It is always the result of intelligent effort."
Look beyond what’s expected.
- Systems/Process Audits for Drugs and Medical Devices
(Investigational Sites, CROs, Sponsors)
- Remote Audits (especially for Russia and Ukraine)
- Trial Master File Audit
- Quality Checks
- Root Cause Analysis & CAPA
- Peer Review
- QMS setup and maintenance
- SOP writing
- Interim Quality Assurance Manager
Discover deep insights and better answers.
Planning, initiation, controlling and finalization of multicenter, international phase I-IV clinical studies including production planning and distribution of the investigational medicinal product.
Supporting Regulatory Affairs, submission to the Regulatory Authorities.
Let's do better, together.
Monitoring of Phase I - IV and Medical Devices Clinical Trials
Co-Monitoring / Coaching and Training of Monitors
Available expertise in at least the following therapeutic areas:
Oncology, Immunology, Nutrition, Central Nervous System, Respiration, Volume Replacement, Organ Transplantation, Dermatology, Immunization, Gastroenterology, Narcotic Substances.
MDR-Studies: Renal Denervation, Deep Brain Stimulation, Back/Leg Pain
Ready for today, prepared for tomorrow.
- Investigators and Study Teams including Study Nurse Trainings
- Clinical Monitor
- GCP and Regulatory/Ethical Requirements in Clinical Research
- SOP Training
- Communication Skills
Language: German, Russian or English