Our Services Provide Solutions To Your Clinical Trial Needs.

Site Consultancy

Our clinical trial services empower sites with comprehensive support, from feasibility assessments and ethics submissions to regulatory compliance and trial management. We streamline patient recruitment, ensure accurate data collection, and provide expert coordination to optimise efficiency. Partner with us to elevate your site's performance and achieve successful trial outcomes.

    • IRB/IRC and Governance Submissions

    • Query Resolution

    • Completion of HREA

    • Experience in REGIS, ERM, WASM, VSM and eProtocol

    • Budget Negotiation

    • Budget Tracking

    • Contract Drafting and Execution

    • Indemnity Drafting and Execution

    • TGA and FDA Compliance

    • eCTN Application

    • ICH-GCP Compliance

    • Essential Documents Collection

    • Quality Assurance

    • Expertise across all Therapeutic Areas and Phases

    • Excellent Patient Recruitment and Management

    • Data Integrity and Query Resolution

    • Clinical Trials Proposals

    • Sourcing Studies from Sponsors

    • Feasibility, CDA Agreements to Site Selection

    • Project Timeline Plan

    • Clinical Trial Proposals, Feasibility and Site Selection

    • Protocol development

    • Informed Consent Development

    • Network with Pharma and Biotech Companies

Sponsor and Biotech Consultancy

We provide end-to-end clinical trial solutions for sponsors and biotech companies, including site selection, regulatory submissions, patient recruitment, and data management. Our expert team ensures seamless trial execution, compliance with global standards, and high-quality results. Partner with us to accelerate timelines and achieve successful, cost-effective clinical trial outcomes.

    • Patient Centric Design

    • Site Feasibility Assessment

    • Regulatory and Ethical Considerations

    • Site and Investigator Feedback

    • ClinTrials Solution can act as the Australian Sponsor.

    • An Australian Subsidiary can be created to leverage the Australian Research and Development (R&D) Tax Incentive.

    • IRB-IEC Applications

    • Contract and Budget Negotiation

    • Essential Document Collection

    • eCTN Submission

    • Training and Site Readiness

    • Feasibility, Site Selection and Close Outs

    • Protocol Compliance

    • Site Qualification Visits, Site Initiation Visits and Close Out Visits.

    • Data and Source Verification

    • Site Manament and Support

    • IP Accountability

    • ICH-GCP Oversight

    • Extensive Site and PI Network

    • Access to Target Population

    • Identifying Gaps and Challenges with Sites

    • Strategic Planning and Goal Setting

    • Measurable Deliverables

    • Regular Milestone Updates

    • Risk Management

    • Stakeholder Coordination

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