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.
Proven Track Record in Statistical Excellence:

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

Years experience

Therapeutic areas

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.
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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
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Pharmacokinetics/Pharmacodynamics (PK/PD)Support for PK/PD parameter calculations
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Data Standards & Conversion
CDISC services: SDTM, ADaM, Define.XML, Reviewer’s Guide
Mapping and conversion of legacy study data to current 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, DSMB)
Support with regulatory submissions, queries, and reporting for DSUR, PSUR, and 120-day safety updates
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Specialized ReportsPatient profile reports
PD listings
BIMO listings
Narratives
A history of excellence
We've provided SAS programming for 4 of the top 7 CROs along with 3 of the top 5 global life science companies.




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Meet the Team
Meet Our Expert Biostatistics 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
Wilmar Igl, PhD, is a medical statistician, psychologist and former researcher at the interface between statistics, data science, and life sciences with over 23 years of professional experience. At VERANEX (Stockholm, Sweden), he holds the position of Director of Biostatistics, in which he is leading a team of biostatisticians. Previously, he worked in a similar role as Biostatistics Consulting Director at ICON PLC (2022-2024). As a statistical assessor at the Swedish Medical Products Agency between 2018 and 2022, he collected extensive experience regarding regulation of drugs, biologics, medical devices within the EMA regulatory network. He also worked for large pharma companies in various technical (consulting) roles at the interface between statistics and scientific computing at Bayer Pharma (Berlin, Germany, 2010-2012) and at AstraZeneca (Cambridge, UK, 2015 – 2017). His main interests include clinical trial designs (including adaptive designs), Bayesian statistics, patient-reported outcomes, open-source software, and statistical programming.
Koteshwar Govind
Assoc Director, Statistical Programming
Koteshwar Govind brings over 20 years of expertise in clinical statistical programming and data management. As Associate Director at Veranex, he plays a pivotal role in strategic planning and execution of deliverables tailored to client needs. He holds a Master’s degree in Statistics and has extensive experience in standardizing clinical data into SDTM and ADaM datasets in accordance with regulatory guidelines. He also oversees resource allocation, ensuring the right talent is assigned to drive project success. His leadership supports the delivery of high-quality, compliant data solutions for global clinical trials.
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Related Services at Veranex
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.

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.

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

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.



