Analysis, Publication and Presentation of results
ITREAS can develop a publication strategy for you to ensure that your results reach the target audience with maximum impact, therewith contributing to patient care. Once your database in locked, ITREAS and the scientific leadership will analyse the results together with your representatives and will ensure that the primary and secondary findings are disseminated to […]
Safety Board
Safety Board services Independent monitoring of your clinical trial to ensure patients’ safety is critical. The Safety Board or DMC (Data Monitoring Committee) reviews safety and key efficacy data to ensure patients’ safety during their participation in your clinical trial and is charged with making recommendations based on interim analyses and in line with stopping […]
Medical Monitoring & 24/7 Investigator Support
Medical Monitoring ITREAS provides medical monitoring services to (co-)monitor compliance by the sites with pre-defined protocol procedures and requirements. We assist with (the design of processes) for the review of (blinded) patient and site data such as (S)AEs, study medication administration and compliance, concomitant medication and laboratory results to safeguard the patients’ safety throughout the […]
Endpoint Adjudication & Coordination
Independent blinded adjudication services ITREAS has extensive experience in enabling the independent blinded adjudication of clinical events for a large spectrum clinical trials, ranging from small scale studies to clinical trials with thousands of safety and efficacy events. We provide extensive adjudication committee management and coordination services to ensure top quality data, an efficient workflow […]
Site Management
Investigator and site staff training Appropriate training of investigators and site staff is key to your clinical trial’s success. The objective of such meetings is to educate the investigator and site staff on the investigational product, the background and the content of the protocol, the study conduct, event reporting, SAE reporting and GCP. Thorough training […]
Site Selection & Start-up
Feasibility and site selection We have a network consisting of a significant number of high quality clinical sites and many cross-links to other established clinical trial networks. We can run feasibility and site selection processes on a global level or on a country specific level. ITREAS operates a feasibility system that allows for investigator friendly […]
Data Management
Biostatistics A sound statistical design of your study is a precondition for bringing your study to a success. ITREAS has access to renowned academic epidemiologists and statisticians that can assist you in setting up a robust statistical protocol section with up to date and relevant literature references therewith improving your study design, whilst reducing costs. […]
Study Design & Leadership
Protocol development Our team and partners bring together years of writing experience and have (co-)authored a multitude of clinical research protocols. Each protocol ensures that the safety of the patients and integrity of the data collected is guaranteed and that the trial design is fully in line with ICH-GCP guidelines. We ensure that the background, […]