Professional Services for Clinical Trials
Biostatistics services and statistical programming
Wemedoo is a CDISC member, supporting standardized clinical data and regulatory-compliant dataset generation. From study design to regulatory delivery, our biostatistics and programming experts provide validated analytical methods, standardized SDTM/ADaM datasets, and reporting documentation built for FDA and EMA submission.
What We Do
End-to-end biostatistical support across every trial phase
Defining endpoints and selecting appropriate analytical methods for clinical trials
Calculating sample size to achieve the required statistical precision
Designing adaptive studies that support controlled, data-guided adjustments
Performing interim analyses and statistical monitoring
Statistical programming of tables, figures and data listings
Data Safety Monitoring Board (DSMB) meetings
Delivering final analyses and regulatory reports
Randomization design and implementation
Core Capabilities
What Wemedoo's biostatistics and statistical programming services include
Our clinical biostatistician services define the statistical direction of each trial, ensuring methodological rigor, validated analysis plans, and CDISC-compliant datasets for biotech, pharma, and research organizations.
Leadership Perspective
Expert perspective
"Simplify. Remove the unnecessary so that the necessary may speak."
Regulatory Compliance
Regulatory‑aligned biostatistics and CDISC‑compliant data outputs
Compliance with FDA and EMA statistical expectations
Adherence to ICH E9 statistical principles
Analysis plans and statistical methods aligned with ICH E9 requirements for clinical trial design and analysis
CDISC standards across SDTM, ADaM, and Define.xml
CDISC standards applied across SDTM, ADaM, and Define.xml metadata for every regulatory submission
Consistent SDTM and ADaM structures
Consistent SDTM and ADaM structures supported by clear mapping rules and controlled metadata
Multi‑layer validation and traceability checks
Multi‑layer validation and traceability checks across statistical, clinical, and programming domains
Audit trails and validated environments
All outputs are supported by traceability, audit trails, and validated programming environments
FDA and EMA submission readiness
Regulatory submission datasets and documentation structured to meet FDA, EMA, and global authority expectations
Who We Support
Who our biostatistics and statistical programming services support
Biotech organizations planning or executing multi‑phase trials
Growing pharma teams needing end‑to‑end analytical and data cleaning support
Sponsors transitioning between CROs who require stable, consistent analysis workflows
Companies addressing analytical discrepancies or requiring re‑analysis
Academic institutions relying on structured, reliable biostatistical expertise
Client Testimonials
Collaboration built on trust and innovation
Wemedoo's technology, expertise, and intimate engagement with our team in the development of the EDC, site/patient interface, and metric capabilities are unique. They provided insight and challenged the underlying assumptions to ensure the study's goals and objectives were clearly defined and the operating structure matched with the study's intent. Their system is not a one-size-fits-all and they adapt to the needs of the sponsor, sites, physicians, and the study requirements into a system that merges health information/data and can then become not only informative but actionable.
James Kuras
Vice President of Clinical Affairs and Operations at Centinel Spine
Wemedoo's cross-functional, integrated teams capture EDC set-up, go-live, data capture, data cleaning, and finally data analysis in a globally compliant fashion supporting trials in different geographies including the US. Their speed of addressing customer needs sets in my personal experience industry benchmark whilst keeping these data solutions lean and affordable. Besides the great proprietary systems they use, their integrated team approach with personal responsibility and honest commitment to targeting outcomes differentiates the Wemedoo team from other providers. Wemedoo only made Oxular's key initial trial, a device-drug trial possible, as based on some pre-work, the Wemedoo team could substantially adapt and update the first EDC ideas for a trial under a US FDA IND. The Wemedoo team worked extremely focused on familiarizing US trial sites and clinical CROs with the use of their system, which turned out to be a key success factor of the respective trial. The highly professional and up-to-date capabilities in data sciences were mirrored by customer-centricity and super fast timelines of integrating mandatory adaptations to the data systems.
Friedrich Asmus
Former Chief Medical Officer at OXULAR
All jobs, both large and small, are performed with the same dedication to quality, detail, innovative thinking, and rigor. It is always a pleasure to work with the Wemedoo team.
Georg Mathis, PhD
CEO at Appletree CI Group AG
Wemedoo embodies all the traits desired in a partner in the clinical trial industry – expertise, innovation, reliability, compliance, and attention to detail.
Martina Diminic Smetisko, DMD
Managing Director at Marti Farm Ltd
Their dedication to, and support of, our projects has resulted in clear quality deliverables. They are always there to answer any questions with expertise in a timely manner. I am looking forward to our next project together.
Volodymyr Stus, MD
Biopharmaceutics and Clinical Research Department Manager at Polpharma SA
Complex adaptive trials demand speed, precision, and system stability. With oomnia, Wemedoo's unified clinical trial software maintained continuous drug supply oversight, real-time data capture above 99%, and zero Randomization and Trial Supply Management (RTSM) dispensing errors throughout the study. The study reached database lock within 3 days after Last Patient Last Visit (LPLV), a direct result of integrated EDC–RTSM execution and proactive technical support. Wemedoo's technology and team responsiveness played a key role in meeting aggressive milestones.
Dhiraj Patel, Dr.
Director at Velocious Clinical Research
Experience across Phase I–IV clinical trials
Expertise in SDTM, ADaM, and Define.xml generation
Proven delivery of submission-ready CDISC datasets
Collaboration with global sponsors and CROs
Publication ready reports
Resources
Biostatistics & programming resources
Biostatistics & Programming
Wemedoo returns to Xraised episode 2 with unified data in focus
July 9, 2026
Artificial Intelligence in Clinical Trials: Balancing Innovation and Accuracy
June 24, 2026
A new scientific publication featuring Wemedoo researchers has been published in BMC Medical Research Methodology
June 24, 2026
The CRO’s Guide to Winning Sponsor Trust
June 24, 2026
Key Takeaways from EUCROF25: AI, Integration, and CRO Challenges in Clinical Trials
June 24, 2026
Wemedoo Becomes an Associate Member of EUCROF
June 24, 2026
Across Global Alliance Selects oomnia as a Central Trial Infrastructure
June 24, 2026
Revolutionizing Clinical Trials: How Wemedoo is Accelerating Global Research
June 24, 2026
Why does unified data matter? Hear from Wemedoo at Swiss Biotech Day!
June 24, 2026
Wemedoo in The CEO Magazine: Fixing Clinical Trials
June 24, 2026
Wemedoo in Forbes: From Clinical Frustration to Real Innovation
June 24, 2026
New Era of Clinical Trials with oomnia®: Built for Complexity, Designed for Simplicity
June 24, 2026
Dr. Nikola Cihoric elected to EUCROF AI Expert Group
June 24, 2026
Wemedoo announces strategic partnership with mediri to streamline imaging data management in clinical trials
June 24, 2026
Wemedoo’s innovation journey with oomnia on Xraised
June 24, 2026
The hidden cost of disconnected systems in biotech and the path to streamlined trials
June 24, 2026
Wemedoo receives SCDM innovator start-up of the year 2025 award
June 24, 2026
Wemedoo featured on BioSpace
June 24, 2026
Wemedoo joins Xraised again to share new perspectives
June 24, 2026
Wemedoo featured on AP News
June 24, 2026
Clinical trial trends in 2025
June 24, 2026
Why eClinical architectures have reached their limits, and a new category is emerging
June 24, 2026
Why compliance risk increases in modular eClinical setups
June 24, 2026
What makes a clinical trial software truly unified
June 24, 2026
Top EDC software solutions for clinical trial teams
June 24, 2026