
Returning Focus to Science
When you strip away the jargon, Sharon’s mission is simple: let researchers focus on research, not paperwork. “The true value of AI isn’t just in saving time—it’s in freeing up people to do what they do best,” she says. MPilotAI handles the document chaos so clinical teams can focus on what matters—developing treatments that work. The whole system is built with security as the foundation. “Everything is designed with data security and compliance in mind, ensuring that automation doesn’t compromise integrity.” In an industry where trust is everything, that matters.
Sharon sums it up perfectly: “When researchers and medical writers aren’t stuck managing repetitive tasks, they can focus on higher-level strategy, scientific rigor, and innovation. That’s what leads to stronger submissions, faster approvals, and better outcomes for patients.” After all, patients don’t care about perfect documentation. They need treatments that work, delivered as quickly as science allows. “Because in this space, quality isn’t a luxury; it’s a requirement.”
MPilotAI keeps working to simplify the complex world of clinical documentation. As Sharon puts it: “We’re building tools that take the complexity out of clinical documentation so your team can focus on what matters most.” For an industry drowning in paperwork, that’s exactly what the doctor ordered.
Connect with Sharon Kim on LinkedIn to follow how MPilotAI is transforming clinical documentation.
