The Bottleneck Holding Research Back
Ask anyone in clinical development what slows them down, and they’ll point to study builds. Converting complex protocols into EDC systems can take three to six months, often requiring specialized programmers and endless manual edits. Meanwhile, every day a blockbuster therapy is delayed can cost $1–8 million in lost opportunity, according to the Tufts Center for the Study of Drug Development.
This inefficiency isn’t just frustrating. It’s a wall between patients and life-saving treatments.
AI Is Already Changing the Game
Clinical research has reached a breaking point. Global R&D spending jumped nearly 50% in the past decade, but drug approvals stagnated, a phenomenon often called Eroom’s Law. AI is one of the few levers powerful enough to bend that curve.
And it’s no longer hypothetical. A recent Applied Clinical Trials report found that organizations using AI/ML saw 18% reductions in cycle time and up to 75% gains in patient monitoring efficiency. Regulators are taking notice too and the EMA recently cleared an AI tool, AIM-NASH for evaluating fatty liver disease in trials, marking a milestone for AI-powered endpoints.
Enter clinexa
At DPharm 2025, we’re unveiling Clinexa, the first AI Copilot built to take the most painful bottleneck in research, protocol to database, and make it disappear.
Here’s what makes Clinexa different:
- Protocol to Database in Days → clinexa reads and interprets protocols , auto-creating study objects leveraging CDASH and SDTM industry standards.
- Smarter Data Quality → Autogenerated edit checks based on NLP increase data quality
- Do More with Less → eliminate the tedious time-consuming parts of the study build allowing your SMEs to spread their expertise across multiple trials.
- Audit-Ready Documentation → Test cases, validation data, and compliance reports generated automatically.
- Data Sovereignty → Your trial data is never monetized to train external AI models.
Why DPharm Matters
DPharm has always been about disruptive innovation. It’s where new ideas challenge the status quo. Launching clinexa here signals something bigger than a product release, it’s the start of a new era where trial builds are measured in days, not months.
Stop by Booth 703 to see it for yourself.
A Voice from the Team
“Clinical teams asked for a smarter way to move from protocol to go-live without the costly delays due to manual efforts, testing cycles and documentation generation,” said Laura Acosta, VP of Product Management, Clinical Division at Anju Software. “With clinexa, sponsors and CROs can launch trials faster, reduce costs, and focus on getting therapies to patients.”
The Bigger Picture
AI in clinical research is no longer an experiment. It’s the edge. Companies that embrace it will lead. Those that don’t will be left behind, like Kodak ignoring digital cameras or Blockbuster dismissing streaming.
clinexa isn’t just another tool. It’s a turning point. By eliminating one of the industry’s most expensive and time-consuming bottlenecks, it accelerates innovation where it matters most — getting treatments to patients faster.
Will you be part of the future of trial builds? Join us at DPharm 2025 and see Clinexa live at Booth 703.
Images used under license by https://stock.adobe.com/
Authored by Laura Acosta, VP of Product Management, eClinical Division and Loren Sabek, Marketing Strategist
Laura Acosta, VP of Product Management for Anju’s eClinical Division, brings over 25 years of experience in life sciences software, including significant roles at Oracle Health Sciences. With academic credentials from Boston University and Tufts University in Computer Science, Laura excels in navigating the complexities of eClinical solutions. Her commitment to continuous learning and innovation has earned her recognition as a trusted leader in the field. Connect with Laura on LinkedIn to explore her expertise further.
Loren Sabek combines a strong academic foundation in biomedical sciences and psychology with a master’s degree in medical science to bring a multidisciplinary perspective to healthcare communication. Her work in the health technology sector spans clinical trial software, pharma solutions, and medical affairs platforms, where she has developed strategies that connect scientific innovation with policy, ethics, and patient impact. Connect with Loren on LinkedIn to explore her work further.