Clinical Trial Liaisons (CTL)
It is the objective of the Clinical Trial Liaison to reach the number of cases required for the clinical study within the shortest possible timeframe, keep as many patients as possible in the study until the entire completion of all study visits and to enable the protocol-compliant and efficient conduct of all study processes. The keys to this are a careful analysis of the recruitment potential of the trial sites and of all the clinical study processes in regards to their practical feasibility, as well as good relationships and a supporting and trustful collaboration with the investigators and their teams. [More ...]
Let’s talk about how we ensure the patient recruitment of your clinical study!
High Quality Monitoring (HQM)
High Quality Monitoring is the monitoring of trial sites of clinical trials at a very high quality level. The goal of High Quality Monitoring is "Inspection Readiness" of the trial sites participating in a study at any time. This is possible through sophisticated processes, transparent and complete reporting and the implementation of appropriate Corrective and Preventive Actions (CAPAS) in case of deviations from the planned study conduct. Let’s talk about your project and what we can do for you.
We enable this by effective und efficient study processes, supporting the study teams in structured data capture, training aligned to the individual prior knowledge of the study teams, risk-based monitoring, proactive management of trial sites, transparent and complete reporting and the implementation of appropriate Corrective and Preventive Actions (CAPAS) on deviations from the planned study course.
We work according to the current ICH GCP Guideline E6 (R2), the legislative regulations of the respective countries of the trial sites, and optionally the SOPs of the sponsor, the contract research organisation or our own process-driven SOPs. [More ...]
Let’s talk about how your trial sites become „inspection ready“ as well!