Expert Clinical Trial Services

BioValeo delivers expert support for every stage of your clinical trial, ensuring quality, compliance, and efficient delivery. From regulatory guidance to data management and monitoring, our services are designed to accelerate your path to market.

Study Country Planning

Our Study Country Planning services ensure your clinical trials are strategically designed and executed. From country-specific assessments to stakeholder engagement and vendor identification, we address regulatory needs, timelines, budgets, and recruitment strategies to set your trial up for success.

  • Comprehensive study planning, including timelines, budgets, and recruitment strategies

  • Country-specific assessments and regulatory requirements identification

  • Stakeholder engagement and vendor qualification

  • Risk, quality, and compliance planning

Clinical Trial Regulatory Submissions

Our Regulatory Submissions services provide expert support to navigate the complexities of clinical trial applications. From acting as a local sponsor representative to preparing regulatory and ethics documentation, submissions, and reporting, we ensure your trial meets all requirements efficiently and accurately.

  • NZ Applicant and Sponsor Representative for study oversight

  • Regulatory and ethics application preparation and submission

  • Documentation preparation and localization

  • Communication and reporting to ensure compliance

Project Management

Our Project Management services provide seamless oversight of your clinical trial from start to finish. We manage study planning, vendors, timelines, budgets, recruitment, and compliance while ensuring quality, mitigating risks, and engaging stakeholders.

  • End-to-end study lifecycle management

  • Vendor, timeline, budget, and recruitment management

  • GCP and regulatory compliance oversight

  • Quality assurance, and risk management

  • Sponsor and stakeholder relationship management

Data Management

Our Data Management services ensure the integrity and accuracy of your clinical trial data. From designing and building eCRF/EDC systems to validation, data cleaning, and analysis support, we provide end-to-end solutions tailored to your trial's unique needs.

  • eCRF/EDC design, build, and validation

  • Comprehensive data management and documentation

  • Data review, cleaning, export, and reporting

  • Support for data analysis and archiving

Monitoring Services

Our Monitoring Services provide comprehensive oversight from start-up to closeout. With experienced monitors and strong site relationships, we ensure effective site management, feasibility assessments, monitoring, and communication to keep your trial on track.

  • Feasibility assessments, site selection, and initiation

  • On-site and remote monitoring with detailed reporting

  • Strong site support, communication, and relationship management

  • Experienced monitors and co-monitoring services