Project Implementation

Site Selection

The partners selected for any trial will typically be those that are known to us as being the most capable of performing the required tasks. Our scientific network partners also support us in the selection of sites. The assessment, selection, training, contracting, management, and compliance of local partners in every country are closely managed by Julius Clinical.

Site Start Up

By leveraging our experience from similar studies, we are able to ensure favorable site activation timelines and avoid delays in the setup of screening facilities. For multi-center trials, the expected differences in regulatory timelines between the proposed countries should be considered.

Julius Clinical’s rapid startup strategy focuses on these key factors:

  • Timely communication and active collaboration with client to finalise and communicate site selection decisions.
  • Study startup packs immediately sent to qualified sites.
  • Upfront analysis of regulatory requirements per country, including critical documents and radiation boards requirements.
  • Selection of a central Ethics Committees (IEC) with a proven track record of speed and efficiency based on previous experience.
  • Clear mapping of site-level contract processes as well as IEC submission requirements and deadlines.
  • Proactive assistance to sites with responses to any IEC issues and support of a timely contracts approval process by using our own contracts group. 

Site Management

We have broad experience managing and monitoring sites for national and international studies. We have been involved in more than 47 studies for which we have provided monitoring services, varying in size from 10 to 900 study subjects. We centrally coordinate and manage site activities through direct communication with investigators. Tools and systems are provided that ease the administrative workload and help keep investigators inspired and motivated throughout the study.

Patient Recruitment & Retention

With the introduction of the peer-to-peer model, we are able to positively influence patient recruitment, patient retention, and other vital aspects of the study. Because of our collaboration with  local leaders and investigators in our network, short communication lines are held to:

  • Inform and educate the site study teams on the disease and study design;
  • Promote best practices and share experiences;
  • Answer questions and act as a moderator for the Sponsor.