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Next-generation therapies demand a next-generation R&D partner.

The Innovation CRO advantage of Veranex is purpose-built to overcome the unique challenges of combination products, drug delivery systems, and companion diagnostics. We solution-engineer with you to power your product from concept through commercialization.

Move vision to velocity. Turn risks into results. Deliver measurable patient impact.

Explore our Solutions

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Clinical trials demand more than data collection.

They require disciplined execution that transforms site information into evidence regulators trust. Veranex powers some of the industry’s biggest CROs and biopharma sponsors, translating site data into compelling, accurate, submission-ready evidence from Phases I–IV.

Clean data. Clear insights. Confident submissions.

Explore our Services

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Veranex Biopharma represents our dedicated focus on advancing new therapies, diagnostics, and delivery systems for biopharma innovators.

Behind every breakthrough is the full force of Veranex, the Innovation CRO built to bridge visionary science and market reality with proven expertise, agile execution, and an unwavering commitment to patient impact.

One company. Full integration. Biopharma breakthroughs accelerated.

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Biostatistics Services That Deliver Results

Our global team of statisticians and statistical programmers bring deep pharmaceutical expertise to accelerate your clinical trials from protocol design through regulatory submission. 
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Therapeutic areas

250
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Global Clients

675
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Pharmaceutical biotech & medtech real‑world studies

Why Trust Us

Experience-Driven Excellence in Every Analysis

Veranex’s biostatistics and statistical programming excellence is rooted in over 20 years of proven expertise that began with Quartesian, providing high-quality statistical design, analysis, and reporting solutions that empower global pharmaceutical and biotech clients across all stages of clinical development.

 

From Protocol to Approval: Biostatistics Services That Accelerate Drug Development

Planning

Strategic Statistical Foundation

Strategic Statistical Foundation

Biostatistics drives pharmaceutical success by designing robust clinical trials that separate therapeutic signal from statistical noise. Our biostatisticians ensure your drug development studies are operationally efficient, scientifically rigorous, and regulatory compliant from the start.

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Analysis

End-to-End Statistical Expertise

End-to-End Statistical Expertise

From initial clinical scenario evaluation and sample size determination through protocol development and data analysis, our statisticians and statistical programming teams contribute specialized expertise at every phase of your pharmaceutical development journey.

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Approval

Submission-Ready Results

Submission-Ready Results

Our biostatistics services deliver reliable, valid results that regulatory agencies trust. With deep knowledge of FDA, EMA, and global submission requirements, we ensure your statistical analyses support successful drug approvals and faster patient access.

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Accelerating Drug Development Through Statistical Excellence

At Veranex, we deliver specialized Biostatistics and Statistical Programming services that accelerate pharmaceutical and biotech drug development. Our  global team ensures your clinical data meets the highest standards of quality and regulatory compliance, from first-in-human studies through post-market surveillance.

Powering Data Science in Drug Development

Advanced Technical Capabilities Our statistical programming team demonstrates native proficiency across major statistical platforms, for example, SAS and R, providing flexibility for your drug development requirements. Our capabilities are enhanced by a comprehensive repository of validated methodologies and standardized programming frameworks, developed through more than 20 years of successful pharmaceutical project delivery.

Data Analysis & Regulatory Reporting

  • Analysis of all therapeutic areas and study types, including observational (post-marketing) studies
  • Creation, review, validation, and interpretation of Tables, Listings, and Figures (TLFs), based on Statistical Analysis Plans (SAP)
  • Full statistical support for Clinical Study Report development
  • Blinded/unblinded data review and analysis support
  • ISS (SCS) / ISE (SCE) analysis for integrated submissions
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Pharmacokinetics/Pharmacodynamics (PK/PD)

  • Advanced PK/PD parameter calculations and modeling
  • Population PK modeling for dose optimization
  • Exposure-response analyses



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Data Standards & Regulatory Compliance

  • CDISC services: SDTM datasets, ADaM datasets, Define.XML, Reviewer's Guide
  • Mapping and conversion of legacy study data to current regulatory standards
  • Programming support for data pipelines EHR /EDC/ePRO integrations



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Regulatory & Safety Reporting

  • Statistical and programming support for Data Monitoring Committees (DMC), and Data Safety Monitoring Boards (DSMB)
  • Regulatory submission support, queries, and reporting for DSUR (Development Safety Update Report), PSUR (Periodic Safety Update Report, and safety updates
  • Patient profile reports, BIMO (Bioresearch Monitoring Program) listings, and regulatory narratives

 

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Biostatistics Consulting & Strategy

Our biostatistics team provides the statistical foundation for successful drug development programs. We deliver clinical scenario evaluation, innovative trial designs, and advanced statistical modeling that maximize your chances of regulatory success while optimizing operational efficiency.
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Study Design & Planning

  • Protocol development and review, including statistical sections and regulatory strategy
  • Sample size estimation and power calculations optimized for drug development
  • Randomization methodology and allocation strategies
  • Statistical Analysis Plan (SAP) development and mock shell creation
  • RTSM support and randomization implementation
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Advanced Data Analysis & Interpretation

  • Sophisticated analyses supporting all therapeutic areas, including complex endpoints
  • Blinded/unblinded data review with strategic recommendations
  • Expert interpretation of TLFs and clinical findings
  • Advanced PK/PD analyses and exposure-response modeling
  • Meta-analyses and publication support for market access
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Regulatory & Strategic Support

  • Expert consulting for DMC, DSMB and interim analyses
  • Strategic representation at global regulatory agency meetings
  • Regulatory submission strategy and statistical sections

Meet Our Expert Biostatistics Team

Leaders in Regulatory Statistics and Consulting
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Wilmar Igl, PhD

Director,
Biostatistics
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Koteshwar Govind

Assoc Director,
Statistical Programming
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Serhii Voievutskyi

Sr Director, 
Statistical Programming
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Expand Your Biostatistics Success

Turn Clinical Data into Drug Approvals with Veranex's Expert Biostatistics Team. We deliver precision statistical programming and CDISC-compliant biostatistics solutions that accelerate regulatory submissions and bring breakthrough pharmaceutical therapies to patients faster.
Innovate with Veranex