Clinical Research Services
At Biointelect, we are passionate about advancing novel technologies that can transform patient care. As a trusted partner across the full life sciences ecosystem from research to commercialisation, Biointelect is consistently at the forefront of innovative healthcare trends and the clinical trials landscape.
Clinical Research Services
At Biointelect, we are passionate about advancing novel technologies that can transform patient care. As a trusted partner across the full life sciences ecosystem from research to commercialisation, Biointelect is consistently at the forefront of innovative healthcare trends and the clinical trials landscape. 
Clinical Research Services
Clinical Research Services
At Biointelect, our mission is to redefine the CRO experience by providing a bespoke delivery model that adapts to your study’s needs and ensure that you receive the focused and specialised attention that every client deserves.
Single, dedicated, point of contact to oversee all aspects of the trial
Collaboration, accountability, and continuity are the key.
We ensure streamlined communication and fast, informed decision-making.
Strong collaborative relationships with leading Key Opinion Leaders and research sites
We anticipate and respond to unique operational needs, driving recruitment and reliable execution.
We uphold high standards of quality and compliance.
Small by design with a highly specialised team united by years of working together
We have deep early-phase expertise and a proven track record of delivery across complex trials.
We are agile and adaptable offering true cross functional collaboration.
Our Operational Capabilities
From single service to full-service solutions
Biointelect delivers operational capabilities that adapt to your needs. Whether you require a single specialised service or a complete, end-to-end clinical solution, our tailored approach ensures efficiency, quality, and seamless collaboration at every stage.
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).
Get in Touch
Wherever you are in your new product journey, Biointelect’s unique expertise across each stage of the life science value chain means we are ready to bring your innovative life science to market.
Take the next steps in advancing healthcare for all by contacting our team of local Australian and global life science experts today.
