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 CRS´ services, facilities and expertise. 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 Project Coordination, who will organise and set up the clinical trial as previously discussed.

Our Recruiting Nurses are well experienced in the efficient recruitment of healthy subjects, symptom carrying volunteers and patients. The CRS-Mannheim volunteer database permits the access to a large number of healthy volunteers and special populations including: Elderlies, postmenopausal women, young women without contraception, COPD-Patients, Diabetics, Allergics, Patients with Hyperlipidemia and Hypertensives.

All subjects of the CRS 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 CRS-Mönchengladbach have been genotyped with respect to their CYP 2C9, CYP 2C19 and CYP 2D6 metabolism and Mannheim is catching up to this.

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 volunteers and research.

If requested by the Sponsor, CRS-Mannheim is able to perform the monitoring according to ICH-GCP. To guarantee a high quality standard, CRS-Mannheim has established its own SOP for monitoring. Neverless, our trained monitors are also able to work according to Sponsor SOPs. At minimum, our monitor performs on-site monitoring before, during and after the study, which includes initiation visit, periodic monitoring visits and close-down visit. Amongst others we check:

• Administration of Investigational Medicinal Product
• 100% of the CRFs (Source Data Verification) including Adverse Events
• Investigator File (essential documents)
• Investigational Medicinal Products
• Informed Consent Forms
• Necessary formsheets

The basis of the QA group is located in Grünstadt in the CRS-Grünstadt facilities. Two QA co-workers are permanently present in the Mannheim clinic for QC purposes during study conduct.

The independent Quality Assurance department is responsible for performing audits during clinical and bioanalytical studies according to GCP, GLP, GMP and the respective legal requirements. This includes audits during planning (Study Protocol and related documents), performance (e.g. administration, measurements, sample collection and handling) and reporting (Study Report).

Furthermore, the department performs system audits inhouse and at external sites (e.g. the clinical laboratory).

Managing of the SOP system and the Quality Control system are other tasks which are under the responsibility of the department Quality Assurance.

The following inspections of authorities have been conducted at CRS-Mannheim (former IKP GmbH) since 2000: 

• GLP Inspection by national authority: 18.07 and 15.12.2000 
• GLP Inspection by national authority: 15. and 16.11.2004
• GMP Inspection by national authority: 05.10 and 21.11.2000 
• GMP Inspection by national authority: 23.08.2005 (external manufacturing site Fortuna Apotheke)
• GMP Inspection by national authority: 20.07.2006 
• FDA Inspection: 02.-06.12.2002  
• GCP Inspection by national authority: 08.05.2003
• Inspection by BfArM and AFSSAPS (German and French regulatory authority): 21.-24.07.2003

Quality control is routinely performed throughout a study by the Quality Control responsible of the department Clinical Trials Phase I-II reviewing the respective documents.  In order to guarantee high quality standards in the conduct of clinical trials, CRS-Mannheim has established several SOPs concerning Quality Control in the different areas.

Quality Control is done according to ICH-GCP, the Study Protocol and legal requirements for the blank CRF and the blank Subject Information sheet/Informed Consent Form. Part of this Quality Control are also the completeness of the essential documents prior to study start, the Investigational Medicinal Products and the different steps during the clincial part starting with the control of the Signed Informed Consent until 1000% Source Data Verfication.

Quality Control is also implemented in departments Data Management and Bioanalytics at various steps.