Julius Clinical has access to internationally recognised key opinion leaders in various therapeutic areas who we can call on to be actively involved in the design, implementation, and interpretation of clinical trials. This scientific expertise and credibility, combined with personal connections with peers around the world, means that we have a truly global reach. 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 gives us an extensive range of services which can be tailored to meet the needs of our Sponsors.
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, allowing our Sponsors to get new medication to the market faster.
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: first, by giving more responsibility to independent academic researchers; second 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.
Julius Clinical can quickly perform feasibility studies in a wide range of settings and therapeutic areas, making use of our international networks of thought leaders and investigators. These networks set 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.
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. 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.
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, we 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.