What PureCDM does

PureCDM Pty Ltd is an Australian specialist biometrics consultancy founded in 2010 and headquartered in Parkdale, Australia. The company provides integrated clinical data and biometric services to biotech, medical device, pharmaceutical, and CRO clients, supporting sponsors across the clinical trial lifecycle from study planning through regulatory reporting. PureCDM operates as a privately held, self-funded boutique firm with 1-10 employees and no disclosed institutional investors.

The firm's core offering comprises four interconnected service lines: Advisory (study design, protocol development, estimands, endpoints, statistical considerations), Clinical Data Management (data quality, eCRF review, query management, database lock preparation, vendor/CRO oversight), Biostatistics (sample size development, SAP planning, analysis outputs, top line reporting, interpretation), and Pharmacokinetics (sampling strategy, analysis planning, concentration-time data interpretation). Underlying technology capability centers on multi-platform Electronic Data Capture (EDC) expertise — PureCDM builds across multiple EDC platforms with a software-neutral, tailor-made approach, supported by a documented quality management framework and risk mitigation methodology.

PureCDM's business model is professional services revenue earned through direct, consultative enterprise sales. Engagement options include project-based work, retainers, and flexible support arrangements in which PureCDM operates as an extension of the client's project team. Pricing is tailored and quote-based, with no publicly disclosed rates. The company's geographic footprint spans Asia Pacific and the United States, and it complies with the Australian Privacy Principles under the Privacy Act 1988 (Cth). PureCDM has 15 years of brand recognition supported by a management team with 25+ years of clinical development experience across therapeutic areas and Phase I-III trials.

Name

PureCDM

Legal name

PureCDM Pty Ltd

Website

https://purecdm.com.au

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

1–10 employees

Short description

PureCDM is an Australian boutique biometrics consultancy offering integrated advisory, clinical data management, biostatistics, and pharmacokinetics services to biotech, medtech, pharmaceutical, and CRO clients across Asia Pacific and the United States.

Ownership category

akta.pro rank

Product category

Clinical Data Management Services

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Misc Health & Allied Services, Nec (8090)

akta.pro primary industry

Clinical Data Management (CDM), Data Cleaning & Reconciliation (HLACAOAG)

akta.pro secondary industries

Clinical Trial Analytics, Risk-Based Monitoring (RBM) & Quality Management (HLACAOAI), Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)

Keywords

• Clinical data management
• Biometrics consulting
• Biostatistics services
• Pharmacokinetics consulting
• Clinical trial advisory

Headquarters

HQ city

Parkdale

HQ country

Australia

HQ region

Oceania

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales

Revenue model

1. Biometrics Consulting Services: Professional services revenue from advisory, clinical data management, biostatistics, and pharmacokinetics consulting. Services are offered as project-based engagements, retainers, or flexible support arrangements where PureCDM works as an extension of the client's project team.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

PureCDM is a specialist biometrics consultancy providing integrated clinical data management, biostatistics, pharmacokinetics, and advisory services to biotech, pharmaceutical, medical device, and CRO clients. Services are delivered by senior experts as an extension of client project teams across the clinical trial lifecycle, from early study design and protocol development through database lock, SAP finalization, analysis, and regulatory reporting.

Product overview

PureCDM is a specialist biometrics partner offering integrated clinical data and biometric services to biotech and medtech companies. The company provides four interconnected service offerings: Advisory (strategic input on study design and protocol development), Clinical Data Management (data quality protection and database lock preparation), Biostatistics (statistical analysis and reporting), and Pharmacokinetics (PK strategy and data interpretation). These services are designed to work collaboratively across the clinical trial lifecycle, from early study design through final regulatory reporting.

Differentiator

Problem solved

Functional benefit

Quantifiable outcome

• Reduced avoidable delays through early risk identification
• +2 more outcomes

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators3 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• MMS Holdings: Data-focused CRO providing clinical data management, biostatistics, and pharmacovigilance services to biopharma — overlaps almost entirely with PureCDM's service lines for biotech and specialty pharma sponsors.
• Clinipace Worldwide: Mid-sized CRO providing clinical data management, biostatistics, and regulatory services to emerging biopharma — competes for the same type of small-to-mid biotech sponsor engagements.
• Rho: Full-service CRO with a strong biometrics and data sciences practice supporting small and mid-sized biopharma — comparable client mix and CDM/biostatistics offering to PureCDM.
• Veramed: Statistical and clinical data management consultancy offering biostatistics and CDM services to pharma and biotech — directly competitive with PureCDM on the biometrics consulting dimension.
• Cytel: Specialty biostatistics and statistical software consultancy serving clinical drug development with deep statistical and adaptive trial expertise — directly comparable to PureCDM's biometrics focus.

Emerging players

• CluePoints: Risk-based monitoring and centralized analytics vendor for clinical trials — adjacent rather than direct, but increasingly overlaps with CDM/quality workflows PureCDM supports.
• Pro-ficiency: Clinical trial simulation and protocol optimization technology vendor — adjacent to PureCDM's advisory service line around study design and protocol risk mitigation.

Broad incumbents

• Parexel International: Global full-service CRO with extensive clinical data management and biostatistics groups — represents the incumbent competitor ecosystem for boutique biometrics consultancies.
• IQVIA: Largest global CRO with full biometrics capabilities; competes with PureCDM on complex study data management, though its scale and breadth differ substantially.
• Worldwide Clinical Trials: Global mid-sized CRO with biometrics and data management services across all phases — broader portfolio but relevant competitor for PureCDM's biotech and medical device clients.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights5 records

Customer concentration

• LinkedInlinkedin.com/company/purecdm

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about PureCDM