🇨🇭 Swiss Data Privacy & Precision

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.

ISO 27001 SOC 2 FDA 21 CFR Part 11 GDPR & HIPAA

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.

SAP

Statistical analysis plans

Statistical analysis plans (SAP) define the foundation for all statistical programming and regulatory submission outputs.

  • Definition of analysis populations and endpoints
  • Specification of statistical methodologies
  • Planning of interim analyses
  • Alignment with regulatory guidance and submission requirements
  • Documentation of randomization methodology and planned allocation approach

CDISC

CDISC‑compliant dataset generation

Our CDISC dataset generation services include study data tabulation model (SDTM) datasets, analysis data model (ADaM) datasets, CDISC mapping services, and Define.xml generation for regulatory submission.

  • SDTM datasets with validated mapping and aligned metadata
  • ADaM datasets generation and validation
  • CDISC mapping services ensuring traceability
  • SDTM Define.xml generation and validation
  • Dataset validation and compliance checks, including traceability and Pinnacle 21 checks
  • Annotated case report form (aCRF) development ensuring clear variable‑to‑dataset mapping

Outputs

Submission‑ready outputs

Submission-ready statistical programming outputs aligned with FDA, EMA, and global regulatory expectations.

  • Programming of all statistical outputs using SAS (Statistical Analysis System), SPSS (Statistical Package for the Social Sciences), and R (R Statistical Computing Environment)
  • Submission‑ready TLFs (Tables, listings, and figures) and regulatory datasets formatted for FDA/EMA review
  • Statistical analysis reports prepared for regulatory and clinical interpretation
  • Regulatory submission datasets structured for seamless FDA/EMA review
  • Documentation packages compiled to support audits, inspections, and reviewer guidance
  • Publication‑ready tables and figures for clinical and scientific communication

Leadership Perspective

Expert perspective

"Simplify. Remove the unnecessary so that the necessary may speak."
Urosh Vilimanovich, PhD
Chief Customer Officer

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

Centinel Spine logo
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

Oxular logo
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

Appletree CI Group AG logo
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

Marti Farm Ltd logo
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

Polpharma SA logo
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

Velocious Clinical Research logo
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

Our Expertise

Proven biostatistics and statistical programming expertise

Explore Oomnia

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

Blog

Wemedoo returns to Xraised episode 2 with unified data in focus

July 9, 2026

Blog

Artificial Intelligence in Clinical Trials: Balancing Innovation and Accuracy

June 24, 2026

Blog

A new scientific publication featuring Wemedoo researchers has been published in BMC Medical Research Methodology

June 24, 2026

Blog

The CRO’s Guide to Winning Sponsor Trust

June 24, 2026

Blog

Key Takeaways from EUCROF25: AI, Integration, and CRO Challenges in Clinical Trials

June 24, 2026

Blog

Wemedoo Becomes an Associate Member of EUCROF

June 24, 2026

Blog

Across Global Alliance Selects oomnia as a Central Trial Infrastructure

June 24, 2026

Blog

Revolutionizing Clinical Trials: How Wemedoo is Accelerating Global Research

June 24, 2026

Blog

Why does unified data matter? Hear from Wemedoo at Swiss Biotech Day!

June 24, 2026

Blog

Wemedoo in The CEO Magazine: Fixing Clinical Trials

June 24, 2026

Blog

Wemedoo in Forbes: From Clinical Frustration to Real Innovation

June 24, 2026

Blog

New Era of Clinical Trials with oomnia®: Built for Complexity, Designed for Simplicity

June 24, 2026

Blog

Dr. Nikola Cihoric elected to EUCROF AI Expert Group

June 24, 2026

Blog

Wemedoo announces strategic partnership with mediri to streamline imaging data management in clinical trials

June 24, 2026

Blog

Wemedoo’s innovation journey with oomnia on Xraised

June 24, 2026

Blog

The hidden cost of disconnected systems in biotech and the path to streamlined trials

June 24, 2026

Blog

Wemedoo receives SCDM innovator start-up of the year 2025 award

June 24, 2026

Blog

Wemedoo featured on BioSpace

June 24, 2026

Blog

Wemedoo joins Xraised again to share new perspectives

June 24, 2026

Blog

Wemedoo featured on AP News

June 24, 2026

Blog

Clinical trial trends in 2025

June 24, 2026

Blog

Why eClinical architectures have reached their limits, and a new category is emerging

June 24, 2026

Blog

Why compliance risk increases in modular eClinical setups

June 24, 2026

Blog

What makes a clinical trial software truly unified

June 24, 2026

Blog

Top EDC software solutions for clinical trial teams

June 24, 2026

Frequently asked questions (FAQ)

What are biostatistics services in clinical trials?

Biostatistics services in clinical trials include statistical planning, analysis, and reporting of clinical study data. Wemedoo provides biostatistics services including statistical analysis plan (SAP) development, sample size calculations, interim analyses, final statistical analyses, and submission-ready outputs using SAS, SPSS, and R programming.

At what stage does Wemedoo provide biostatistical support?

Wemedoo provides biostatistical support at every stage from protocol development through regulatory submission. This includes sample size calculations during study design, randomization planning, interim analyses during conduct, final analysis after database lock, and statistical expert support during regulatory reviews.

How does Wemedoo ensure reliability of statistical analysis results?

Wemedoo ensures statistical reliability through independent programming verification (double programming), validated SAS, SPSS and R environments, peer review of all statistical outputs, compliance with ICH E9 guidelines, and experienced biostatisticians who apply sound statistical methodology.

How long does statistical analysis take after database lock?

Statistical analysis timelines after database lock depend on study complexity, but Wemedoo's experienced team and established processes enable efficient turnaround. Timelines are defined in the SAP and project plan, with typical analyses completed within weeks of database lock.

What statistical programming outputs does Wemedoo deliver?

Wemedoo delivers submission-ready statistical outputs including tables, listings, and figures (TLFs), annotated CRFs, statistical analysis plans, clinical study reports statistical sections, SDTM and ADaM datasets, define.xml files, and reviewer's guides for FDA and EMA submissions.

What is CDISC compliance in clinical trials?

CDISC (Clinical Data Interchange Standards Consortium) compliance means clinical trial data is organized and formatted according to internationally recognized standards required by regulatory agencies. This includes SDTM (Study Data Tabulation Model) for raw data, ADaM (Analysis Data Model) for analysis-ready datasets, and associated metadata documentation.

What CDISC services does Wemedoo provide?

Wemedoo provides comprehensive CDISC services including SDTM dataset generation, ADaM dataset creation, CDISC mapping specifications, define.xml generation and validation, annotated CRF preparation, reviewer's guide authoring, and Pinnacle 21 (OpenCDISC) validation to ensure submission-ready data packages.

Why is CDISC compliance important for regulatory submissions?

CDISC compliance is required by the FDA for all new drug applications (NDAs) and biologics license applications (BLAs), and increasingly expected by the EMA and PMDA. Submitting data in CDISC format ensures regulatory reviewers can efficiently analyze study data, reducing review timelines and queries.

What types of regulatory submissions does Wemedoo support?

Wemedoo supports CDISC-compliant data packages for FDA NDAs and BLAs, EMA marketing authorization applications, PMDA submissions, and other global regulatory filings. The team ensures datasets meet the latest CDISC implementation guides and regulatory requirements.

How does Wemedoo handle CDISC mapping for complex studies?

Wemedoo handles complex CDISC mapping through experienced programmers who develop detailed mapping specifications, apply therapeutic area standards where applicable, manage non-standard variables through supplemental qualifiers, and validate all datasets using Pinnacle 21 before submission.