Thomas Kissner

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clinical monitoring incl remote monitoring project management quality assurance quality risk management regulatory support biostatistics data management electronic data capture electronic patient reported outcome interactive response system medical writing product safety document management electronic trial master file electronic investigato site file quality controlled trial management system consulting legal representative training ichgcp iso 14155 data protection eu reg 2016 679 research services clinical trials clinical data management medical devices ivds regulatory affairs data analysis sponsorship as a service product vigilance clinical operations study coordination trial master file scientific writing gcp training remote trials feasibility studies data integrity risk management vendor management patient safety data compliance clinical research statistical analysis plan trial protocols clinical study reports operational oversight investigative sites statistical requirements database management team communication process development international trials training courses clinical research organizations compliance audits continuous professional development consultation services study design patient recruitment healthcare innovation clinical study expertise trial implementation collaborative research productivity information technology & services health care health wellness & fitness hospital & health care data analytics