Clinical trial services

I-ACT for Children

Core Services

• Site Identification & Early Outreach:

  • We extend the c4c Feasibility System to include site evaluations that capture expertise not typically found in routine databases.
  • We identify significant patient groups and provide a comprehensive quality control and summary of available sites.
  • We optimize your clinical trials by minimizing the number of sites, selecting top-tier sites based on specific trial requirements.

Types of Outreach:

  • Small: Early interest in a study and determine the available population (Y/N).
  • Medium: Engage potential sites early on with a survey of up to 10 questions, which we facilitate, prefill, and perform a quality check upon completion.

• Site Facilitation & Engagement:

  • We bridge communication gaps by offering facilitation in local languages, ensuring clarity between sponsors and sites.
  • If you encounter any challenges, from lack of communication to quality concerns, we're here to troubleshoot.
  • We also offer support in facilitating the contracting and budgeting processes, although we don't negotiate specific costs.

Additional Services

• CDA Completion

  • For c4c studies we follow a cascading CDA model; for others we have a CDA-tailered approach according to the sponsors needs.

• Feasibility

  • We assist in completion, quality control, and provide comprehensive summaries.

• Consultancy on National Procedures

  • We offer insights into anticipated timelines, both national and local.
  • Benefit from our protocol review methodology (WP4 ##tabblad)) and support in addressing feedback or comments from local and national regulatory bodies.

• Post-SIV Support

  • If you face recruitment delays or challenges with adverse event reporting, we're here to assist.
  • We also help with communication facilitation, especially if you encounter challenges with site team responsiveness.