Biometrics Built Better

Driving Success in Complex Oncology Trials

Comprehensive biometrics support to help you deliver high‑quality, regulatory‑ready outputs and bring life‑changing therapies to patients faster.

Oncology trials are among the most complex in clinical research. With evolving biomarkers, adaptive designs, and increasingly personalized therapies, your study success depends on more than technical skill. It needs deep therapeutic insight, strategic foresight, and operational agility, areas where we excel.

From early‑phase dose escalation to global Phase III submissions, we work as an extension of your team to provide expertise in data management, statistics and programming that will keep your oncology trials moving seamlessly.

Our expertise

We’ve supported over 200 oncology studies across indications including:

Acute and chronic leukaemias (ALL, AML, CML)

Multiple myeloma and lymphomas

Myelodysplastic syndromes (MDS)

Systemic mastocytosis (SM)

Non‑small cell lung cancer (NSCLC)

Gastrointestinal stromal tumors (GIST)

Multiple solid tumors and rare cancers

Our services span the full biometrics lifecycle:

Data management (database build, data checks, data visualization, data cleaning)

Study design including protocol development, sample sizing.

SAP development

Dose escalation modelling (Bayesian designs, interval designs and 3+3)

CDISC‑compliant SDTM and ADaM datasets

TFL programming and QC

DMC support and unblinded statistical oversight

Regulatory submissions (FDA, EMA, PMDA)

Early‑Phase Support to De‑Risk and Accelerate Your Trials

With experience in 120+ Phase I/II studies, including 30+ early‑phase oncology trials, we help you make faster, safer, and smarter decisions in the earliest stages of development.

Our team brings specialist expertise in:

Bayesian dose escalation models

Product-specific study designs for immunotherapies

Managing cytokine release syndrome (CRS) risk

Rapid turnaround from database lock to reporting (often <10 days)

Protocol amendments and adaptive designs

Our modelling approaches allow for patient-specific cohorting and more confident dose selection, reducing risk and improving trial efficiency.

End-to-end Automation

Accelerate Study Success: Automate Workflows, Future-Proof Results, and Streamline Delivery

Veramed.ai

Accelerate Study Success: Automate Workflows, Future-Proof Results, and Streamline Delivery

Data Visualization

Accelerate Study Success: Automate Workflows, Future-Proof Results, and Streamline Delivery

Next Generation Standards

Accelerate Study Success: Automate Workflows, Future-Proof Results, and Streamline Delivery

CDISC

Accelerate Study Success: Automate Workflows, Future-Proof Results, and Streamline Delivery

R, Open Source & Cloud

Accelerate Study Success: Automate Workflows, Future-Proof Results, and Streamline Delivery

Our Experts

Our oncology team brings decades of hands-on experience across a wide range of oncology studies, from solid tumors and haematological malignancies to cell and gene therapies, immuno-oncology, and early-phase trials.

With an average of over 12 years’ experience, our data managers, statisticians and programmers have worked on everything from complex adaptive designs and Bayesian modelling to data lifecycle management and regulatory submissions, bringing the knowledge needed to maximize your study’s chances of success.

Our Solutions

We take pride in our collaborative approach, integrating closely with your team, proactively monitoring risks and providing transparent communication and governance to ensure consistent, high‑quality delivery across global sites.

Choose from one of our flexible solutions to match your study needs:

Strategic & Technical Consulting

Specialized guidance across statistical design, data management, programming, and technology solutions

Project-Based Solutions

Flexible, high-quality biometrics solutions to support clinical trials from start to finish.

Functional Service Provider

Powering long-term success through close collaboration and bespoke integrated solutions.

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