Study Start-Up
- Rapid feasibility assessments and site readiness evaluation
- Transparent budget development and contract negotiation
- Ethics, governance, and regulatory submissions
- SOP alignment and site initiation activities
Integra–CIS Clinical Trials Unit (CTU) is a purpose-built, industry-focused research organisation delivering Phase II and Phase III clinical trials with precision, compliance, and efficiency. We partner with sponsors seeking predictable timelines, transparent operations, and high-quality data—without compromising participant care or ethical standards.
Our model integrates specialist clinical care, robust governance, and operational excellence to support confident trial execution from feasibility through to close-out.
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Participant screening, enrolment, and retention management
Investigational medicinal product (IMP) handling and accountability
Safety monitoring and reporting to sponsors and ethics committees
Timely data entry, query resolution, and ongoing communication
Archiving of essential documents in compliance with regulatory requirements
Final safety, deviation, and compliance reporting
Laboratory sample reconciliation and documentation
Contribution to clinical study reports and publications, where appropriate
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