One of the most important requirements of current clinical studies is that all processes are documented within a study and thus the entire progression of the study becomes verifiable. The drug approval agencies have stipulated this so that they can review the correctness of the results and track all details up back to the source data and in the data collection sheets (Case Report Form (CRF)). In doing so, the authorizing agencies align themselves according to Good Clinical Practice (GCP).
Naturally, ClinStat complies with ICH/GCP guidelines as well as other national and international standards and regulations. This also includes our standard operating procedures (SOPs), which are a central component of quality assurance. All SOPs provide a thorough overview of the structuring of the processes, the competencies and responsibilities for tasks involving documentation with your clinical studies. Upon request, we can also align our work according to your SOPs.