More then 90+ years of experience in our team.
Project management
Our project management ensures seamless study execution through collaboration, clear communication, and strict adherence to timelines, budgets, and regulatory compliance. We provide a single point of contact, manage risks, conduct regular meetings, and oversee vendor and TMF management to support successful trial outcomes.
Project Management at CTC ensures a collaborative and flexible approach that seamlessly meets all study requirements.
Our approach to project management is built on collaboration, proactive communication, and flexibility, ensuring that all study requirements are seamlessly met from start to finish.
- Single Point of Contact: We provide a dedicated contact for the entire study team, streamlining communication and facilitating efficient coordination across all aspects of the study.
- Cross-functional Collaboration: We work closely with all involved functions to ensure smooth study execution. Our approach prioritizes teamwork and open communication among all stakeholders.
- Timelines, Study Plans, Quality, and Budget Management: Our project management team is responsible for overseeing study timelines, ensuring adherence to study plans, maintaining quality standards, and managing the study budget efficiently to meet project goals.
- Risk Mitigation and Issue Escalation: We conduct proactive risk assessments, implement risk mitigation strategies, and escalate issues as necessary to prevent disruptions and maintain study integrity.
- Regulatory Compliance: Our team handles regulatory submissions through the Clinical Trial Information System (CTIS), maintains ongoing communication with local Ethics Committees (EC), and ensures full regulatory compliance throughout the study lifecycle.
- Trial Master File (TMF) Management: We ensure comprehensive and organized TMF management to maintain regulatory compliance and facilitate efficient study audits and inspections.
- Regular Team and Sponsor Meetings: We schedule regular meetings with the study team and sponsors to ensure all members are well-informed, aligned, and able to respond to study developments in real-time.
- Vendor Management: Our vendor management processes ensure that all external partners meet our high standards for quality and reliability, supporting the study’s goals and timelines effectively.
This structured and integrated approach to project management fosters a seamless, efficient process that supports successful clinical trial outcomes while maintaining high standards for quality, regulatory compliance, and risk management.
CTC Netherlands offers highly favorable regulatory timelines, streamlining the path to study initiation. Our fast-track process achieves regulatory approval within 7 weeks of submission, compared to the standard timeline of 15 weeks.
Additionally, recruitment can commence before regulatory approval of the full package. Recruitment documents are submitted as separate filings, enabling an early start to participant recruitment while the main submission is under review. This approach significantly accelerates study timelines, ensuring swift and efficient project execution.
Faster than official regulatory timelines
At CTC Netherlands, we deliver faster lead times, achieving approval in just 49 days, significantly ahead of the 106-day regulatory timeline. With over 50% shorter times, we ensure quicker and more efficient processes to meet your needs.
Experienced Study Team
Discover our
Our research is driven by a highly experienced study team, each member bringing specialized expertise in early-phase clinical trials and patient-centered research. Together, their dedication and knowledge form the foundation for safe, effective, and innovative clinical studies.
With a customer-focused
and flexible approach
With a customer-focused and flexible approach, the PMs coordinate multiple internal deliverables in full-service as well as part-service projects and are ready to solve any challenges that arise during a study.
They skillfully manage vendors and study teams to ensure effective start-up and regulatory compliant conduct of your clinical trial in close collaboration with each customer.
