June 2025
Over the past decade, advances in AI, omics, and automation have dramatically accelerated early-stage research, speeding up target discovery, compound screening, and preclinical modelling. But the pace of development hasn’t kept up. Today, the bottleneck in biopharma isn’t just scientific; it’s operational: the pace and complexity of clinical trials. Most would argue that development has now become the bigger bottleneck.
Trials are constrained by shortages of participants and critical site professionals, outdated workflows, and manual documentation, all of which stretch timelines, inflate costs, and overload both site and central teams.
In 2024, the average R&D cost to bring a drug to market was $2.2bn, up 165% since 2014. Clinical trials account for 68% of that spend. A new asset takes over 100 months to get through all phases of clinical trials. And only 5% make it through.
For sponsors and CROs, whether biotech or pharma, the burden is immense: they carry the financial and operational responsibility for trial delivery, while also ensuring quality, oversight, and regulatory compliance at every stage.
Longer trials, slower approvals, delayed access for patients.
We are building Cori to change that. A platform that pairs AI with a team of engineers, clinicians, and regulatory experts to help sponsors and CROs run faster, higher-quality trials, and improve the entire clinical development process.
Rebuilding the Foundation of Clinical Trials
We’ve spent the last decade building AI systems across complex, high-stakes domains. For the past five years, that’s included clinical trials. Working inside global pharma, we’ve seen how fragmented processes and slow decision cycles sit at the core of quality risks, regulatory delays, and operational bottlenecks.
A single trial can generate over 1,000 documents: protocols, consent forms, study reports, and more. And a protocol alone can stretch to 150 pages and take up to 12 months to complete, before recruitment even starts. These aren’t passive records, but the source of truth across functions, systems, and regulators. And they’re still mostly created and maintained manually, requiring weeks of coordination to reconcile feedback and incorporate regulatory changes.
One error can mean resubmissions, CAPAs, or delays in patient enrollment. One day of delay can cost $800,000 in lost revenue and $40,000 in daily trial costs. It’s no surprise that the majority of trials miss key milestones. All of this starts in the Clinical Trial Enablement – Before First Patient In.
Building from the Start
This phase is where key decisions are made and timelines are defined. It’s also where many downstream challenges can be traced. When it's poorly executed, rework, delays, and compliance risks ripple through the trial. When done right, it creates conditions for smoother operations, faster execution, and better patient outcomes.
Cori exists to make that early phase work better, for everyone involved. We focus on the decisions, materials, and coordination required to get a trial moving with speed and confidence. That’s why we're starting with the core building blocks, the foundational content and coordination that determine how fast and effectively a trial can begin.
Our platform does four things:
Author – Transforms your trial concept into a complete and compliant study setup. From protocol to submission-ready content, Cori helps teams write with accuracy, speed, and regulatory confidence.
Verify – Reviews your trial materials for alignment with regulatory, ethical, quality, and patient standards. Tracks SOP compliance and highlights cross-document inconsistencies before they become issues.
Amend – Applies updates and regulatory changes across all study content instantly. Reduces rework and ensures consistency from start to finish.
Manage – Supports coordination across teams and timelines. Helps you monitor progress, manage input, and align contributors from design through submission.
Think of Cori as your AI-powered assistant, helping turn your trial concept into a fully operational study. It supports everything from drafting robust protocols to checking alignment across key documents, assessing the impact of changes, and surfacing issues like increased patient burden or regulatory gaps, early, before they cause delay. And it meets you where you are, integrating directly with the tools you already work with, like Word and Veeva.
By removing ambiguity, reducing manual effort, and improving collaboration, Cori helps sponsors get to site activation quicker and with fewer setbacks along the way. The result is up to 40% faster trial setup and fewer errors that compound into major delays later.
And we’re just getting started. From clinical operations to quality and regulatory oversight, we’re rebuilding the infrastructure that modern trials need, so sponsors can scale quickly, run safer studies, and create more time for what matters most: patients.
Purpose-Built Intelligence
You might ask, “Why not just use ChatGPT?” You could. But out-of-the-box language models weren’t built for clinical trials. They don’t understand how trials actually work, the operational flow, regulatory logic, or patient and site realities. They lack the structure, reasoning, and safeguards needed to support real-world trial execution. That’s where Cori is different: purpose-built to reason across the full trial context, not just produce compliant-sounding text.
Cori is purpose-built for clinical trials. That means two things:
Built for the domain: Our platform is designed specifically for the complexity of clinical development – from protocol authoring to amendments, cross-document consistency, and regulatory compliance. It’s not a generic writing tool retrofitted for pharma; it’s built from the ground up for trial workflows.
Tailored to your trial: Cori isn’t just trained on the clinical domain, it adapts to your trial’s protocol, design, geography, and documentation. It tracks interdependencies between documents, flags alignment gaps, and applies the relevant regulatory logic based on your indication, region, and SOPs. What you get is not generic output – but a system that reasons over your setup.
Secure by design: Your data stays private and protected. It is encrypted, never used to train models, and only accessible on a strict need-to-know basis. Cori meets the security and privacy expectations of sponsors, CROs, and regulators from day one.
Human insight still drives the decisions that matter most. But AI accelerates them.
And by integrating with existing platforms like the CTMS, EDC, and eTMF, pulling in sponsor-provided documents and data, and connecting to external sources like FDA databases, PubMed, Citeline, GlobalData, and public trial benchmarks, our system learns and improves continuously, always with full context of the trial, from setup to close.
Expanding the Market
We’re not just focused on the writing of individual documents, but on the system-level efficiency of the whole process. By rebuilding development from the ground up, we can shorten timelines and reduce the burden on sites, making the whole process simpler, faster, and cheaper, and in doing so, open up the drug development market.
Today, only the largest companies can afford the long, expensive march to market. If we reduce the time and cost of running trials, we open the door for smaller pharma and biotech firms to compete and, ultimately, increase patient access to new treatments.
And speed matters, not just for patients. First-to-market drugs capture, on average, 40% of class sales a decade after launch, which is more than double the market share of the third entrant and twenty times that of the sixth. Even fast followers can carve out a competitive edge. Cori helps all players navigate the complexities of clinical trials more efficiently and complete trials with less delay, lower cost, and fewer errors, ultimately getting more drugs to market faster.
*Percentages represent the average market share within each drug class for products with a given order of entry, not a cumulative total across all classes. Values are not meant to sum to 100%.
Empowering Today's Trials: Intelligent Tools for Faster, Smarter Research
The landscape of clinical development is undergoing a significant redefinition. While the ambition to dramatically shorten overall drug development timelines from years to months is a key industry driver, crucial advancements are already being made in specific phases. Intelligent automation, the ability to harness insights from unstructured data, and applied AI are no longer distant concepts, they are actively reshaping how clinical trials are designed, documented, and executed today. Cori is built to bring these advancements to the forefront of trial enablement, not by replacing invaluable clinical teams, but by equipping them with more powerful and intuitive tools.
We see that clinical study teams today are frequently burdened by the manual overhead of formatting documents, meticulously chasing feedback, and rectifying avoidable mistakes. Cori is engineered to alleviate these pressures. By handling these labor-intensive tasks, we empower researchers, clinical operators, and sponsors to dedicate their expertise where it delivers the most value: designing smarter studies, achieving milestones with greater predictability, and ultimately, accelerating the journey of new treatments to the patients who await them.
Let’s work together to make clinical trials better, right from page one.
The Founders
Jorn Jansen Schoonhoven, Co-founder & CEO, has a decade of experience in AI and data science, from development to venture capital. In his first seven years, he built AI products ranging from health policy classifiers to MOD data infrastructure. For the past three years, he has been an investor in AI startups.
Patricio Fernandez, Co-founder & CTO, has 10 years of experience in developing AI products, including five years focused on pharma and clinical trials, and leading AI teams at Sanofi and AstraZeneca.