Clinical Research Organisation (CRO)
Clinical trials designed for speed, quality and global impact
Biointelect is a full‑service Australian CRO specialising in early‑phase and complex clinical trials. We partner with biotech and pharmaceutical companies globally to design and deliver studies that generate high‑quality data and support downstream regulatory and commercial success.
Our model is deliberately different: clinical trial execution is integrated with in‑house regulatory and governance expertise, ensuring trials are built to stand up to global expectations from day one.
Why Run Your Clinical Trial in Australia?
SPEED
- Faster start‑up through a streamlined Clinical Trial Notification (CTN) scheme, with ethics committees leading trial review.
- No FDA IND required to commence trials, enabling earlier program progression.
QUALITY
- Globally accepted data suitable for US FDA, EMA and other international regulatory submissions.
- A world‑class early‑phase ecosystem, with experienced investigators, accredited institutions and strong patient participation.
VALUE
- Cost‑effective generation of robust human data that supports better development decisions, de‑risks investment, and strengthens partnering discussions.
- Cost advantages through Australia’s R&D Tax Incentive, reducing the net cost of eligible clinical activities.
A Full-Service CRO with Regulatory Built In
Biointelect delivers end‑to‑end CRO services, tailored to your study and development stage. We act as a primary CRO or provide senior local oversight alongside a global partner.
What sets us apart is how we deliver.
Our regulatory experts work side‑by‑side with the CRO team, embedding regulatory thinking into protocol design, operational decisions and trial documentation. This reduces downstream risk, avoids rework, and ensures trials are aligned with global regulatory pathways, not just local execution.
Study Management
- Project Management and oversight.
- Ethics and regulatory submissions.
- Vendor management (IP, central laboratories).
- Trial Master File setup, maintenance, quality assurance and close-out.
- Site and Sponsor communications.
- Regular operations meetings/ teleconferences with sponsor.
- Risk Management.
Clinical Monitoring
- Plan development (Monitoring Plan).
- Initiation, monitoring (onsite and remote), Close-out.
- Site communication.
- Protocol deviation surveillance and reporting.
Design and Review of Oversight Plans
- DSMB/SRC charter.
- Design of plans including; Project Management (including communication and risk) Monitoring, Safety Management, Data Management, and Statistical Analysis Plan.
Medical and Safety Monitoring and Pharmacovigilance
- 24/7 local oversight medical monitoring, DSMB management including report preparation and meeting(s), review and approve medical narratives.
- Register the therapy in the appropriate databases and prepare/submit SUSAR submission to TGA.
- Draft interim and annual safety report (if/as required).
Data Management, Biostatistics, and Medical Writing
- Electronic data capture (eDC) – develop eCRF and completion guidelines, train the site, data monitoring and coding, perform EDC computer system validation.
- Draft statistical analysis plan, perform interim and final statistical analysis, provide TLF and final statistical report.
- Preparation of Clinical Study Report.
Investigator Site Oversight
- Ethics and Site-Specific Application.
- Participant recruitment, clinical and medical oversight of participants.
- Conduct of clinical trial procedures per protocol, collection, and processing of biological samples.
- Pharmacy services.
- Data entry into eDC, maintenance of investigator site file.
- Local laboratory testing
(if required).
More Than a CRO Partner
For international sponsors, Biointelect can also support Australian market entry through governance, Resident Director services and R&D Tax Incentive coordination creating a seamless bridge between clinical delivery and corporate requirements.
Ready to start your trial in Australia?
Whether you’re planning your first clinical study or expanding a global program, Biointelect offers a CRO partnership built on execution discipline, regulatory insight and long‑term value.
CR2O provide leadership and operational excellence in conducting Phase I-IV clinical trials and their global network of experts.
5 Horizons is a US‑based VCaaS firm that combines structured capital with CRO execution partners to help biotechs overcome early‑stage funding and delivery barriers to reach clinical validation.
QNova Life Sciences provide direct FDA support through their US-based consultancy.
Frequently Asked Questions
What key Australian & global regulators do you help companies navigate?
We harmonize local Australian requirements with international standards. We provide expert guidance for TGA (Australia) submissions and act as your Legal Local Sponsor. Additionally, we align Australian clinical data with FDA (USA) and EMA (Europe) global strategies for parallel regulatory engagement.
Why do sponsors choose Biointelect
Biointelect has deep experience across oncology, infectious diseases, vaccines, neuroscience, cardiovascular and metabolic disease, medical devices, and cell and gene therapies.
We are trusted with:
- First‑in‑human and Phase I–II studies
- High‑risk or inpatient trials
- Accelerated and adaptive development programs
- Sponsors seeking strong local governance without duplication
Small by design, we offer senior continuity, clear accountability and direct access to experienced decision‑makers throughout the life of your study.
What role does a Contract Research Organisation (CRO) play?
A CRO provides outsourced research services to the pharmaceutical, biotechnology, and medical device industries. Biointelect serves as a strategic partner, offering bespoke clinical trial management, local legal sponsorship, and regulatory oversight to ensure trials are executed with speed, quality, and global compliance.
How does Biointelect integrate regulatory strategy into clinical trial delivery?
Biointelect’s regulatory experts work directly alongside the CRO team from early study design through trial execution. Regulatory considerations are built into protocols, operational decisions and documentation, reducing downstream risk and ensuring trials are aligned with global regulatory pathways—not just local requirements.
How quickly can a trial start in Australia?
Australia offers one of the fastest trial start‑up environments globally through a streamlined ethics‑led approval process. With no FDA IND required to commence, well‑planned studies can progress rapidly once ethics and site approvals are in place.
