CRO Services

A scientifically sound planning of a clinical trial is essential for its successful conduct. Together with our well qualified partners we offer all services for a carefully planned trial in accordance to all regulatory and scientific requirements. Our services include amongst others, development of the trial design, protocol development, statistical planning including sample size estimation and randomization and CRF development.
A qualified trial management guarantees a seamless and on schedule conduct of the trial. Amongst others, we offer submission services, trial centre management and TMF management.
flexopharm® GmbH & Co. KG has a manufacturing permit according to § 13 AMG for trial medication. Thus, we are allowed to offer import of IMP, blinding and labelling of investigational drugs and shipment to the trial centres.
A careful monitoring improves the data quality of the trial and supports prompt data processing. A close co-operation to the investigators, the trial centre staff and the data management is essential. Together with our well qualified partner we offer monitoring services like monitoring plans, planning, conduct and reporting of qualification, initiation, monitoring and close-out visits as well as remote monitoring.
A qualified data processing is the base of clean and reliable data. For a good data quality it is essential to have validated data management processes and a close co-operation between monitor, data manager and statistician. Our well qualified partner CHRESTOS offers all data management services.
Scientifically sound and validated analysis of the trial data is the basis for the correct interpretation of the results. Our well qualified partner CHRESTOS offers all statistical services.
Scientific and profound presentation of the trial results in accordance to the guidelines and laws is essential for a successful project. Together with our well qualified partners we offer the medical writing services like generation of protocol, informed consent form and clinical trial reports according to ICH E3.
Quality assurance activities during the trial conduct guarantees the GCP compliance of the trial. We offer quality assurance services like risk-based planning of all quality assurance activities as well as conduct of audits and reviews.
Sponsors who are not based in the European Union (EU) must appoint a legal representative based in the EU. The EU legal representative does not endorse the sponsor’s responsibilities of initiating, managing and financing the clinical trial. The role of the EU legal representative is limited to civil and criminal liability: the competent jurisdiction of a specific member state, applying its own domestic law in terms of civil or criminal law, may engage the EU legal representative liabilities on behalf of the sponsor. We offer to undertake the role as a legal representative.