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.
Our Clinical Research Services
Biointelect in partnership with the expertise of CR2O, stands at the forefront of clinical trials in Australia and globally. Biointelect delivers expertise in quality clinical trial execution and comprehensive CRO capabilities. Our expert team addresses all of your clinical trial needs and challenges throughout your product development life cycle. We collaborate closely with you to ensure the seamless execution of even the most intricate product development plans and clinical trials, by offering tailor-made solutions that align with your objectives.
Consistent quality delivery of clinical trials by experts
Our team has extensive experience in Phase I to IV clinical trial oversight across a range of therapeutic areas. Standard Operating Procedures ensuring consistent project delivery according to ICH GCP, ISO standards, and local regulations and guidelines. All vendors and subcontractors are qualified suppliers.
Key systems
e-TMF platform to manage clinical trial documentation.
Quality Management System for managing controlled documents.
Salesforce for full financial oversight of the project.
Governance
An experienced project manager will be the central contact person and work closely with the Director, Clinical Affairs.
Every project is reviewed biweekly by senior management.
Our Clinical Research Services Include
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).
Why Biointelect for Clinical Research?
Patient-Centric Trials
Our expertise aligns your clinical trials with your commercial strategy, ensuring your product reaches patients more swiftly.
Extensive Trial Experience
Drawing from significant expertise in Phase I-IV clinical trials, our expert team offers clinical research consulting services across a broad range of therapeutic areas, including vaccines, infectious diseases, oncology, neurology, dermatology and immunology.
Transcending Geographical Boundaries
Clinical feasibility assessment for multiple indications
- The company went on to complete a phase 1 trial in Australia and the product was shown to have an acceptable safety profile.
- Subsequently, the company sought Biointelect’s assistance to help identify and prioritise the best indication for a potential phase Ib/II study. Targets included multiple solid tumours.
- Biointelect conducted a clinical trial feasibility assessment at 10 experienced sites in Australia.
- An interview with a key opinion leader in oncology clinical trials was also conducted to discuss the trial design and logistics.
- Several factors considered together determined that Australian would not be a suitable location for this study; the trial design was complex, the current competitive landscape for oncology clinical trials meant low interest from the sites, and there was a small sample size for the target population.
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.
