Peter Schiemann, PhD
Managing Partner and Co-Founder

11 years industry experience with Roche in Switzerland and the US (Trade Packaging, In-Process Control, Clinical Supplies, Clinical Audit Planning, Quality Risk Management)
4 years with PricewaterhouseCoopers (PwC) in Switzerland and the US (R&D Strategy consulting)
3 years academic research in Germany

Lead, created and implemented a novel Quality Risk Management approach in Clinical Trials and Drug Safety at major pharmaceutical company including strategy, concept, methodology, process and organizational design and implementation
Initiated major Clinical Trials Phase IIIb/IV re-engineering project at a major pharmaceutical company including design and implementation while serving on the steering committee and as major contributor in multiple work streams
Implemented system for clinical trials and quality management, involving regulatory, quality, clinical, manufacturing and medical departments for biotech start-up
Lead a Risk-based Monitoring project a mid size Pharmaceutical Company
Lead the team for the analysis of an R&D strategy and organizational set up of a small US Biotech company including development of a restructuring plan and recommendations for a strategy shift
Development and implemented Clinical Quality Management Systems at various clients (small and mid size), including SOPs in Europe and China
Trainer on standard course on Risk-based Monitoring and targeted Source Data Verification
Re-engineered a system for quality management, clinical trials, manufacturing and marketing for a medical device company
Performed numerous key organizational analyses including R&D, Manufacturing and IT processes
Close contact with regulators at FDA, EMA, NMPA (former CFDA), BfArM, MHRA, ANSM and others
DIA QRM SIAC Chair and ACRES IT systems workstream co-chair