A German, independent full-service consulting and clinical research organisation (CRO) with more than 25 years of expert experience in planning and conducting international and national pre-clinical and clinical trials as well as post-market surveillance studies offers services and consultation from the initial idea to authorisation and health services research based on a service agreement.
The German Clinical Research Organization (CRO) provides full CRO services and specialized consultation for prospective clinical trials. This includes expert planning and designing of translational studies and clinical trials, scientific consultation, the development of clinical protocols, the designing of case record forms (CRF) as well as recruitment, assessment and initiation of study centers.
The CRO also provides training for investigators and their staff. The CRO is able to act as principal clinical investigator and to take over trial management as well as monitoring during the trial and site management. The CRO prepares dossiers according to GCP (good clinical practice), ISO and national and international regulations for the approval by competent authorities. It has a profound expertise in biostatistics, medical writing and publication, pharmacovigilance and device vigilance as well as in regulatory affairs.
It assists in finding partners for clinical trials among German academic and clinical centers and research institutes. In addition, the CRO provides assistance with writing of applications for national and international grants as well as proposals for private investors.
The CRO offers its services in the framework of a service agreement to academic and industrial partners from biotech, medical device development or pharma as well as other CROs.
- Specific area of activity of the partner: The CRO is looking for partners from academia, biotech and pharma as well as medical technology companies who have to conduct clinical trials for the certification and approval of their products. A service agreement will provide the framework for the provision of services selected by the partner.
The CRO has over a decade of experience in hundreds of clinical trials and consulting projects of trials leading to CE conformity and new drug approvals in the EU.
The CRO brings proven and guaranteed quality standards as well as established standard operation procedures to the table.
The CRO can rely on its very good connections to experts in industry and academia.
The CRO is located in geographical proximity to many leading European research centers possessing professional structures in which dependable clinical studies are conducted. This enables the CRO to find partners even for projects with very special demands.