Biostatistical Consulting for Clinical Trials & Regulatory Submissions Worldwide
FDA. EMA. PMDA. Health Canada. NMPA. From regulatory submissions to pharmacogenomics in oncology and patented synthetic cohort designs, Kingfish Analytics brings world-class statistical expertise to your most critical programs.
Three emerging capabilities where Kingfish combines patented methodology, real-world evidence, and deep therapeutic expertise.
✦ Patented Methodology
Synthetic Cohort Designs Using Real-World Evidence
Kingfish has developed proprietary methods for constructing synthetic control arms and comparison cohorts from real-world data — enabling single-arm trials, regulatory-grade external comparators, and accelerated development timelines in settings where traditional RCTs are impractical.
Real-World Evidence
External Control Arms
Single-Arm Trials
RWD/RWE
🏛 3 U.S. Patents Issued
✦ NEW PRACTICE GROUP
Pharmacogenomics in Cancer & Rare Disease
Our new pharmacogenomics group brings specialized statistical expertise to precision medicine programs — designing and analyzing trials where treatment is guided by genomic biomarkers. We focus on oncology and rare disease indications where small populations demand innovative trial designs.
We pair deep methodological expertise with global regulatory
knowledge to move your product from trial to market.
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Clinical Trials
Full statistical support for U.S. and international trials — from protocol design and sample size through interim analyses, CSR reporting, and regulatory-ready deliverables.
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Healthcare Analytics
Decision analytics that combine behavioral economics, experimental psychology, and real-world evidence to understand patient and provider decision-making.
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Global Regulatory Strategy
End-to-end statistical planning for FDA, EMA, PMDA, Health Canada, NMPA (China), and other international regulatory agencies — from pre-submission meetings through marketing authorization.
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Predictive Modeling
Machine learning, data mining, and advanced regression modeling to uncover patterns and forecast outcomes from complex datasets.
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Regulatory Submissions
Statistical packages for 510(k), PMA, CE marking, and PMDA filings — including integrated summaries of safety and effectiveness, and post-market surveillance.
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Data Collection & Integration
Survey design, primary data collection, database architecture, and integration services for organizations starting from scratch or scaling up.
WHY KINGFISH
The rigor of science. The demands of regulators.
We've supported submissions to the FDA, EMA, PMDA, Health Canada, and NMPA and consulted for Fortune 500 companies — so we know how to deliver regulatory-grade work on real-world timelines.
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Multi-Disciplinary Team
Cross-trained in biostatistics, health economics, consumer psychology, and data science — so you get the right method for the problem, not the only one we know.
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Budget-Conscious Structure
Our nonprofit organization allows us to offer top-tier consulting at rates significantly below the industry standard.
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Regulatory-Grade Rigor
Our work meets the statistical standards required by FDA, EMA, PMDA, Health Canada, and NMPA reviewers. We've supported filings across drug, device, and biologics programs on five continents.
What Our Clients Say
"Kingfish didn't just run the numbers — they helped us understand what the data meant for our clinical program and gave us a clear path forward for our FDA submission."
-- Medical Device Startup CEO
Class I FDA Submission
"We needed a team that understood both FDA and EMA requirements. Kingfish delivered a statistical package that satisfied reviewers on both sides of the Atlantic."
— VP of Regulatory Affairs, Pharma
Dual FDA/EMA Filing
Results
Selected Case Studies
Real outcomes from our work across pharmaceutical, medical device,
and regulatory programs.
GLOBAL REGULATORY
Dual FDA & EMA Submission
A mid-size pharma company needed a unified statistical strategy to support simultaneous regulatory filings in the U.S. and EU — with different endpoint expectations across agencies.
Decision Analytics
Fortune 500 Customer Segmentation
Used advanced decision analytics to identify the key attributes driving sales, segment customers, and quantify trade-offs between price and quality perceptions.
Pharmaceutical
Medical Device FDA Submission
Helped a startup leverage pilot trial results to attract investors while simultaneously preparing the statistical package for their Class I FDA submission pathway.
A boutique biostatistical consultancy specializing in global regulatory submissions, pharmacogenomics, and patented synthetic cohort designs using real-world evidence.
