Our services

We provide end-to-end CRO and SMO services in specific therapeutic areas, including CNS diseases, cardio-metabolic diseases, 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

We are not your average contract research organisation (CRO). Julius Clinical is a full-service academic CRO that brings academic integrity to every study we run. Our team of scientific leaders and operational experts helps streamline your clinical trial, providing the high-quality data that are required for your study.

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

Real-world evidence (RWE) is essential to determine the benefit/risk balance of treatments in routine clinical practice across populations and geographic regions. We can help you turn Real-World Data into Real-World Evidence.

Learn more

We take study execution to another level.

We use our peer-to-peer model to give our clients access to the best sites and most experienced investigators. Our unique Octopus Concept ensures that our local team functions as a single unit with global operational arms. These systems, combined with our academic rigor, help streamline clinical trials, giving you the best possible clinical trial experience.

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).

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.

Thursday 25 May & Tuesday 30 May

For more options, please get in contact.

 

€ 1045,00   per participant

Including training materials and certificate
Including coffee/tea/lunch

Note: all amounts are excl. tax

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