Founder, Manager, Cra, Consultant
Berlin Area, Germany
Site monitoring at controlled clinical trials in Germany. Support of clinical developments and clinical studies. Clinical trial management. Spot consulting for pharmaceutical and medical devices/diagnostics companies.Consulting and training for entrepreneurs and startup companies in technology-oriented areas (medical devices, pharma, ICT, industry 4.0) and social entrepreneurship.Professional training (including practical courses) in clinical trials: Declaration of Helsinki, German Drug Law and other regulations, IEC approval, site monitoring / site visits, biometrics, essential study documents and CRFs, AEs/SAEs/SUSAR definition and reporting, document archiving, site master files and trial master files, reporting, drug safety and drug accountability, SOPs, quality management, data management, site management, approval processes, pharmacovigilance, audits and inspections, medical devices regulations, technical English, communication and presentation techniques. Achieved top grade during the training. Obtained an actual certificate in ICH-CGP.