Study planning/ preparation
We support you throughout the entire development cycle and in all phases (I – IV) of your clinical trial with medicinal products as well as during all your clinical trials with medical devices.
Monitoring & Study assistence
Depending on the individual requirements of your project regarding the monitoring strategy, we offer different approaches.
From database, (e)CRF creation, to data import, query management and plausibility checking.
Professional statistical advice to link the study results to the study questions using appropriate statistical methods.
The coding of the data with the Medical Dictionary for Regulatory Activities ensures a high quality of the data.
Whether as part of a clinical trial/NIS or as a stand-alone project - our professional medical writing team supports you with broad expertise and many years of experience.
Audit & Quality Assurance
Inspection preparation, training, coaching, implementation of standard operating procedures.
We are also happy to support you with your safety obligations in the context of conducting clinical and non-interventional studies.
We relieve you of the burden of planning, controlling, monitoring and completing projects.
customized solutions & individual advice.
Asking for support is a sign of strength: