Clinical Trials
Full service or individual services tailored to your needs
Through efficient and reliable study management – from planning via implementation to a successful completion of a study – we reliably support our clients in order to relieve their planning and operational management workload. Our core competencies cover scientific advice, smooth organization and GCP compliant implementation of all kinds of studies. Our aim is to offer an individually tailored solution for each client.
All necessary regulatory and statistical aspects as well as considerations concerning data handling are taken into account in order to guarantee an optimal course of the study.
We support you throughout the entire development cycle and in all phases (Phase I – IV) of your clinical trial with medicinal products as well as during all your clinical trials with medical devices.
- Consultation on selection of study design
- Statistical aspects in planning of studies, sample size calculation, randomisation
- Preparation of study protocol/clinical investigation plan and additional documents (patient information leaflet, informed consent form, patient diary, etc.)
- Development of Case Report Forms (CRFs – paper or EDC)
- Submission to Ethics Committee and Competent Authority
- Site selection and feasibility check
- Import notifications/Import licences for medicinal products
- Trial Master File
- Risk analysis und development of a monitoring strategy
- Training of investigators and study nurses
- Organisation of investigator meetings
- Close cooperation with stduy sites (in- & outpatient), central laboratories & external experts
- Monitoring / Co-Monitoring
- Project management – only one contact person in charge of communication
- Documentation and logistics assistance at the study centre, query management
- Study supply management
- Data entry, biometrical evaluation of data, coding (MedDRA, ATC, WHO, etc.)
- Query management
- SAE responsibility
- Preparation of clinical study reports according to ICH guidelines (E3) and clinical investigation reports according to EN ISO 14155
- Preparation of publication manuscripts
- Quality Assurance (Audits)