Sponsor Document · 2026

Capability Statement

A Phase II–IV clinical trials site.

Integra Trials is a specialist clinical trials site in Perth, Western Australia, delivering integrated recruitment, screening and trial execution from a single team, backed by senior clinical leadership and the operational infrastructure of CIS Clinic.

Location

CIS Monash ClinicNedlands, Perth WA

Trial scope

Phase II–IVInterventional & observational

Standards

ICH-GCP · TGA · HRECAligned with NHMRC guidelines

Who we are

An independent clinical trials unit purpose-built for Phase II–IV studies.

Integra Trials Ltd is a Perth-based clinical trials unit, formed through the partnership of senior clinicians and accomplished researchers. Sponsors engage directly with our leadership from first conversation through site close-out.

Why sponsors choose Integra

01

Integrated recruitment-to-delivery model.

Recruitment, screening, enrolment and trial execution run under one specialist team.

02

Senior clinical leadership at the centre.

Our Medical Director, Prof Roger Clarnette, is one of Australia's most experienced clinical trialists.

03

Established clinical infrastructure through CIS Monash Clinic.

A fully equipped, multidisciplinary clinical facility in Nedlands with patient referral networks across WA.

04

Research-grounded operations.

Site operations are built around strict protocol compliance and proactive data quality management.

Site Capabilities & Infrastructure

Everything a sponsor needs to run a study, on one campus.

Integra operates from CIS Monash Clinic in Nedlands, Perth, co-located with the National Imaging Facility. The capabilities below are available to sponsors from day one of study set-up.

01

Experienced clinician & researcher team

Studies delivered under senior principal investigators, supported by research-trained clinical managers and a multidisciplinary clinical workforce.

Senior PIs in place

02

Established CIS clinic with patient traffic

A multidisciplinary medical clinic in Nedlands with regular patient flow, ready referral pathways, and established networks across Western Australia.

Operational from day one

03

GCP-compliant staff

All clinical and research personnel hold current ICH-GCP certification; ongoing training and SOPs reviewed against TGA and NHMRC guidance.

ICH-GCP

04

Blood collection, processing & secure storage

On-site phlebotomy, sample processing facilities, refrigerated and −20°C frozen storage, and chain-of-custody handling for shipping to central laboratories.

−20°C freezer capacity

05

Secure clinical data management

Source data captured and stored to sponsor and regulatory requirements, with access controls, audit trails, and inspection-ready documentation.

Privacy Act 1988

06

On-site ECG equipment

12-lead ECG available on site, operated by trained staff and supported by cardiology oversight through CIS.

Cardiology oversight

07

MRI and PET/CT imaging via NIF

Advanced imaging accessible through the National Imaging Facility node, located adjacent to our clinic, minimising patient burden between visits.

Adjacent — NIF

08

Licensed dispensing pharmacy

Investigational product handling, storage, and dispensing under a licensed pharmacy arrangement, with full accountability records.

IP accountability

09

Contracted pathology — Clinipath

Routine and trial-specific assays via Clinipath, a NATA-accredited Australian pathology provider, with local courier pickup and rapid turnaround.

NATA-accredited

10

In-house biomarker measurement

Research-grade biomarker capability available through Integra's senior research team, appropriate for exploratory endpoints and trial sub-studies.

On request

11

Experienced trialists across patient assessments

Trained in commonly used patient assessment instruments, with consistency across visits and across studies.

Clinical trials experience

12

Practising physician specialist networks

Established referral pathways through networks of practising physician specialists across Perth, supporting recruitment across neurology, cardiology and other therapeutic areas.

Recruitment-ready

Leadership Team

Senior decision-makers, involved end-to-end.

Integra is led by a small team of senior clinicians and accomplished researchers. Sponsors engage directly with this leadership group, not through a sales channel handing off to a delivery team.

The same people who scope a study are accountable for its delivery.

Prof Roger Clarnette

Co-Founder · Medical Director · Geriatrician & Dementia Clinical Trials Specialist

One of Western Australia's most experienced principal investigators in dementia clinical research, with a long career as a practising geriatrician. Leads clinical and scientific oversight across Integra's portfolio.

Dr Philip Currie

Co-Founder & Co-Director · Consultant Cardiologist & CEO, CIS

Practising cardiologist and Chief Executive of CIS – Clinical Integration Solutions Ltd, Integra's clinical partner facility. Provides clinical insight and operational leadership of the partner clinic infrastructure.

Prof John Mamo

Co-Founder & Co-Director · Governance & Strategic Oversight

Accomplished senior researcher and recognised leader in Australian health and medical research. Provides governance, strategic direction and external engagement, helping ensure Integra's growth remains grounded in scientific integrity and the long-term interests of patients, investigators and sponsors.

A/Prof Ryu Takechi

Co-Founder · Clinical Governance & Quality Frameworks

Contributes to Integra's clinical governance and quality framework, supporting systems that promote research excellence, participant safety and regulatory compliance. Background in translational neuroscience and clinical research; provides strategic oversight and scientific guidance across study conduct.

Dr Virginie Lam

Co-Founder · Clinical Research Governance & Compliance

Provides strategic oversight of clinical research governance and compliance at Integra. Background in neuroscience research and clinical trial delivery; supports the systems, processes and quality frameworks that underpin high-quality, participant-centred research.

Extended clinical & research workforce

Through CIS Monash Clinic

Clinicians, registered nurses, allied health professionals, neurocognitive test administrators, pharmacy staff, and research coordinators scale up to the demands of each trial.

Therapeutic Focus & Standards

Where we work, and the standards we work to.

Through our partnership with CIS Monash Clinic, we accept Phase II–IV trials across a range of therapeutic areas.

Therapeutic areas

Neurology & ageing
Cardiovascular disease
Metabolic & endocrine
Respiratory health
Sleep medicine
Liver & hepatology
Stroke
Other indications on enquiry

Indications outside the list above are welcome on enquiry; we assess each one honestly for fit.

Compliance & quality

Integra operates to the regulatory, ethical and operational standards that protect patients, satisfy auditors, and give sponsors confidence in the data we deliver.

ICH-GCP

International Council for Harmonisation, Good Clinical Practice — the global standard.
TGA-aligned

Compliance with Therapeutic Goods Administration requirements for Australian clinical trials.
HREC oversight

Site registered with Bellberry HRECs; each trial requires its own ethics approval before enrolment.
NHMRC guidelines

Aligned with the National Statement on Ethical Conduct in Human Research.
Site insurance

Site-level insurance covering site operations; trial-specific insurance arranged by the sponsor for each study.
Inspection-ready

Source data, regulatory files, and SOPs maintained to support sponsor monitoring.

How to Engage

Starting a conversation is a single phone call away.

Whether you're scoping a single Phase II study or planning a multi-trial programme, the way to start is the same: a short introductory call to understand fit.

01

Initial enquiry

A brief email or call outlining the study, indication, target population, and timeline you're working with.

02

Capability briefing

A 30-minute call with Integra's clinical and operational leadership to discuss fit, feasibility, and any specific sponsor requirements.

03

Formal feasibility

If there's mutual fit, we move to formal protocol feasibility, costing and a draft engagement proposal, typically within 2–3 weeks of the briefing call.

Let's discuss your trial

Timely response to sponsor enquiries.

We'll be honest about whether we're a fit, and if we're not, we'll tell you who is.

Phone

08 6118 5888Direct sponsor line

Email

info@integratrials.com.auInitial sponsor enquiries

Address

CIS Monash ClinicNedlands, Perth WA · Australia

Online

integratrials.com.auFull capability detail & team