CRS-Group > locations of CRS > Mönchengladbach > Virtual Tour 

Business Development

Dr. Nannette Fischer - Senior Manager Business Development
Ms. Jutta Hoge - Senior Manager Trial Finances & Business Development

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.

Quality Assurance

Dr. Corinna Reineke

The activities of the QA manager during the various stages of a clinical study cover a number of auditing processes. The kind of internal GCP-audits that may be performed during study preparation, clinical conduct, data management and reporting are summarized in a study-specific audit plan. The choice of the audits that will be performed for a specific study depend on the contractual agreements with the sponsor and the corresponding budget for QA activities. In addition to study-specific audits a number of internal system audits is performed on a regular basis (e.g. archive, emergency measures, SOP management). And last but not least, all our subcontractors are (re-) audited by our QA manager.

 

 

Monitoring

Ms. Göttmann (Monitoring) in dialogue with one of our physicians.

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.

Volunteer recruitment

Ms. Maassen
Ms. Nowak

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

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.

Clinical group

The clinical group consists of the most experienced and dedicated professionals with extensive experience in conducting clinical studies. Regularly training in GCP, clinical methods and emergency medicine are a fundamental part of our internal education programme.

Study preparation by Physicians and Nurses
Ms. Mueller-Renette, Laboratory Technican and Ms. Klein, Head Clinical Services
PK sampling
Centrifugation
Extraction of the serum
Storage under controlled conditions
Online documentation of the workflow.

Project Management

Dr. Marcus Engel - Senior Project Manager
Martina Erdmann - Project Manager

All studies contracted with CRS-Mönchengladbach are organized by our Project Managers. The organisation of the trial as well as the coordination of the communication between Sponsor, internal departments and our external partners is the primary function of the Project Management.

It ensures that two persons will be the main contact partners for the Sponsor during the clinical conduct of the trial. The Project Management is responsible for time and logistic planning, preparation of submissions to the EC and relevant authorities, management of the trial and keeping the communication process.

Informationen für Probanden

Wenn Sie uns als Proband bei der Entwicklung neuer Medikamente unterstützen möchten, besuchen Sie bitte www.probandeninfo.de.