Our services

We provide end-to-end CRO and SMO services in specific therapeutic areas, including: Neurological diseases, cardio-metabolic, renal, and infectious diseases & vaccines.

Our expertise covers all aspects of clinical trial management — from early phase to post-registration. If your project requires real-world data, we have the experience needed to provide that too. Our nimbleness and ability to provide innovative, science-based solutions are how we make a difference for our Sponsors.

Our CRO Services

At Julius Clinical, we go beyond the typical contract research organization (CRO) model. As a full-service therapeutically specialized CRO, we uphold scientific integrity in every study we undertake. With a team comprising scientific leaders and operational experts, we are equipped to not only streamline your entire clinical trial but also offer individualized services tailored to your specific needs. Whether you require comprehensive support or specific components of a study, we provide the expertise and flexibility to deliver high-quality data essential for the success of your research.

Design

  • Study design and methodology
  • Protocol development
  • Statistical Analysis and Programming
  • Scientific consultation
  • Feasibility research

Start-up

  • Regulatory submissions
  • Site qualification and selection
  • Site contracting and payments
  • Training research sites and staff

Conduct

  • Patient recruitment and retention
  • Central Risk Based Monitoring and SDV (on-site & remote)
  • Medical monitoring and Safety
  • Pharmacovigilance
  • Data management and Biostatisics
  • Quality assurance and compliance
  • Vendor management
  • Project management

Reporting

  • Study Analysis and reporting
  • Endpoint management and adjudication
  • Medical writing
  • Data Monitoring Committee (blinded /unblinded)

Diverse Trials and Real world evidence

  • Remote decentralized & hybrid trials
  • Registries & observational studies
  • Pragmatic trials
  • Wearables and Devices

Technology & systems

  • eTMF & CTMS
  • EDC
  • Interactive web/voice response system
  • Power BI, MS project

Our SMO Services

As Site Management Organisation, Julius Clinical provides out of the box solutions for Site Operations. We specialize in large scale recruitment (20K+ participants) and function as Coordinating Centre for multiple (Satellite) Sites.

Participant access

  • Primary Care Research Network & other scientific networks
  • Direct recruitment via (social) media
  • Patient networks

Centralised operations

  • Recruitment
  • Pre-screening
  • Logistics & Planning
  • Call Centre for participants
  • Telehealth staff

Decentralised operations

  • E-solutions (ePRO, telehealth, etc)
  • At-home assessments (self-sampling, home visits)
  • Pop-up (Satellite) Site locations

Site support

  • Staffing (Sub-investigators, Research Nurses, Site Coordinators, Site Administrators)
  • Training
  • (Local) submissions

Real World Evidence

At Julius Clinical, we specialize in harnessing the power of Real World Evidence (RWE) to drive impactful research and deliver meaningful insights. With our experience in designing and executing RWE studies, we support our clients in understanding the effectiveness, safety, and value of healthcare interventions in real-world settings.

Our dedicated team of experts leverages a comprehensive approach to RWE, integrating data from diverse sources such as electronic health records, claims data, patient registries, and observational studies. By doing so, we provide robust evidence that complements traditional clinical trials and informs decision-making for healthcare stakeholders.

Click on the video to learn more about our Real World Evidende approach.

Read more about our Real World Evidence

We take study execution to another level.

We utilize a peer-to-peer model to grant our clients access to top-tier sites and highly experienced investigators. This approach ensures seamless collaboration within our local teams while maintaining global operational effectiveness. Combined with our scientific rigor, these systems work to streamline clinical trials, providing you with an unparalleled clinical trial experience.

Click on the video to learn more about our peer-to-peer model.

Location

Julius Clinical, Zeist

Duration

2.5 day training

Monitor Training

Are you interested in working as a Clinical Research Associate and want to know what monitoring is all about? Or have you been asked to monitor clinical research in your hospital? Then the Monitor Training is suitable for you.

The duration of the course is 2 days with an additional 0,5 day session to reflect on lessons learned of the training versus the practical experience.

Within the course, theory will alternate with interactive exercises and discussions to ensure implementation  of the learning in daily practice.

Preparation activities prior to the first 2 days of face to face training (e.g. reading of training materials) involve 1 hour of homework for each training day, thus 2 hours in total.

The following topics will be discussed:

  • Update GCP
  • WMO vs GCP
  • Monitoring:
    • General
    • Tasks & Responsibilities
    • Visits: site selection, initiation, monitoring & close-out
  • Sponsor
  • Monitor (Investigator and Sponsor Initiated Trials)
  • Monitor plan and visit preparations
  • Investigator Site File
  • Clinical Trial Protocol
  • IRB/IEC
  • Informed Consent procedure
  • Source Data Verification
  • Practice of a monitoring visit (including preparation, conduct and follow-up)

At the end of the course, the participant will be able to:

  • Describe the tasks and responsibilities regarding the function of a monitor
  • Describe and conduct the procedures, law and regulations regarding monitoring
  • Perform a monitoring visit
  • Recognize and name individual qualities and points of attention regarding monitoring related competences

Staff involved in management or conduct of monitoring (e.g. study coordinators, research nurses). This training will be given in Dutch.

The course will be lead by an experienced trainer with significant and relevant experience in the field of clinical research.

There will be a minimum of 5 and a maximum of 15 participants for this training to ensure a maximum learning effect.

  • Day I: Thursday 07 Nov 2024 (9:00-16:30)
  • Day II: Tuesday 12 Nov 2024 (9:00-16:30)

€ 1045,00   per participant

Including training materials and certificate
Including coffee/tea/lunch

Note: all amounts are excl. tax

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