Clinical trial start-up is one of the most critical phases in the clinical research lifecycle. Delays or inefficiencies at this stage can significantly impact timelines, budgets, and overall study success. From protocol finalization and site selection to regulatory approvals and contract negotiations, sponsors and research teams face multiple operational, regulatory, and logistical hurdles.

This webinar will provide a practical and experience-driven overview of the most common challenges encountered during clinical trial start-up and offer actionable strategies to overcome them. Designed for professionals involved in clinical research, this session will bridge the gap between regulatory expectations and real-world execution, helping organizations accelerate study initiation without compromising compliance or quality.

Key Challenges Covered in the Webinar

• Protocol Complexity and Amendments
  Poorly designed or overly complex protocols often lead to feasibility issues, amendments, and delayed site activation.
• Site Selection and Feasibility Delays
  Identifying the right sites with adequate patient populations, infrastructure, and experience remains a major bottleneck.
• Regulatory and Ethics Approvals
  Variability in regulatory requirements, ethics committee expectations, and submission quality can slow down approvals.
• Contract and Budget Negotiations
  Prolonged negotiations between sponsors, CROs, and sites often delay site initiation visits (SIVs).
• Document Readiness and Compliance Gaps
  Missing or inconsistent essential documents can halt start-up progress and trigger regulatory findings later.
• Cross-functional Coordination
  Lack of alignment between clinical operations, regulatory affairs, legal, and finance teams can create unnecessary delays.

What You Will Learn

• Practical strategies to streamline clinical trial start-up timelines
• How to proactively identify and mitigate start-up risks
• Best practices for regulatory submissions and ethics approvals
• Approaches to improve site engagement and readiness
• Tips for efficient contract and budget negotiations
• How early planning can reduce downstream trial delays and costs

Why Should You Attend?

• Reduce Start-up Delays: Learn proven methods to accelerate study initiation.
• Improve Compliance: Understand regulatory expectations and documentation best practices.
• Gain Practical Insights: Benefit from real-world examples and industry lessons learned.
• Enhance Collaboration: Discover ways to improve coordination across internal and external teams.
• Optimize Resources: Avoid costly amendments, rework, and missed timelines.

Who Will Benefit from This Webinar?

• Clinical Operations Professionals
• Clinical Research Associates (CRAs)
• Regulatory Affairs and Start-up Specialists
• Clinical Project Managers
• CRO and Sponsor Teams
• Investigators and Site Management Professionals
• QA and Compliance Personnel
• Early-career professionals entering clinical research

Join this webinar to gain clarity, confidence, and control over clinical trial start-up challenges—and ensure your studies begin on time, within budget, and fully compliant with regulatory expectations.