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Beat Widler, PhD
Managing Partner and Co-Founder

  • LinkedIn
  • 25 years with Roche in Switzerland in the areas of regulatory affairs, clinical research and Quality Assurance & Risk Management;

  • 5 years Head of Pharma Development UK, Welwyn Garden City, providing leadership to 750+ drug development professionals.

  • Quality Risk Management & Quality by Design (QbD)

  • Process analysis and re-engineering in:

    • Clinical Trial Management and Monitoring

    • Pharmacogivilance

  • GCP Issue Management

  • SOP Development & Management

  • Regulatory Intelligence for Compliance

  • Quality Risk Management in Clinical Trials and Drug Safety - strategy, concept, methodology, process and organizational design and implementation

  • Built the Roche CQA department into a fully integrated Quality Management function providing quality risk management and QA oversight to the areas of Pharma clinical trials (phases (1-4) and Pharmacovigilance including CSV and vendor quality management aspects

  • Development of an SOP management system for a global software company

  • Leader of Task Force for QA- & GCP-- integration of Roche Japan development operations

  • Coordination and organization of FDA, EMA initiated inspections globally

  • Lead the Roche Clinical Trials Posting and Transparency Inititiative.  A team of Roche IT and medical writers with the support of CenterWatch and Boston Consulting Group building a web-based registry of Roche clinical trials and a database of trials' results

  • Developed and implemented the strategy for the off-shoring of all transactional Disclosure activities to a third-party service provider

  • Provided leadership to the Roche Ethics and Sustainability work groups.

  • Conducted more than 100 audits worldwide (e.g. Europe, Eastern Europe, US, Latin-America, Japan, Australia and China

  • Member of the Board of DIA and member of the strategy committee of EMPRA, an EU Commission project.

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