Composing the project managament-specific sections of the study protocol
In order to fill the different sections of a protocol with the correct information, we help you to better understand the individual chapters.
Compilation of study-specific documents
Based on your study protocol, we draft additional documents such as patient information, consent forms, advertisements and summaries.
Support on contract and insurance management
We will help you to find out which contracts are necessary within the scope of your study and provide you with appropriate document templates. We support you in taking out patient insurance policies.
Planning of Investigator Meetings
It can be difficult to bring investigators together, especially in larger studies with numerous participating centres. To this end, we help you to develop suitable concepts.
Organization of Data Monitoring Committees (DMCs)
DMCs can assess the safety and/or efficacy of a study intervention during the ongoing study. Their orientation and actions are based on a DMC charter. We support you both in the conception and in the implementation of your DMC charter.
Setup of newsletters
In order to inform and remind participating centres about ongoing studies, we design concise newsletters for you.
Contact person for additional study centres
In the case of multicentre studies, queries regarding the organisation and implementation of the study are raised frequently. Here, we offer the possibility of a "single point of contact" to bundle the information.
Support on the preparation of study reports
As a rule, a study report is prepared after completion of a clinical study. We offer professional assistance in the preparation of clinical study reports according to ICH-E3 guidelines ("Structure and Content of Clinical Study Reports").