Project Management

Julius Clinical has all the staff and systems in place to effectively manage any study, whether it is a small national trial or a large, complex global study.

For each trial, Julius Clinical appoints a project leader, who is the ‘operational partner’ of the in-house scientific leader and is also the partner and key point of contact for the Sponsor. Together, the project leader and the scientific leader appoint a team appropriate for the trial. Each team is set up to provide both original scientific thinking and excellent performance in implementation. In this way, we are able to conduct complex trials while at the same time meeting agreed deadlines and quality standards.

Julius Clinical has a separate department of professionals specialised in planning and tracking clinical projects. The members of this department provide project teams with tools and strategies to optimise performance, and lead Six Sigma initiatives to improve oversight and processes. Tracking progress is vital, especially in the early stages of a trial, so that strategies and processes can be adjusted if necessary without affecting timelines or budgets.

On-site Monitoring, Remote, Central and Medical Monitoring

For international monitoring, the US Food and Drug Administration (FDA)’s risk-based guidance is being followed. These guidelines result in a focus on critical study parameters and the use of a combination of monitoring activities to oversee a study appropriately. Site management and monitoring tasks in countries outside the Netherlands are performed by local partners but managed centrally by Julius Clinical.

Monitoring by Julius Clinical is typically a mix of on-site, off-site and central monitoring. Central monitoring usually involves continuous statistical analysis of locally collected data to identify data trends, performance metrics, and statistical patterns across all sites.

Implementing (risk-based) monitoring is based upon the risk-profile of individual sites.

Julius Clinical will facilitate the following:

  • site selection;
  • training of staff;
  • dedicated quality control;
  • compliance;
  • monitoring visits;
  • tracking of study milestones (via a unique Clinical Trial Management System).

Overall, this means that the number of on-site visits can be allocated more efficiently without compromising on quality in any way. Our services can be tailored to your specific needs.

We also perform site management and monitoring for investigator initiated trials. Within the Netherlands, we follow the guidelines of the NFU (Dutch Federation of Universities). We apply risk-based monitoring tailored specifically to our clients’ needs.

Data Management

We offer data management services based on full electronic data capture (EDC) for clinical research projects. These services are provided in collaboration with partners at the Julius Center for Health Sciences and Primary Care (Utrecht, The Netherlands). 

Experienced clinical data project managers coordinate key activities and manage study data flow, ensuring that data are collected, handled and stored accurately and appropriately. In addition to regular data management tasks, efforts are made to add value to clinical research projects by leveraging the available information for project management and compliance, in order to facilitate the use of central and risk-based monitoring approaches.

Our data management department and partners operate in full compliance with all applicable regulations, including GCP and FDA 21 CFR, part 11.

We use EDC-agCapture™ database to manage and store data. This is an innovative EDC system that fully unifies EDC, randomisation & trial supply management and ePRO with medical dictionary coding, CTMS and internal patient compliance modules. This database can be designed to allow swift protocol changes and amendments into the database to reduce costs and time of validating the patient data.

Medical Safety & Pharmacovigilance

Our safety and pharmacovigilance team comprises experienced and highly trained safety physicians and officers, who are active members of specialist groups within several national associations of pharmaceutical medicine.

The team members can be available 24/7 to ensure timely and appropriate follow-up and assessment, and have been involved in the assessment and processing of individual case safety reports for more than 90,000 subjects in 24 countries. The team offers preparation, distribution, and processing of cases for review and adjudication. A designated pharmacovigilance application enables optimal tracking of the information flow of each individual case. This software tool ensures adherence to the timeframes for initiation, follow-up, review and reporting of adverse events and reactions.

As an additional service, Julius Clinical can provide assistance with preparing for, conducting, and reporting pharmacovigilance audits. Advanced safety training can also be provided.

(e)Document Storage

We use agClinical™ database to manage and store data. This is an innovative CTMS system that includes eDocument storage capabilities for tracking of regulatory and study documents.

Clinical Study Report

The academic leaders affiliated with Julius Clinical and with the Julius Center for Health Sciences and Primary Care have published more than 3,000 articles in peer-reviewed journals in the past decade. The aim is to quickly and effectively communicate results in leading scientific journals in order to potentially improve patient care. We believe that the publication of trial results and the dissemination of the results at conferences are key components in the advancement of medical scientific knowledge. We welcome the opportunity to be part of the publication strategy.

Study reports can be finalised very quickly, to tight deadlines. This is made easier by the fact that the studies are typically designed with the study report in mind, so that the collection and integrity of the required data can be monitored closely during the trial.

Quality Assurance and Compliance

We have a team of quality assurance managers whose role is to ensure trials are conducted to the highest standards, particularly with respect to patient safety and data integrity.

Regular audits are performed, both within Julius Clinical and at the centres worldwide, where trials are being performed.

The quality assurance team is always consulted during the design phase of projects. They will advise the clinical operations department on the regulatory aspects of trials, and ensure that the processes developed meet the criteria established in the guidance on Good Clinical Practice.

Training

We recognise that effective preparation and ongoing training of sites is crucial to minimise the level of monitoring required and to prevent protocol violations and unnecessary additional queries. In order to harmonise study procedures and processes, we assign a dedicated project compliance manager to each study. This manager develops a reference guide tailored to the specific trial’s requirements, highlighting procedures, processes, and available tools.

We can also provide training as a separate service, and we have much experience running training sessions on standard operating procedures, good clinical practice, and field operations.