Clinical Research Services
Clinical Affairs Services
At Biointelect, we deliver independent clinical leadership that combines development strategy, governance, and oversight to maintain control of trial delivery. Acting as an extension of your clinical team, we ensure CRO and vendor performance is aligned, risks are actively managed, and decisions are made with confidence.
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.
Sponsor Support
Clinical Development Strategy
- Trial design aligned to development objectives
- Protocol and Investigator Brochure input
- Endpoint and cohort strategy support
- Early-phase decision guidance
Shape the study not just monitor it
Sponsor Representation
- Local sponsor representative (Australia)
- Interface with CROs, sites, and KOLs
- Support feasibility and site engagement
- Bridge global Sponsor ↔ local teams
Your clinical team on the ground
Regulatory & Ethics Interface
- Support HREC and TGA submissions
- Ensure alignment with local requirements
- Guide global regulatory positioning
- De-risk cross-border trial execution
De-risk international trials
Safety & Study Governance
- Oversight of SRC/DSMB structures
- Medical and safety decision input
- CRO safety reporting alignment
- Escalation pathways and review
Independent clinical and safety oversight
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).
CRO Oversight
Biointelect sits on the Sponsor side of the table, keeping your CRO and vendors aligned, accountable, and delivering to plan.
Drive Control Without Running the CRO
Sponsor-side leadership
- Single point of contact across CRO(s), sites, and vendors
- Embedded in all Sponsor and CRO governance forums
- Clear escalation to senior clinical leadership when it matters
Keep the trial on track
- Proactive issue resolution and bottleneck removal
- Live oversight of timelines, decisions, and delivery risk
- Structured reporting cadence aligned to Sponsor needs
Assure Quality & Compliance (Independently)
Real oversight, not passive review
- Active management of risk registers and decision logs
- Review of key trial plans and CRO outputs against local regulatory expectations
Vendor performance you can see
- KPI-driven oversight across safety, data, and quality
- Independent audit capability for critical vendors
- CAPA framework to resolve issues and prevent recurrence
Always inspection-ready
- TMF review, SOP oversight, and ongoing quality monitoring
- Structured compliance reporting with trends and actions
Discover how our bespoke CRO services can support you.
What the Sponsor Gains
Clarity
One view of trial status, risks, and decisions
Control
Proactive governance without adding internal headcount
Confidence
Independent oversight of CRO and vendor delivery
Speed
Faster issue resolution & decision-making
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.
