Optimize Your MedTech Study with high quality Biostatistics Services

Optimize your MedTech study with Veranex's high-quality biostatistics and statistical programming services, featuring extensive experience across every phase from pre-clinical through post-marketing, including protocol development, regulatory submissions, and strategic consulting.

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675

+

Studies for medtech, pharmaceutical, and biotech real‑world studies

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20

+

Years experience

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~

20

Therapeutic areas

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The Science Behind Biostatistics

In medical device trials, effective biostatistics services distinguish true effects from random variation, ensuring operational efficiency and regulatory compliance. This means faster approvals, reduced costs, and stronger evidence packages, our expertise delivers reliable results that regulatory agencies demand and investors trust.

Expert Biostatistics and Statistical Programming services designed to support your clinical trial.

Our dedicated team delivers high-quality, compliant data handling with statisticians and programmers working closely together across diverse therapeutic areas. We're scalable for any study size with native proficiency in SAS, R, Python, and Stata, backed by 10+ years of validated methodologies across diverse regulatory standards and study designs.

Data Analysis & Reporting

Analysis supporting all therapeutic areas, including cardiac safety data (pilot and thorough QTc studies)

Analysis of all study types, including observational studies

Postmarketing data analyses and reporting

Creation, review, validation, and/or interpretation of TLFs based on the Statistical Analysis Plan (SAP)

Full statistical support for Clinical Investigation Plan/Report development

Blinded/unblinded data review and analysis support

ISS (SCS) / ISE (SCE) analysis
Pharmacokinetics/Pharmacodynamics (PK/PD)
Data Standards & Conversion
Regulatory & Safety Reporting
Specialized Reports

Meet the Team

Meet Our Expert Biostatistics Services Team

Our team of biostatisticians includes experts on regulatory statistics based on previous work experience as European experts on authorisation of medicinal products, including medical devices, for human or veterinary use in the regulatory network of the EMA.

Our team has experience with publications and statistical reviews of articles in high-impact scientific journals, The Lancet journals. PLoS journals, PNAS, and others.
Beyond conventional areas of biostatistical expertise related to clinical trials, we also offer expert consulting on measurement theory, esp. Psychometrics including Patient-Reported Outcomes (PROs).

Wilmar Igl, PhD

Director, Biostatistics

Koteshwar-Govind

Koteshwar Govind

Assoc Director, Statistical Programming

Clinical Data Management

Clinical Data Management

Our clinical data management will transform your trial data into actionable insights, ensuring unparalleled accuracy, efficiency, and compliance that drive successful outcomes.

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Data Visualizations

Data Visualizations

Transform your complex clinical data into clear, impactful graphics, empowering stakeholders to easily understand trends and make informed decisions at a glance with our data visualizations.

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Regulatory Consulting

Regulatory Consulting

Accelerate Your Regulatory Submission, partner with our regulatory experts to transform your biostatistics into FDA-ready documentation

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Unlock the full potential of your clinical trials

Our dedicated team ensures high-quality data analysis, regulatory compliance, and tailored solutions to meet your study's unique needs. Partner with us today to enhance the reliability and success of your clinical research.

Analyze with Veranex