We ensure high quality execution of global trials

Through pragmatic trial design, creative patient recruitment strategies, high investigator centricity and tailored data monitoring strategies, we develop the most cost effective studies with a guaranteed high standard of data output.  

We achieve this by bringing together academic knowledge, operational excellence, process development and embracing the innovation required to develop new insights in medical care.

Thus, we help you to get your treatments to patients faster by combining the latest scientific insights with operational excellence. 

Scientific Services

Scientific Leadership

Julius Clinical has internationally recognised academic leaders on our staff, who are actively involved in the design, implementation, and interpretation of clinical trials. This scientific expertise and credibility, combined with personal links with peers around the world, means that the company has a truly global reach and reputation.

Our scientific leaders have broad experience on steering committees and are able to bring together, and work effectively with, international networks of thought leaders. This strength permits an extensive range of services which can be tailored to meet the needs of our partners.

Study Design

Julius Clinical’s scientific team members have an extensive track record in the design of phase IIB-IV clinical trials. Recommendations on study design are typically based on a thorough analysis of the drug itself, the main hypothesis being investigated, the intended healthcare setting, and the initial plans for executing the trial.

These recommendations have frequently led to significant reductions in timelines and costs in the development of new drugs.

Protocol Development

We offer cutting-edge protocol advice. Through our world-class academic network, we have access to experts with an excellent understanding of the requirements expected by regulators, which helps build the protocol design that will deliver the outcomes needed. Furthermore, smart design of clinical trials is our specialty. It can tremendously reduce the overall costs of studies as well as strengthen the credibility of clinical outcomes. It starts by questioning whether a trial can be better performed, more efficiently and faster, while never losing sight of the reliability and high quality of our work. In order to increase the credibility of clinical outcomes, we add extra checks and balances: firstly, by giving more responsibility to independent academic researchers; secondly and more importantly, by maintaining the freedom to ultimately publish clinical trial results without restrictions – even if the findings may not favor the new treatment.

Feasibility

Julius Clinical can quickly perform feasibility studies in a wide range of settings and therapeutic areas, making use of our international network of thought leaders and investigators. This network sets us apart from other CROs and is based in our Academic roots. Through these networks, and peer-to-peer discussions, the scientific team can inspire and motivate investigators to take part.

Feasibility studies may include assessment of:

  • Investigator interest;
  • Recruitment potential;
  • Recruitment and retention rates;
  • Site personnel study experience and training;
  • Trial-required facilities, such as laboratories and pharmacies;
  • Quality assurance processes.

Biostatistics

Julius Clinical executes its biostatistics services through its in-house statisticians and in close collaboration with the academic Department of Biostatistics at the Julius Center for Health Sciences and Primary Care  in Utrecht, The Netherlands. Under the leadership of Professor Rene Eijkemans, the department combines strong clinical research experience with the full benefits of an academic research setting, allowing expert input into clinical research design and statistical analysis plans.

Typically the top-line results and the findings of secondary analyses will be reported in the resulting scientific publications as well as in the clinical study report. Depending on sponsor requirements, analyses and reports that are fully ICH (International Conference on Harmonisation) compliant can be provided.

Julius Clinical can also help provide independent statistical analyses for pivotal or high profile clinical trials, and act as the statistical coordinating centre for interim analyses. Successful examples include the CONTRAST, EUFEST, and ADVANCE studies.

Endpoint Management and Adjudication

Regulatory authorities are increasingly interested in holding sponsors accountable for the demonstration of proper safety management, and the classification of simple and composite morbidity and mortality endpoints as either primary or secondary endpoints. To help clients meet the growing demands for verified endpoint data, Julius Clinical can manage the full adjudication process.

This can include the development of standard and clinically reasonable definitions, charter development, timely endpoint package field management, and sophisticated status report and impact analysis.

Project Implementation

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 and complex, global pivotal 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 with the sponsor. Together, the project leader (who typically has experience working for a pharmaceutical company or clinical research organisation) 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, Julius Clinical is 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. The underlying principle is that improvements can always be made.

Site Selection

The partners selected for any one trial will typically be those that are known to be most capable of performing the required tasks, based on experience to date. The assessment, selection, training, contracting, management, and compliance of local partners in every country are closely managed.

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. It should be anticipated that there will be differences in timelines for site activation.

Building on our existing MSA, Julius Clinical is able to quickly proceed a work order for the concerned study and initiate the start-up processes.

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

  • Timely communication and active collaboration with client to finalize 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 Julius Clinical’s contracts group. 

Site Management

Julius Clinical has broad experience managing and monitoring sites for national and large international studies. We have been involved in at least 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, Julius Clinical is 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. 

On-site Monitoring, Remote, Central and Medical Monitoring

For international monitoring, the US Food and Drug Administration's (FDA) risk-based guidance is being followed. Both 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.

Julius Clinical also performs 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

Julius Clinical offers 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.

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

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

Medical Safety & Pharmacovigilance

Julius Clinical´s 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

Julius Clinical uses 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 a key component 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.

Project Support

Quality Assurance and Compliance

Julius Clinical has 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

Julius Clinical recognises 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, Julius Clinical assigns 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.

Julius Clinical also provides training as a separate service, and has much experience running training sessions on standard operating procedures, good clinical practice, and field operations.