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Peter Schiemann, PhD
Managing Partner and Co-Founder

peter schiemann.png
  • LinkedIn
  • 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

  • Quality Risk Management and Quality by Design

  • Chinese Drug Development Regulations

  • Risk-based Monitoring

  • Process analysis and re-engineering

  • Clinical Trial Management

  • SOP Systems and Process flow

  • Strategic R&D Advice

  • 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

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