Monitoring for all-time „Inspection Readiness“ of Clinical Trial Sites
From over 12 years of experience in monitoring clinical trials, we know how medical practices, clinic departments and study management organisations work, and how monitoring of these trial sites can be conducted efficiently. We know what works in monitoring clinical trials and what does not.
Based on this experience we have developed High Quality Monitoring, the monitoring of sites of clinical trials at a very high quality level. We have enhanced the monitoring of clinical trials with methods with which we achieve the all-time "Inspection Readiness" of the trial sites.
Our way of proceeding is designed to create a supporting and partnership-based atmosphere in the collaboration of our monitors with the study teams.
The mutual expectations of the cooperation are clearly communicated. This includes training aligned to the individual prior knowledge of the study team members, integrating study and trial sites processes, assistance in structured data capture and communicating clearly and committedly. Our experience shows that the investigational teams experience our monitoring as real partnership and not as surveillance.
Our highly efficient project teams take over all tasks that arise within the scope of clinical monitoring:
- Feasibility Analysis
- Site Selection
- Site Submission to Regulatory Bodies
- Negotiation and Management of Investigator Contracts
- Process Integration with Site Procedures
- Site Initiation
- Support of Investigator Teams
- Intermediate Site Monitoring
- Site Close-outs
With our High Quality Monitoring we ensure the correct conduct of all study-related tasks carried out by the study teams of trial sites within the scope of clinical trials from initiation to close-out and reach the goal of all-time "Inspection Readiness" of the trial sites participating in a study. This means that the respective trial site is ready for a visit by a regulatory inspector at any time, which may also be announced at short notice, and passes the inspection at least without any critical and major findings.
Biopharmaceutical and medical companies thus avoid the increased personnel resources for preparing audits and inspections and the associated costs for the later implementation of Corrective and Preventive Actions CAPAs.
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.
High quality monitoring is process- driven. To this end, we have graphically modelled the monitoring processes and placed them in our Collaboration Portal, which is accessible to all staff of our team. The processes in the portal are, quasi a graphical process manual.
Mandate us with the monitoring of your clinical trial, and experience a quantum leap in monitoring and ensuring the protocol-compliant conduct of all study-related tasks performed by the study teams of your trial sites!