ABOUT US

Quality outcomes require collaboration, trust and teamwork.

Clinical Data Experts with Proven Clinical Development Experience

PureCDM was built on a strong foundation specialising in clinical data management. Today, the company has evolved to provide integrated clinical data and biometric support across advisory, clinical data management, biostatistics, and pharmacokinetics.

With 15 years of PureCDM brand recognition and a management team with more than 25 years of broad expertise across therapeutic areas, medical devices, and Phase I to Phase III clinical trials, PureCDM brings experienced, practical, and scientifically grounded support to clinical development teams.

We work with biotech and medtech clients who need more than technical execution – they need a partner who understands how study design, data quality, statistical planning, and clinical interpretation connect to regulatory, investor, and commercial decision-making.

Our Approach

At PureCDM, we focus on early risk identification, clear communication, practical delivery, and decision-ready outputs. Our role is to help clients strengthen study planning, protect data quality, improve analysis readiness, and generate evidence they can trust.

Our Expertise

PureCDM supports studies across clinical development stages, therapeutic areas, and medical device programs. Our management team brings broad industry experience and practical insight into the challenges sponsors and partners face when planning, executing, analysing, and reporting clinical studies.

Our Value

PureCDM helps clinical development teams move forward with greater confidence by aligning data management, statistical planning, pharmacokinetic insight, and advisory expertise across the study lifecycle.

Collaboration and Trust

PureCDM is an Australian owned private company specialising in the provision of Study Design, Biostatistical Advisory, Programming and Analysis, Clinical Data Management solutions and the deployment of eClinical solutions.

We have built a unique customer-centric business model to address the specific biometrics needs of the growing local and global biotechnology sector.

Collaboration and trust are the cornerstones of our core values and are critical to the success of your program.

A Holistic Approach

We offer an innovative approach to biostatistics and data management that considers the entire data lifecycle. These include challenges with study design to meet regulator or investor milestones, to those experienced at site through to data collection, integration, data review and analysis.

We understand that aligning study design to regulator and investor requirements, speed to market and stakeholder decision-making are critical to survival.

Our deep understanding of the data pathway, customized approach, and adaptability to changing environments, yields high quality data and analytics faster.

Our Team

With a presence across Asia Pacific and the US, our highly trained team can support you through all stages of your development program.

Our Study Design & Biostatistics Advisory team supports Sponsors during commercialisation planning — when the foundations of a clinical program are being set. Our focus is simple: to align regulatory strategy with study design, data requirements, analysis planning, and reporting.

Our Data Managers are committed to achieving common project goals through teamwork, collaboration, and open communication. With our solutions-driven approach, our experienced team play a crucial role in successful data outcomes.

PureCDM is a specialist biometrics partner for sponsors, Clinical CROs, and clinical development teams

PureCDM works alongside sponsors, biotech companies, pharmaceutical organisations, medical device companies, CROs, consultants, and research partners that need specialist clinical data and biometric expertise.

We provide flexible support that can be engaged early in planning, during execution, ahead of database lock, during SAP finalisation, or at the point where analysis and reporting confidence are critical.

Whether you need targeted expert input or broader integrated support, PureCDM helps strengthen the connection between study design, data quality, analysis, and decision-making.

“PureCDM were able to build a new and more user-friendly database in short order without disruption to clinical trial activities.

The PureCDM team is by far the best data management group I’ve had the opportunity to work with.”

Verified client – Chief Medical Officer