Starting with the study idea to the publication of results
IZKS delivers quality-oriented support to clinical researchers and scientists as well as public institutions and companies planning to conduct an Investigator Initiated Trial (IIT) or a Sponsor Initiated Trial (SIT) − starting with the study idea to the publication of results. Our services cover the development of a clinical trial concept, efficient execution of the clinical trial including all necessary tasks as well as comprehensive data analysis and statistical evaluation. Furthermore, IZKS also offers to take responsibility for the entire clinical trial coordination, including all transferable sponsoring tasks.
Main steps of a high-level clinical trial project at IZKS are as follows:
Developing a clinically-scientific objective
Drafting a clinically-scientific objective including background and rationale
Creating a clinical trial concept / clinical trial synopsis
Definition of all clinical, regulatory, statistical and financial requirements, support of application procedures for public funding
Setting up a detailed clinical-scientific clinical trial protocol
Support in creating a detailed time schedule for a clinical trial (Clinical Trial Protocol) as well as all essential clinical trial documents according to ICH GCP (e.g. patient education and consent form, electronical or paper based data documentation records)
Coordination and monitoring of the clinical trial in accordance with all legal requirements
GCP compliant project management of clinical trials, handling all relevant tasks in the fields of regulatory affairs, quality management, safety management and data management, data collection, data monitoring and statistical planning
Evaluation and interpretation of clinical trial results
Statistical analysis and creation of a detailed statistical clinical trial report in accordance with all applicable legal requirements
Publication of clinical trial results
Contributing to respectively creation of the publication of the study results
