Business Development is your first contact and moderates the communication between the sponsor and the clinical team. The department has a strong academic background including clinical and pre-clinical experience, which enables a support in technical, scientific and also financial aspects in the early stage of the study application process.

Our Business Development team informs you about the services, facility and expertise of the CRS-Group. Moreover, this department will be your first contact to handle your project. In close association with the clinical department, the Business Development team goes through each trial enquiry to check its feasibility, bring construc­tive suggestions and comments and evaluate on measure the global amount of work and costs for the performance of the trial, according to its precise design.

The Business Development team is responsible for all preliminary information and support until a trial is contracted. After this stage, your project is immediately handed over to our Site and Project Management, who will organise and set up the clinical trial as previously discussed.

Our volunteers secretaries are well experienced in the efficient recruitment of healthy and symptom carrying volunteers. The volunteer database permits the access to a large number of healthy volunteers and special populations including elderly, postmenopausal women, extensive/poor metabolisers and allergics.

All the healthy male and female volunteers of the panel have passed an extensive medical examination. Only volunteers fitting to our standard inclusion criteria will be admitted and registered in our volunteer database. Many of the healthy volunteers in the panel have been genotyped with respect to their CYP 2C9, CYP 2C19 and CYP 2D6 metabolism. More recently, to face an increasing demand, we have started to screen volunteers with respect to their lipid status, in order to identify and categorise subjects suffering from dyslipideamia and constitute a specific panel accordingly.

Prior to the trial participation, each subject will be entered into a national central database (VIP Check®, Freiburg, Germany) in order to check his/her waiting periods. This procedure reduces the risk of unwanted drug interactions and undesirable consequences for the volunteers and the research.

Basic quality control is routinely performed throughout the study by the responsible (sub-)in-vestigator and nurses specifically designated for each study. In order to guarantee high quality standards in the conduct of clinical trials, CRS-Moenchengladbach has made part of its SOPs and taken as a standard rule to designate a responsible internal monitor for each study. He checks 100% of the case report forms and controls the clinical activities "on site", according to ICH-GCP and protocol. For us, this is a minimum; additional and complementary services may be provided by our monitor on request. Furthermore, our internal monitors accompany and support the external monitor during his visits at CRS-Mönchengladbach.

This team is responsible for the quality control of internal processes during clinical trials and also for reviewing CRFs and source documents. Study data is subject to multiple quality control reviews; each CRF file is thoroughly checked by our monitoring team to ensure accuracy, consistency and protocol adherence of the data prior to release to Data Management.